Archive for January, 2014

(DMRC) Sets New Guinness World Record at NRF 2014 for Fastest Retail Checkout

Digimarc(R) Barcode Delivers Lightning-Fast Checkout Time of 51.91 Seconds — an Unprecedented 58 Items-per-Minute Pace

BEAVERTON, OR and NEW YORK, NY–(Jan 14, 2014) – NRF Booth #132 — Digimarc Corporation (NASDAQ: DMRC) today announced it has set a new Guinness World Record for fastest time to scan and bag 50 items at National Retail Federation’s Annual Convention & EXPO (Retail’s BIG Show) 2014. With a Guinness World Record adjudicator present, company representatives scanned and bagged 50 items featuring the newly released Digimarc® Barcode in 51.91 seconds — bettering the previous record of 75 seconds. The items were scanned using a Datalogic Magellan™ 9800i multi-plane imaging scanner and an HP rp5800 POS system.

Attendees of the show witnessed the record-setting event at the Digimarc Booth #132 yesterday, Monday, January 13 at 3 PM ET. The record was set by Digimarc’s Ed Knudson, Executive Vice President, Sales and Marketing, and Sean Calhoon, Senior Director, Product Management, neither of whom have any professional checking or bagging experience. Adhering to Guinness’ guidelines, the team switched scanning and bagging duties after 25 items, placed exactly 10 items in each bag and included the 2014 Guinness Book of World Records itself as the last item scanned. All 50 items appeared correctly on the printed receipt, stopping the clock to establish a game-changing pace of 58 items-per-minute.

“It’s amazing how fast you can scan when you don’t have to hunt for the UPC code,” said Knudson. “This is a great accomplishment for the entire Digimarc team, but what we’re most excited about is bringing the Digimarc Barcode to retailers and brands. It’s not only going to dramatically speed checkout, which increases customer satisfaction and improves margins for retailers, it will also enable deeper engagement with today’s mobile-enabled shoppers.”

In a typical retail environment, professional checkers will be able to leisurely scan packages at rates exceeding 36 items per minute, compared to the industry average of 24 items per minute when scanning traditional UPC codes. The Digimarc Barcode is invisibly distributed over the entire surface of the package, eliminating the need for clerks, as well as shoppers using self-checkout, to find and position the barcode toward the reader. The Digimarc Barcode requires no special inks, printing processes or modifications to today’s POS systems. Learn more about this breakthrough in retailing technology at www.digimarc.com/retail.

About Digimarc
Digimarc Corporation (NASDAQ: DMRC), based in Beaverton, Oregon, is a leading innovator and provider of consumer engagement, media management, and security solutions that create digital identities for all forms of media and many everyday objects. Digimarc’s digital IDs are imperceptible to humans and enable computers, networks and devices like mobile phones to better “see, hear and understand” brand impressions and other objects of interest. Digimarc has built an extensive intellectual property portfolio with patents in digital watermarking, content identification and management, media and object discovery to enable ubiquitous computing and related technologies. Digimarc develops solutions, licenses its intellectual property, and provides development services to business partners across a range of industries. For more information and the latest news, please visit www.digimarc.com and follow us on Twitter @DigimarcCorp.

Datalogic is a registered trademark of Datalogic S.p.A. in many countries, including the U.S.A. and the E.U. Magellan is a registered trademark of Datalogic ADC in many countries, including the U.S.A. and the E.U.

Tuesday, January 14th, 2014 Uncategorized Comments Off on (DMRC) Sets New Guinness World Record at NRF 2014 for Fastest Retail Checkout

(MNOV) Prepares to Initiate Phase 2 NASH Trial in the U.S.

SAN DIEGO, Jan. 14, 2014  — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a study that examined the potential clinical efficacy of MN-001 for the treatment of NASH (nonalcoholic steatohepatitis).

MN-001 administered orally once daily (10, 30, and 100 mg/kg) for 3 weeks, was evaluated in the STAM™ (NASH-HCC) mouse model of nonalcoholic steatohepatitis, as measured by liver biochemistry and histopathology, NAFLD activity score (NAS), and percent of fibrosis and gene expression.

MN-001, in a dose-dependent manner, significantly reduced fibrosis area compared with vehicle (p <0.01) as demonstrated by a reduction in liver hydroxyproline content, supporting MN-001’s anti-fibrotic properties. MN-001 significantly improved NAS (p <0.01), and this was most likely attributed to the reduction in lobular inflammation and hepatocyte ballooning, the latter being most notable. Hepatocyte ballooning is thought to be derived from oxidative stress-induced hepatocellular damage and is associated with disease progression of NASH. MN-001, in this animal model, improved NASH pathology by inhibiting hepatocyte damage (p <0.01) and ballooning (p <0.01).

Congruently, MN-001 was shown to down-regulate certain gene expression levels in the liver. At low and mid doses, MN-001 significantly down-regulated MCP-1 (p <0.01) and CCR2 mRNA (p < 0.01) expression levels compared to vehicle. Similarly, MN-001 significantly down-regulated Collagen type 1 (p <0.01) and TIMP-1 mRNA (p <0.001) expression levels at low and mid doses. These gene expression data imply that MN-001 prevents the formation of fibrosis in the NASH model.

Collectively, these results provide compelling evidence that MN-001 warrants further evaluation for the treatment of NASH in humans. Accordingly, MediciNova is preparing to initiate a Phase 2 trial for the treatment of NASH in the U.S.

About MN-001

MN-001 is a novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory activity in preclinical models. It is postulated that inhibition of the 5-LO pathway exerts anti-inflammatory actions, which has implications in various inflammatory diseases such as arthritis, osteoarthritis, allergy, and asthma (Martinez-Clemente et al 2011). Recently, 5-LO has been postulated as a pathogenic factor in liver injury (Titos et al 2010). MN-001 is thought to exert an inhibitory effect on 5-LO and the 5-LO/LT pathway, which is considered to be a novel target for fatty liver disease.

Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in asthma and completed a Phase 2 study in asthma with positive results. This compound has been exposed to more than 600 subjects. MN-001 was considered generally safe and well-tolerated.

About NASH (nonalcoholic steatohepatitis)

According to the National Digestive Diseases Information Clearinghouse (NDDIC), NASH prevalence in the U.S. is 2-5%. An additional 10-20% of Americans have fat in their liver, but no inflammation or liver damage, a condition called “fatty liver.” The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese. Many patients with NASH have elevated serum lipids, diabetes or pre-diabetes. Progression of NASH can lead to liver cirrhosis. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. At this time, there is no treatment for NASH.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders, MN-221 for the treatment of acute exacerbations of asthma, and MN-001 for NASH. MN-166 is being developed in multiple indications, largely through investigator-sponsored trials and outside funding. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-001 for the treatment of NASH. These forward-looking statements may be preceded by, followed by or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-001 for the treatment of NASH and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2012 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

CONTACT: INVESTOR CONTACT:
         Geoff O'Brien
         Vice President
         MediciNova, Inc.
         obrien@medicinova.com
Tuesday, January 14th, 2014 Uncategorized Comments Off on (MNOV) Prepares to Initiate Phase 2 NASH Trial in the U.S.

(CYTR) Doses 1st Patient in Phase 2 Clinical Brain Cancer Trial with Aldoxorubicin

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the first patient has been dosed in the Company’s Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.

“With the dosing of the first patients we are on schedule with this important Phase 2 GBM trial, and look forward to reporting preliminary results in the second half of this year,” said CytRx President and CEO Steven A. Kriegsman. “Aldoxorubicin has been shown to have the unique ability to cross the blood-brain barrier in animal models of human glioblastoma, potentially creating a new approach to attacking brain tumors. Should the data from this trial be positive, we will pursue the rapid development of aldoxorubicin for unresectable GBM, including filing for ‘breakthrough therapy’ designation with the U.S. Food and Drug Administration, which could expedite marketing approval.”

The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) and overall survival (OS) according to RANO Working Group Criteria. The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events. The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response will be monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, Calif., City of Hope in Duarte, Calif. and the Louisiana State University Health Sciences Center in New Orleans.

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.

About Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common and most malignant brain tumor in adults, and afflicts more than 12,500 new patients in the U.S. annually. The five-year survival rate is approximately 4%. Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is about 12 to 14 months. Although treatment failure may be due to several factors, limited efficacy of chemotherapeutic agents has been attributed to several contributing factors, including insufficient drug delivery to the tumor site through the blood-brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and plans to initiate a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that any future human testing of aldoxorubicin, including the Phase 2 study of aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), might not produce results similar to those seen in past human or animal testing, including the mouse study described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Tuesday, January 14th, 2014 Uncategorized Comments Off on (CYTR) Doses 1st Patient in Phase 2 Clinical Brain Cancer Trial with Aldoxorubicin

(NIHD) And Telefonica Do Wholesale Voice/Data For Nextel In Brazil, Mexico

— The agreements significantly expand Nextel’s voice and data coverage in Brazil and Mexico using Telefonica’s networks, while increasing the efficiency of infrastructure investments for both parties

MADRID and RESTON, Va., Jan. 13, 2014 — Telefonica [NYSE: TEF] and NII Holdings [NASDAQ: NIHD]  have signed agreements whereby Telefonica will provide NII’s subsidiaries, operating under the Nextel brand in Brazil and Mexico, nationwide voice and data coverage services on Telefonica’s 3G wireless networks. When implemented, the agreements will expand the areas in which Nextel customers using 3G services in Brazil and Mexico can access voice and data services, supporting NII’s growth strategy. Both companies will work closely to implement the agreements as soon as possible. Telefonica and NII’s subsidiaries will continue to manage their spectrum and network assets separately to provide competing services.

In Brazil, the announcement demonstrates the commitment of both operators to create a dynamic competitive environment and is a natural step forward in the networks optimization process. This agreement will allow Vivo, Telefonica’s commercial brand in Brazil, to more efficiently deploy its network while providing Nextel with access to a broader service area across Brazil. Nextel Brazil will continue to expand its own network while complying with the regulatory coverage requirements imposed by the Brazilian Telecommunications Regulator (“Anatel”).

In Mexico, the commercial agreement will allow Movistar, Telefonica’s commercial brand in the country, to leverage the capacity already deployed in its 3G network and will provide another lever for strengthening its wholesale strategy in the country. Additionally, it will allow Nextel Mexico to expand its network footprint beyond its current coverage. Moreover, it shows the commitment of both companies to efficiently provide additional services to the marketplace consistent with the goals of the telecommunications regulation reform initiatives that are being implemented in Mexico.

“The agreement allows both companies to capture the benefits derived from the optimization of infrastructure investment while maintaining the current market structure in both Brazil and Mexico,” said Santiago Fernandez Valbuena, Chairman and CEO of Telefonica Latin America. “It is another example of Telefonica’s effort to optimize resource usage, improve profitability of the businesses and increase financial flexibility.”

“Our new agreements with Telefonica will enhance our service offerings by giving us the ability to provide our 3G customers in Brazil and Mexico with services in more areas in those markets,” said Steve Shindler, NII Holdings’ Chief Executive Officer. “Our access to Telefonica’s networks under these agreements will also allow us to utilize Telefonica’s networks as we continue to expand our own coverage footprint to provide our customers with service that meets their needs.”

The agreements reached with Nextel are in line with other announcements that Telefonica has made in recent months, such as the agreement signed with Millicom to deploy 4G-LTE networks in Colombia, the MVNO deals with Virgin Mobile in Mexico, Chile and Colombia and the agreement with lusacell for reciprocal use of wholesale services in Mexico that started in 2012.

About Telefonica
Telefonica is one of the largest telecommunications companies in the world in terms of market capitalisation and number of customers. From this outstanding position in the industry, and with its mobile, fixed and broadband businesses as the key drivers of its growth, Telefonica has focused its strategy on becoming a leading company in the digital world.

The company has a significant presence in 24 countries and a customer base that amounts more than 320 million accesses around the world. Telefonica has a strong presence in Spain, Europe and Latin America, where the company focuses an important part of its growth strategy.

Telefonica is a 100% listed company, with more than 1.5 million direct shareholders. Its share capital currently comprises 4.551.024.586 ordinary shares traded on the Spanish Stock Market (Madrid, Barcelona, Bilbao and Valencia) and on those in London, New York, Lima, and Buenos Aires.

About NII Holdings, Inc.
NII Holdings, Inc., a publicly held company based in Reston, Va., is a provider of differentiated mobile communication services for businesses and high value consumers in Latin America. NII, operating under the Nextel brand in Brazil, Mexico, Argentina and Chile, offers fully integrated wireless communications tools with digital cellular voice services, data services, wireless Internet access and Nextel Direct Connect® and International Direct ConnectSM, a digital two-way radio. NII is a Fortune 500 and Barron’s 500 company, and has also been named one of the best places to work among multinationals in Latin America by the Great Place to Work® Institute. The company trades on the NASDAQ market under the symbol NIHD. Visit the company’s website at www.nii.com.

Nextel, the Nextel logo and Nextel Direct Connect and International Direct Connect are trademarks and/or service marks of Nextel Communications, Inc., and are used by NII’s subsidiaries under license in Latin America.

Visit NII Holdings’ news room for news and to access our markets’ news center at www.nii.com/newsroom.

Safe Harbor Statement

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release regarding expectations, including availability of services, forecasts regarding operating results, performance assumptions and estimates relating to costs and capital requirements, as well as other statements that are not historical facts, are forward-looking statements. When used in this press release, these forward-looking statements are generally identified by the words or phrases “would be,” “will allow,” “expects to,” “will continue,” “is anticipated,” “estimate,” “project” or similar expressions. While the Company provides forward-looking statements to assist in the understanding of its anticipated future financial performance, the Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date of this report. Forward-looking statements are based on current expectations and assumptions that are subject to significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any updates to forward-looking statements to reflect events after the date of this report, including unforeseen events. We have included risk factors and uncertainties that might cause differences between anticipated and actual future results in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, as well as in other reports filed from time to time with the Securities and Exchange Commission.

Media Contacts:

Telefonica S.A.
Distrito Telefonica
Ronda de la Comunicacion, s/n
28050 Madrid
+34 91 482 38 00
www.telefonica.com

Investor Relations: Pablo Eguiron
ir@telefonica.es
+34 91 482 87 00

Media Relations: Miguel Garzon
prensa@telefonica.es
+34 91 482 38 00

NII Holdings, Inc.
1875 Explorer Street, Suite 1000
Reston, VA. 20190
(703) 390-5100
www.nii.com

Investor Relations: Tahmin Clarke
(703) 390-7174
tahmin.clarke@nii.com

Media Relations: Claudia Restrepo
(786) 251-7020
claudia.restrepo@nii.com

Monday, January 13th, 2014 Uncategorized Comments Off on (NIHD) And Telefonica Do Wholesale Voice/Data For Nextel In Brazil, Mexico

(OGEN) States that Its Policy is Not to Comment on Unusual Market Activity

Oragenics, Inc. (NYSE MKT:OGEN) (the “Company”) today announced that in view of the unusual market activity in the Company’s stock, the NYSE MKT (the “Exchange”) has contacted the Company in accordance with its usual practice. The Company stated that its policy is not to comment on unusual market activity.

About Oragenics, Inc.

Oragenics, Inc. is focused on becoming the world leader in novel antibiotics against infectious disease and probiotics for oral health in humans and pets. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon Corporation Inc., a synthetic biology company. The collaborations will allow Oragenics access to Intrexon’s proprietary technologies with the idea of accelerating the development of much needed new antibiotics that will work against resistant strains of bacteria and new therapeutic probiotics designed to alleviate symptoms from oral diseases. Oragenics also develops, markets and sells proprietary OTC probiotics specifically designed to enhance oral health for humans and pets, under the brand names Evora and ProBiora in more than 13 countries worldwide.

For more information about Oragenics, visit www.oragenics.com. Follow Oragenics on Facebook and Twitter.

Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect management’s current views with respect to future events and performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to those described in the filings of Intrexon and Oragenics with the U.S. Securities and Exchange Commission. Any responsibility to update forward-looking statements is expressly disclaimed.

Monday, January 13th, 2014 Uncategorized Comments Off on (OGEN) States that Its Policy is Not to Comment on Unusual Market Activity

(ALNY) Genzyme and Alnylam Expand Collaboration on Rare Genetic Diseases

– Genzyme to Obtain Significant Global Rights to Alnylam’s Pipeline –

– Alnylam Retains Most Product Rights in North America and Western Europe –

– Genzyme Becomes Major Alnylam Shareholder through $700 Million Equity Investment –

PARIS and CAMBRIDGE, Mass., Jan. 14, 2014 — Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced today that they have significantly expanded their strategic agreement to develop and commercialize treatments for rare genetic diseases. Genzyme will have significant rights to Alnylam’s portfolio of clinical and pre-clinical stage drug candidates. Alnylam will retain most product rights in North America and Western Europe, and will have significantly expanded development and commercial opportunities for its genetic medicine pipeline through Genzyme’s established global infrastructure in rare diseases.

This collaboration is an important building block for our future. It strengthens our pipeline and provides us with the opportunity to meet the needs of patients with rare diseases around the world through our well-established global organization,” said David Meeker, MD, Genzyme’s President and CEO. “This transaction also powerfully underscores Sanofi’s commitment to investing in Genzyme as one of the company’s key growth drivers. Our partnership with Alnylam has been highly collaborative, and their world-class RNAi technology holds the promise to provide a platform for sustained drug development for rare genetic diseases for years to come.”

This new relationship with Genzyme is transformational for Alnylam.  It is a game changer for both the advancement of RNAi therapeutics as a new class of genetic medicines to patients around the world, and for our commitment to build a leading, independent biopharmaceutical company that delivers value to our shareholders,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam.  “In this new alliance, Alnylam benefits enormously from Genzyme’s proven global capabilities, enabling us to accelerate and expand market access for our ‘Alnylam 5×15’ products.

In 2012, Alnylam and Genzyme formed an exclusive alliance to develop and commercialize Alnylam’s lead product, patisiran, which is in Phase 3 development for the treatment of transthyretin (TTR)-familial amyloid polyneuropathy, a rare life-threatening disease that damages the nervous system.

The expanded relationship between Genzyme and Alnylam includes the following components:

First, Genzyme will obtain expanded rights to patisiran. Under the original agreement from 2012, Genzyme had rights to commercialize patisiran in Japan and the broader Asia-Pacific region. This disease has a disproportionately high prevalence in these territories. Under the expanded agreement, Genzyme will now commercialize patisiran in all territories outside of North America and Western Europe, which are retained by Alnylam for their commercialization.

Second, Genzyme will obtain rights to commercialize worldwide three products in Alnylam’s pipeline. Specifically, (1) Genzyme and Alnylam will co-develop and co-commercialize ALN-TTRsc, a product currently in Phase 2 development for the treatment of familial amyloid cardiomyopathy, in North America and Western Europe, while Genzyme commercializes the product in the rest of world; (2) Genzyme will have the rights to two additional products after the completion of early clinical trials and will be able to choose between full global rights or co-commercialization rights, depending on the product.

Third, Genzyme will have the option up until 2020, with the possibility of extension through the end of 2021,to develop and commercialize outside of North America and Western Europe all products being developed to treat rare genetic diseases from Alnylam’s pipeline. Alnylam retains its rights to co-develop and co-commercialize its genetic medicine pipeline in North America and Western Europe.

Finally, Genzyme will become a major Alnylam shareholder with a stake of approximately 12% percent through a $700 million investment at a price of approximately $80/share, which represents a 27% premium as compared to the average share price over the last 30 days. In addition, Alnylam will receive R&D funding, starting on January 1, 2015, for programs where Genzyme has elected to opt-in for development and commercialization. Further, Alnylam is eligible to receive milestones and royalties.

This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act.

Conference Call Information

Alnylam and Genzyme management will discuss this new alliance in a conference call on January 13, 2014 at 9:00 am ET (6:00 am PT).  A slide presentation will also be available on the News & Investors page of the company’s website, www.alnylam.com, to accompany the conference call.  To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 31887205. A replay of the call will be available beginning at 12 :00 pm ET (9 :00 am PT) on January 13, 2014. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international), and refer to conference ID 31887205.

About Alnylam

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases. As part of its “Alnylam 5×15” strategy, as updated in early 2014, the company expects to have six to seven genetic medicine product candidates in clinical development – including at least two programs in Phase 3 and five to six programs with human proof of concept – by the end of 2015.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com. Genzyme® is a registered trademark of Genzyme Corporation.  All rights reserved.

About Sanofi

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Alnylam Forward-Looking Statements

Various statements in this press release concerning Alnylam’s future expectations, plans and prospects, including without limitation, Alnylam’s views with respect to the potential for RNAi therapeutics, including the programs in its 5×15 pipeline, Genzyme’s participation in the development and commercialization of RNAi therapeutics, its expectations regarding the receipt of potential R&D payments, development and sales milestones and royalties from Genzyme, and its expectations regarding available cash for its operations through multiple product launches, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, Genzyme’s ability to successfully advance patisiran, ALN-TTRsc and other products in the Genzyme territory, resulting in the potential payment of milestones and royalties to Alnylam, as well as Alnylam’s ability to develop and commercialize such products in the rest of the world, the parties ability to successfully co-develop and co-promote ALN-TTRsc and potentially a second product in North America and Western Europe, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC.  In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date.  Alnylam explicitly disclaims any obligation to update any forward-looking statements.

Contacts:Sanofi Media Relations

Jack Cox

Tel: +33 (0) 1 53 77 94 74

E-mail: mr@sanofi.com

Sanofi Investor RelationsSébastien Martel

Tel: +33 (0) 1 53 77 45 45

E-mail: ir@sanofi.com

Genzyme Media Relations
Lori GorskiTel: 617-768-9344

E-mail: Lori.gorski@genzyme.com

Alnylam

Cynthia Clayton

Tel: 617-551-8207

Email: cclayton@alnylam.com

Sanofi Investor RelationsKristen Galfetti

Tel: +1 908 981 5560

E-mail: ir@sanofi.com

 

Monday, January 13th, 2014 Uncategorized Comments Off on (ALNY) Genzyme and Alnylam Expand Collaboration on Rare Genetic Diseases

(ATNM) Actinium Presenting at Biotech Showcase™ 2014 Today

Actinium Pharmaceuticals, Inc. (OTCQB: ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, is presenting today at 4:30 pm Pacific. Dr. Kaushik J. Dave, President and CEO, will present a corporate update at the Biotech Showcase™ 2014.

Presentation Information:
Date: Monday, January 13, 2014
Time: 4:30 pm Pacific
Location: Parc 55 Wyndham Hotel: Mission II Room, San Francisco, CA
Webcast: http://www.media-server.com/m/p/qbc4c7nh

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.

For more information:

Visit our web site www.actiniumpharmaceuticals.com

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Monday, January 13th, 2014 Uncategorized Comments Off on (ATNM) Actinium Presenting at Biotech Showcase™ 2014 Today

(ATNM) Closes on Approximately $6.6 Million in Private Placement

Actinium Pharmaceuticals, Inc. (OTCQB:ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced that it has closed the final tranche of approximately $3,310,860 to bring total gross proceeds of approximately $6,636,720 million from the private placement of common stock and warrants to new and existing accredited investors (the “Offering”). The aggregate offering amount of securities sold to investors was increased from $6,000,000 to $6,636,700 in order to cover over-allotments. The proceeds of the Offering will be used primarily for further development of Iomab™-B, a Phase 3 clinical stage bone marrow conditioning agent for preparing patients for hematopoietic stem cell transplantation (HSCT) and Actimab-A, Actinium’s lead drug candidate in multicenter Phase 1/2 trials in Acute Myeloid Leukemia (AML).

“This funding gives us additional capital to prepare for the pivotal trial Phase 3 trial of Iomab™-B as a potentially curative treatment regimen for elderly AML patients preparing for a bone marrow transplant,” said Kaushik J. Dave, President and CEO of Actinium. “In addition, we will continue the Phase 1/2 proof of concept trial of Actimab-B as an induction therapy for elderly AML. Both Iomab™-B and Actimab-A address areas of cancer treatment where there are no FDA approved medications”.

Under the terms of the Offering, the Company sold approximately 1,106,120 shares of common stock at $6.00 per share and issued 276,529 five-year warrants exercisable at $9.00 per share.

Laidlaw & Co. (UK) Ltd., a FINRA-registered broker dealer, acted as the exclusive placement agent with respect to the Offering.

The offer and sale of the securities have not been registered under the Securities Act of 1933, as amended, and the shares may not be offered or sold in the United States absent registration under such act and applicable state securities laws or an applicable exemption from those registration requirements. The Company has agreed to file a registration statement covering the resale of the common stock and shares of common stock issuable upon exercise of the warrants issued in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

The foregoing is not a complete summary of the terms of the transactions contemplated by the Purchase Agreement and reference is made to the complete text of the Purchase Agreement, Subscription Agreement, Registration Rights Agreement, Form of Warrant and Form of Lock Up which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.

About Iomab™-B

Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant which is the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission will include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The study design of the pivotal trial is based on results of an earlier Phase 1/2 trial in which sixty percent of the older patients with refractory and relapsed AML exhibited disease free survival estimated at six months. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months. There are currently no treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab™-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to a bone marrow transplant in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab™-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

Iomab™-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine 131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

About Actimab-A

Actimab-A, Actinium’s second program is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single arm multicenter trial. The Company expects to make significant progress in the Phase 2 portion of the trial and announce interim results in 2014. Actimab-A is being developed as a first line therapy and has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile.

Actimab-A consists of the Lintuzumab monoclonal antibody and actinium 225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Lintuzumab is the humanized version of M195 and is a monoclonal antibody that targets CD33, found on myeloid leukemia cells. Both the alpha particle technology and lintuzumab were initially developed at Memorial Sloan Kettering Cancer Center.

For more information:

Visit our web site www.actiniumpharmaceuticals.com

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Monday, January 13th, 2014 Uncategorized Comments Off on (ATNM) Closes on Approximately $6.6 Million in Private Placement

(CRMD) Awarded European Patent for Neutrolin

BRIDGEWATER, N.J., Jan. 10, 2014  — CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardio-renal and infectious disease, today announced that the European Patent Office (“EPO”) has granted a European patent for a low heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter (sometimes referred to as “the Prosl patent”). The Company is the exclusive worldwide licensee of European Patent EP 1 814 562 B1, which was granted on January 8, 2014.

“The issuance of the Prosl patent is a significant addition to our intellectual property portfolio in the EU,” said Randy Milby, CorMedix Chief Executive Officer. “This patent will strengthen our ability to compete with other catheter lock solutions and help raise the standard of catheter care Europe.”

About CorMedix

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix’s first commercial product  is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients. Please see the company’s website at www.cormedix.com for additional information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: risks of launch and market acceptance of our products; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; CorMedix’s ability to maintain its listing on the NYSE MKT; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness; CorMedix’s ability to enter into and maintain collaborations with third parties for its development programs; CorMedix’s dependence on its collaborations and its license relationships; achieving milestones under CorMedix’s collaborations; CorMedix’s dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Friday, January 10th, 2014 Uncategorized Comments Off on (CRMD) Awarded European Patent for Neutrolin

(APFC) To Be Acquired By H.I.G.

LAS VEGAS, Jan. 10, 2014 — American Pacific Corporation (NASDAQ: APFC) (“AMPAC”) today announced that it has entered into a definitive merger agreement to be acquired by investment funds managed by H.I.G. Capital, LLC (“H.I.G.”), a leading global private investment firm in an all cash transaction valued at approximately $392.0 million.

Under the terms of the merger agreement, affiliates of H.I.G. will, no later than January 24, 2014, commence a tender offer to acquire all of the outstanding shares of AMPAC common stock at a price of $46.50 per share.  This price represents a premium of 18.9% over the closing share price on January 9, 2014, and 17.1% over the 60-day volume-weighted average closing share price as of the same day.

If the tender offer is completed successfully, then the shares of AMPAC which were not tendered will be acquired in a second-step merger at the same cash price per share paid in the tender offer. Completion of the transaction is subject to, among other things, customary closing conditions contained in the definitive merger agreement.

The AMPAC Board of Directors unanimously approved the transaction and recommends that AMPAC stockholders tender their shares in the tender offer.

KeyBanc Capital Markets Inc. is acting as financial advisor, and Morrison & Foerster LLP is acting as legal advisor, to AMPAC. Morgan Stanley & Co., LLC is acting as financial advisor, and Munger, Tolles & Olson LLP is acting as legal advisor, to the independent Transaction Committee of AMPAC’s Board of Directors.  Ropes & Gray LLP is acting as legal advisor to H.I.G.

For further information regarding the terms and conditions contained in the definitive merger agreement, please see AMPAC’s Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission (“SEC”) in connection with this transaction.

ABOUT AMERICAN PACIFIC CORPORATION

American Pacific Corporation is a leading custom manufacturer of fine chemicals and specialty chemicals within its focused markets. AMPAC supplies active pharmaceutical ingredients and advanced intermediates to the pharmaceutical industry. For the aerospace and defense industry, it provides specialty chemicals used in solid rocket motors for space launch and military missiles. AMPAC produces clean agent chemicals for the fire protection industry, as well as electro-chemical equipment for the water treatment industry. AMPAC’s products are designed to meet customer specifications and often must meet certain governmental and regulatory approvals. Additional information about AMPAC can be obtained by visit its web site at www.apfc.com.

ABOUT H.I.G.

H.I.G. is a leading global private equity investment firm with more than $13 billion of equity capital under management.  Based in Miami, and with offices in Atlanta, Boston, Chicago, Dallas, New York, and San Francisco in the U.S., as well as international affiliate offices in London, Hamburg, Madrid, Paris, and Rio de Janeiro, H.I.G. specializes in providing capital to small and medium-sized companies with attractive growth potential.  H.I.G. invests in management-led buyouts and recapitalizations of profitable and well managed manufacturing or service businesses.  Since its founding in 1993, H.I.G. has invested in and managed more than 200 companies worldwide.  The firm’s current portfolio includes more than 50 companies. For more information, please refer to the H.I.G. website at www.higcapital.com.

IMPORTANT INFORMATION AND WHERE TO FIND IT

The tender offer for the outstanding common stock of AMPAC referred to in this press release has not yet commenced. This press release is not an offer to purchase or a solicitation of an offer to sell shares of AMPAC’s common stock. The solicitation and the offer to purchase shares of AMPAC’s common stock will only be made pursuant to an offer to purchase and related materials that H.I.G. intends to file with the SEC. At the time the tender offer is commenced, an affiliate of H.I.G. will file a Tender Offer Statement on Schedule TO with the SEC, and at the same time or soon thereafter AMPAC will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. STOCKHOLDERS OF AMPAC ARE ADVISED TO READ THE SCHEDULE TO (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

Investors and stockholders may obtain free copies of the Schedule TO and Schedule 14D-9, as each may be amended or supplemented from time to time, and other documents filed by the parties (when available), at the SEC’s web site at www.sec.gov. In addition, the tender offer statement on Schedule TO and related offering materials may be obtained for free (when they become available) from H.I.G.

FORWARD-LOOKING STATEMENTS OR INFORMATION

Certain statements in this press release constitute “Forward-Looking Statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act.

Such statements are typically punctuated by words or phrases such as “anticipate,” “estimate,” “should,” “may” and words or phrases of similar import.  These forward-looking statements include statements regarding expectations as to the completion of the tender offer, the merger and the other transactions contemplated by the definitive merger agreement.  The forward-looking statements contained herein involve risks and uncertainties that could cause actual results to differ materially from those referred to in the forward-looking statements. Such risks include, but are not limited to, the ability of the parties to the definitive merger agreement to satisfy the conditions to closing specified in the definitive merger agreement. More information about the Company and other risks related to the Company are detailed in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended September 30, 2013 filed with the SEC.  The Company does not undertake an obligation to update forward-looking statements.

Contact:  Investor Relations – (702) 735-2200
E-mail:  InvestorRelations@apfc.com
Website:  www.apfc.com

Friday, January 10th, 2014 Uncategorized Comments Off on (APFC) To Be Acquired By H.I.G.

(RTRX) Announces Pricing of Public Offering of Common Shares

Retrophin, Inc. (NASDAQ:RTRX) (formerly OTCQB:RTRX) today announced the pricing of an underwritten public offering of 4,705,882 shares of its common stock, offered at a price of $8.50 per share. The gross proceeds from this offering, before underwriting discounts and commissions and other offering expenses, are expected to be approximately $40,000,000. The offering is expected to close on or about January 15, 2014, subject to customary closing conditions. Retrophin also granted the underwriter a 30-day option to purchase 705,882 additional shares of its common stock.

In connection with this offering, the Company received approval to list its common stock on the NASDAQ Global Market under the ticker symbol “RTRX.”

All of the shares sold in the offering are being sold by Retrophin, with the proceeds to be used to obtain regulatory approval for the reintroduction of Syntocinon into the US market for aiding milk letdown, to initiate clinical trials of Retrophin’s product candidates, including Syntocinon for the treatment of Schizophrenia and Autism Spectrum Disorders, RE-034 for the treatment of Infantile Spasms and Nephrotic Syndrome, RE-024 for the treatment of Pantothenate Kinase Associated Neurodegeneration, and sparsentan for the treatment of Focal Segmental Glomerulosclerosis. Any remaining net proceeds will be used for the further advancement of Retrophin’s early stage development programs, for further product development and for general corporate purposes.

Jefferies LLC is acting as sole book-running manager for the offering. Roth Capital Partners, Ladenburg Thalmann & Co. Inc. and Summer Street Research Partners are acting as co-managers.

A registration statement relating to the shares of Retrophin common stock being offered has been filed with, and declared effective by, the Securities and Exchange Commission (the “SEC”). A prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the prospectus, when available, may be obtained from Jefferies LLC, Attention: Syndicate Prospectus Department, 520 Madison Avenue, New York, NY, 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Retrophin

Retrophin is a pharmaceutical company focused on the development, acquisition and commercialization of drugs for the treatment of serious, catastrophic or rare diseases for which there are currently no viable options for patients. The Company’s pipeline includes compounds for several catastrophic diseases, including Focal Segmental Glomerulosclerosis (FSGS), Pantothenate Kinase-Associated Neurodegeneration (PKAN), Duchenne Muscular Dystrophy and others.

Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect the Company’s business. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company’s filings with the Securities and Exchange Commission.

Friday, January 10th, 2014 Uncategorized Comments Off on (RTRX) Announces Pricing of Public Offering of Common Shares

(HOTR) Appoints Mark Allison as SVP Culinary and Kitchen Operations

CHARLOTTE, NC–(January 10, 2014) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (Chanticleer Holdings, or the “Company”), headquartered in Charlotte, North Carolina, announced today that the Company has appointed Mark Allison, international chef and educator, as SVP Culinary and Kitchen. Allison has worked around the world in culinary arts for 34 years.

Mark Allison, a native to England, moved to the U.S. in 2004 from West Glamorgan, Wales, UK, where he was a senior catering lecturer at Neath Port Talbot College where he achieved fame winning Restaurant Magazines best College Restaurant in “Wales and the South West of England” competition in 2004 and was personally honored by Prime Minister Tony Blair for his dedication to the Education and Hospitality field in Wales in 2003.

Since his move to the U.S. in 2004, Mark has been the dean of Culinary Arts Education at Johnson & Wales University, one of America’s most highly regarded culinary arts schools located in Charlotte, NC. He implemented, directed and evaluated culinary planned strategies and tactics related to the college of culinary arts, providing leadership and inspiration to over 40 faculty members, 20 staff and 1400 students.

Allison is the author of “150 Projects to Get You into Culinary Arts,” the ultimate guide for any student aiming to become a chef. He has also received numerous honors and awards including 2011 JWU Publishing Award, 2009 JWU Community Service Award, 2008 JWU “Teacher of the Year Award,” and in 2006 the JWU “Outstanding Service Award.”

“I’m extremely excited to been involved with a company that has such strong leadership and a positive vision for the future. Its diverse culinary operations in the U.S. and around the world will make my position extremely interesting, as we strive to deliver the best possible combination of quality food, service and customer satisfaction in a friendly and competitively priced environment,” commented Mark Allison.

“I first met Mark while he was dean of the culinary school at Johnson and Wales, a very impressive campus and valued resource to the Charlotte community. When the opportunity presented itself to have Mark join Chanticleer in the newly created position, I quickly jumped at it,” commented Mike Pruitt, Chairman and Chief Executive Officer. “As we continue to develop, enhance and grow our restaurant concepts having Mark’s skills and knowledge in a key leadership role will be instrumental to achieving our goals. He will work closely with each of our business units to enhance the customer experience.”

About Chanticleer Holdings, Inc
Headquartered in a Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including England, South Africa, Hungary, and Brazil and has joint ventured with the current Hooters franchisee in Australia. Chanticleer is evaluating several additional international opportunities. The Company also owns and operates American Roadside Burgers and owns a majority interest in Just Fresh restaurants in the U.S.

For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts

Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Press Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com

Friday, January 10th, 2014 Uncategorized Comments Off on (HOTR) Appoints Mark Allison as SVP Culinary and Kitchen Operations

(IMMU) Starts Phase III Clinical Trial of Clivatuzumab Tetraxetan in Pancreatic Cancer

MORRIS PLAINS, N.J., Jan. 9, 2014  — Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced first patient dosing in the Company’s Phase III registration study of its pancreatic cancer drug, yttrium-90 (90Y)-clivatuzumab tetraxetan.

The PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is a double-blind, randomized study aimed to evaluate the safety and efficacy of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care in patients with metastatic pancreatic cancer who have received at least two prior therapies, one of which must have been a gemcitabine-containing regimen. The primary endpoint of this study is overall survival (OS).

In a recently completed Phase Ib clinical trial in the same patient population with relapsed pancreatic cancer, the combination of 90Y-clivatuzumab tetraxetan and low-dose gemcitabine produced a median OS of 4.0 months (6 of 27 subjects were alive 9 months after first dose) with a manageable safety profile. That was statistically significant (p = 0.021) compared to the median OS of 2.8 months when patients were treated with 90Y-clivatuzumab tetraxetan alone. Additionally, there were 2 partial responders in the combination arm. More importantly, the rapid enrollment of the Phase Ib study demonstrated an unmet medical need for treatment options for patients in this late-stage setting.

“This is a major milestone for the Company and for the clinical development of 90Y-clivatuzumab tetraxetan,” remarked Cynthia L. Sullivan, President and Chief Executive Officer. “If the results from the Phase Ib study are confirmed by the PANCRIT-1 trial, clivatuzumab tetraxetan could become the first antibody-directed radiation therapy approved to treat patients with solid tumors. We plan to complete patient accrual in the first half of 2015,” Ms. Sullivan added.

About PANCRIT-1

The PANCRIT-1 trial was designed to enroll approximately 440 patients with metastatic pancreatic cancer. A majority of these patients will be recruited at clinical trial sites across the U.S., with additional sites in Canada, Europe and Israel participating. Eligible patients will be randomized 2 to 1 to the treatment arm of 3 doses of 90Y-clivatuzumab tetraxetan plus 4 doses of gemcitabine at 200 mg/m2 per cycle or placebo plus low-dose gemcitabine. All patients will receive best supportive care. Treatments are administered during the initial 4 weeks of each 7-week cycle, and may be repeated up to a maximum of 6 cycles.

About Clivatuzumab Tetraxetan

Clivatuzumab tetraxetan contains a humanized, highly specific antibody that targets a mucin antigen found on pancreatic cancer cells, and is conjugated to a linker that facilitates complexing with radiometals. This mucin has been found by tissue staining to be present on about 85% of pancreatic cancers but is not found on normal pancreas or tissue from patients with pancreatitis. When the antibody-linker complex is radiolabeled with yttrium-90, this enables delivery of high intensity, deep penetrating radiation directly to the pancreatic tumor cells and the addition of gemcitabine acts as a radiosensitizer to increase the anti-tumor activity. 90Y-clivatuzumab tetraxetan has received Orphan Drug designation in both the U.S. and Europe, and fast track designation in the U.S. for the treatment of patients with pancreatic cancer.

In earlier clinical trials, 90Y-clivatuzumab tetraxetan has produced encouraging results in combination with gemcitabine in newly-diagnosed pancreatic cancer patients or alone in the relapsed population.1,2

About Pancreatic Cancer

According to the American Cancer Society, an estimated 45,220 Americans were diagnosed with pancreatic cancer in 2013, making it the 10th most common cancer diagnosis among men and the 9th most common among women in the U.S. It is, however, the fourth leading cause of cancer death among both men and women nationwide, with approximately 38,460 deaths expected, or about 7% of all cancer deaths.

Currently, only 2 percent of patients diagnosed with pancreatic cancer are alive 5 years later. Gemcitabine alone or in combination with Tarceva or Abraxane are the only FDA-approved front-line treatments for patients with late-stage pancreatic cancer. There are no FDA-approved therapies for patients that relapse and there are few treatment options available.

References

  1. Ocean A.J., Pennington K.L., Guarino M.J. et al. Fractionated radioimmunotherapy with 90Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A Phase I trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.
  2. Gulec S.A., Cohen S.J., Pennington K.L. et al. Treatment of advanced pancreatic carcinoma with 90Y-clivatuzumab tetraxetan: a Phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. Our lead product candidate, epratuzumab, is currently in two Phase III clinical trials in lupus. In oncology, clivatuzumab tetraxetan labeled with a radioisotope is in a Phase III pivotal trial in advanced pancreatic cancer patients. Other solid tumor therapeutics in Phase II clinical development include 2 antibody-drug conjugates, IMMU-132 (anti-TROP-2-SN-38) and IMMU-130 (anti-CEACAM5-SN-38). We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and multifunctional antibodies. DNL™ is being used particularly to make bispecific antibodies targeting cancers and infectious diseases as a T-cell redirecting immunotherapy, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies. We believe that our portfolio of intellectual property, which includes approximately 242 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. Our strength in intellectual property has resulted in the top-10 ranking in the 2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and Pharmaceuticals category. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company’s control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com
Thursday, January 9th, 2014 Uncategorized Comments Off on (IMMU) Starts Phase III Clinical Trial of Clivatuzumab Tetraxetan in Pancreatic Cancer

(CRDC) Receives 510(k) Clearance For MicroCutter XCHANGE™

REDWOOD CITY, Calif., Jan. 9, 2014  — Cardica, Inc. (Nasdaq: CRDC) today announced it obtained 510(k) clearance of the MicroCutter XCHANGE™ 30 device and blue staple cartridge for medium thickness tissue from the U.S. Food and Drug Administration for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The XCHANGE 30 is the smallest diameter cutting and stapling device available today, with articulation up to 80 degrees and single-handed operation.

“We are extremely pleased to achieve this important corporate milestone, allowing us to market the MicroCutter XCHANGE 30 in the United States,” said Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. “We have been working with leading European surgeons in a commercial setting over the past year to optimize this device for use in both open and laparoscopic procedures. We look forward to implementing a selective commercial launch in the United States in the months ahead to address the growing need for a smaller surgical stapling device. Looking beyond the initial introduction, we plan to submit our 510(k) premarket notification for the white stapling cartridge for thin tissue and blood vessels also used with the XCHANGE 30 device, in the current quarter, to further expand the device’s applicability in surgical procedures.”

The clearance of the XCHANGE 30 and the blue stapling cartridge for medium thickness tissue is based on data submitted from Cardica’s European clinical trial to evaluate the XCHANGE 30 in a variety of gastrointestinal surgical procedures. The XCHANGE 30, with a 5-millimeter shaft diameter, met the primary endpoint of non-inferiority to a 12-millimeter stapler, with only one device-related event in 160 enrolled patients with 423 deployments.

“Over the course of the last decade, surgical tool size has trended down substantially to allow for less invasive surgical procedures with better patient outcomes,” said Juan-Carlos Verdeja, M.D., F.A.C.S., associate professor of surgery and director of laparoscopy and minimally invasive surgery at Florida International University Herbert Wertheim College of Medicine. “The MicroCutter XCHANGE 30 meets the need for increasingly smaller surgical tools, and provides a significant and needed innovation. This device can now be used with a smaller trocar, particularly important during surgical procedures where multiple angles are helpful for an approach to an organ.”

The MicroCutter XCHANGE 30 is a cartridge-based, minimally-invasive stapling system with a 5-millimeter shaft diameter and cross sectional area significantly smaller than 12-millimeter conventional staplers, and with greater articulation. The size and degree of articulation enhances the surgeon’s access and visualization at the surgical site. Combining several new technologies, this device is designed to mitigate limitations on surgical procedures created by larger stapling devices. As the smallest profile stapler available today, the device may reduce the amount of tissue dissection and handling to get the stapler in proper position to fire. The XCHANGE 30 uses reloadable cartridges with a 30mm staple line length and an integrated knife and is currently indicated to fire up to six times per device.

About Cardica 
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica’s technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its MicroCutter XCHANGE™ 30, a cartridge-based surgical stapling device with a five-millimeter shaft diameter, for use in a variety of gastrointestinal procedures and appendectomies in the United States and a wide range of surgical procedures in Europe. Cardica is developing the Cardica® MicroCutter XCHANGE™ 45, a cartridge-based microcutter device with an eight-millimeter shaft to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 45 product requires 510(k) review and CE Mark and is not yet commercially available in the U.S. or internationally. In addition, Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 47,700 units throughout the world.

Forward-Looking Statements
The statements in this press release regarding Cardica’s intent to implement a selective commercial launch of the XCHANGE 30 in the United States in the months ahead and to submit a 510(k) clearance application for its white stapling cartridge in the current quarter are “forward-looking statements.” There are a number of important factors that could cause Cardica’s results to differ materially from those indicated by these forward-looking statements, including: that Cardica may not be successful in its efforts to commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that the XCHANGE 30 may face unanticipated development, regulatory, or manufacturing delays; that the timing of 510(k) applications and receipt of clearance for such applications may be delayed by unanticipated events, as well as other risks detailed from time to time in Cardica’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, under the caption “Risk Factors.” Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardica’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.

SOURCE Cardica, Inc.

Thursday, January 9th, 2014 Uncategorized Comments Off on (CRDC) Receives 510(k) Clearance For MicroCutter XCHANGE™

(SGMO) and Biogen Idec Global Collaboration for Hemoglobinopathies Treatments

–Partnership to Focus on Developing Novel Therapies for Sickle Cell Disease and Beta-Thalassemia–

CAMBRIDGE, Mass. and RICHMOND, Calif., Jan. 9, 2014  — Biogen Idec (NASDAQ:BIIB) and Sangamo BioSciences, Inc. (NASDAQ: SGMO) announced today an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies, inherited conditions that result from the abnormal structure or underproduction of hemoglobin. The agreement will enable Biogen Idec to further enhance its expertise in non-malignant hematology by leveraging Sangamo’s proprietary genome-editing technology platform to develop treatments targeting sickle cell disease (SCD) and beta-thalassemia.

(Logo:  http://photos.prnewswire.com/prnh/20140109/SF43275LOGO)

(Logo: http://photos.prnewswire.com/prnh/20130102/SF35903LOGO)

“Our collaboration with Sangamo is expected to help us expand our capabilities to develop treatments for people with serious, inherited hematologic conditions,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of research and development. “Building upon emerging science related to fetal hemoglobin regulation, we intend to develop Sangamo’s novel gene-editing technology to create a single approach that has the potential to functionally cure both sickle cell disease and beta-thalassemia.”

Sangamo’s proprietary zinc finger nuclease (ZFN) genome-editing technology enables multiple pathways to treat SCD and beta-thalassemia. The technology can be used to precisely target and knock out key regulators of gene expression, or can be used to precisely insert a new corrective gene to replace the defective copy.

“We are delighted to partner our hemoglobinopathies programs with Biogen Idec,” said Edward Lanphier, Sangamo’s president and chief executive officer. “Biogen Idec is a leader in drug development and has a history of successfully translating cutting edge science into treatments that provide life-changing clinical benefit for patients. This alliance is further validation of our ZFP platform as a transformative technology and accelerates our goal of developing a novel class of therapeutics which has the potential to revolutionize the treatment of genetic diseases.”

Under the terms of the agreement, Sangamo is responsible for all research and development activities through the first clinical proof of concept trial in beta-thalassemia, and both companies will perform activities to enable submission of an Investigational New Drug (IND) application for SCD. Biogen Idec will be responsible for subsequent worldwide clinical development and commercialization of products arising from the alliance. Sangamo retains an option to co-promote any licensed product to treat SCD and beta-thalassemia in the United States.

Biogen Idec will provide Sangamo with an upfront payment of $20 million and will reimburse Sangamo for its internal and external research and development program-related costs. Sangamo may also receive additional payments of approximately $300 million based on the achievement of certain development, regulatory, commercialization and sales milestones, as well as double digit royalties on product sales.

The transaction has been approved by the boards of directors of both companies and is subject to customary closing conditions including expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the United States.

About Sangamo’s ZFN Therapeutic Approach to Hemoglobinopathies

Sangamo’s proprietary ZFN genome-editing technology enables multiple approaches to the correction of SCD and beta-thalassemia. Both diseases manifest after birth, when patients switch from producing functional fetal gamma-globin to a mutant form of adult beta-globin, which results in their condition. Naturally occurring increased levels of therapeutic fetal hemoglobin have been shown to reduce the severity of both SCD and beta-thalassemia disorders in adulthood. In hematopoietic stem cells (HSCs), Sangamo’s genome editing can be used to precisely disrupt key transcriptional regulators to reverse the switch from expression of the mutant adult beta-globin back to the production of functional fetal gamma-globin, or the technology can be used to precisely insert a new corrected beta-globin gene to replace the defective copy. Data from this program were recently presented at the 55th Annual Meeting of the American Society of Hematology (ASH).

A bone marrow transplant (BMT), of HSCs from a “matched” related donor (allogeneic BMT) is curative for both diseases. However, this therapy is limited due to the scarcity of matched donors and the significant risk of Graft versus Host Disease (GvHD) after transplantation of the foreign cells. By performing genome editing in HSCs that are isolated from and subsequently returned to the same patient, an autologous HSC transplant, Sangamo’s approach eliminates both the need for a matched donor and the risk of acute and chronic GvHD. The ultimate goal of this approach is to develop a one-time curative treatment for SCD and beta-thalassemia.

In May 2013, Sangamo was awarded a $6.4 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM) to develop this potentially curative ZFP Therapeutic for beta-thalassemia. The four-year grant provides matching funds for preclinical work that will support an IND application and a Phase 1 clinical trial in transfusion-dependent beta-thalassemia patients, which will be carried out at Children’s Hospital & Research Center Oakland, and City of Hope.

About Hemoglobinopathies

Mutations in the genes encoding beta-globin, a subunit of the oxygen-carrying protein of red blood cells, lead to the hemoglobinopathies SCD and beta-thalassemia. The mutation in beta-globin that gives rise to SCD causes the red blood cells to form an abnormal sickle or crescent shape making them adherent, fragile and less able to deliver oxygen to tissues, and they can become lodged in small blood vessels and interrupt healthy blood flow. These problems further decrease the amount of oxygen flowing to body tissues. Almost all patients with SCD have painful episodes (called crises), which can last from hours to days, and have progressive organ damage, resulting in shortened lifespan. Current standard of care is to manage and control symptoms, and to limit the number of crises. Current treatments, including blood transfusions, iron-chelation therapy and administration of hydroxyurea, pain medications and antibiotics, do not address the underlying cause of disease, and life expectancy remains substantially reduced in patients with SCD. The CDC estimates that there are currently 90,000 to 100,000 Americans living with SCD which occurs in approximately 1 out of every 500 African-American births and 1 out of every 36,000 Hispanic-American births.

There are several forms of beta-thalassemia caused by mutations in the beta-globin gene; broadly the disorder results in excessive destruction of red blood cells leading to life-threatening anemia, enlarged spleen, liver and heart, and bone abnormalities. Beta-thalassemia major is a severe form of thalassemia that requires regular, often monthly, blood transfusions and subsequent iron-chelation therapy to treat iron overload. The CDC estimates that 2,000 people have beta-thalassemia in the United States, and an unknown number carry the genetic trait and can pass it on to their children. Thalassemia is most common among people of Mediterranean descent and is also found among people from the Arabian Peninsula, Iran, Africa, Southeast Asia and Southern China.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Sangamo

Sangamo BioSciences, Inc. is focused on research and development of novel DNA-binding proteins for therapeutic gene regulation and genome editing. The company has ongoing Phase 2 and Phase1/2 clinical trials to evaluate the safety and efficacy of a novel ZFP Therapeutic® for the treatment of HIV/AIDS. As part of its acquisition of Ceregene Inc., Sangamo acquired a fully-enrolled and funded, double-blind, placebo-controlled Phase 2 trial to evaluate NGF-AAV (CERE-110) in Alzheimer’s disease. Sangamo’s other therapeutic programs are focused on monogenic diseases, including hemophilia, Huntington’s disease and hemoglobinopathies such as sickle cell disease and beta-thalassemia. Sangamo’s core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs).Engineering of ZFPs that recognize a specific DNA sequence enables the creation of sequence-specific ZFP Nucleases (ZFNs) for gene modification and ZFP transcription factors (ZFP TFs) that can control gene expression and, consequently, cell function. Sangamo has entered into a strategic collaboration with Shire AG to develop therapeutics for hemophilia, Huntington’s disease and other monogenic diseases and has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website at www.sangamo.com. ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.

Biogen Idec Safe Harbor Statement

This press release contains forward-looking statements, including statements about Biogen Idec’s expectations and goals to develop treatments for people with serious, inherited hematologic conditions, including sickle cell disease and beta-thalassemia, through its collaboration with Sangamo. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty inherent in the regulatory review process and satisfaction of the other closing conditions of the transaction, risks and uncertainties associated with drug development and commercialization, Biogen Idec’s dependence on third parties over which it may not always have full control, and the other risks and uncertainties that are described in the Risk Factors section of Biogen Idec’s most recent annual or quarterly report filed with the Securities and Exchange Commission.These statements are based on current beliefs and expectations and speak only as of the date of this press release. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.

Sangamo Safe Harbor Statement

This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFNs, potential therapeutic applications of the ZFN technology for the treatment of hemoglobinopathies, SCD and beta-thalassemia and potential milestone, royalty and other payments under the collaboration agreement. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties and risks relating to clinical trials, compliance with regulatory and other requirements, the ability of Sangamo to develop commercially viable products and technological developments by our competitors. See the SEC filings, and in particular, the risk factors described in Sangamo’s Annual Reports on Form 10-K and most recent Quarterly Reports on Form 10-Q. Sangamo does not assume any obligation to update the forward-looking information contained in this press release.

MEDIA CONTACTS:Biogen Idec

Todd Cooper

Corporate Communications, Public Affairs

Ph: (781) 464-3260

Sangamo BioSciencesElizabeth Wolffe, Ph.D.

ewolffe@sangamo.com

Ph: (510) 970-6000, x271

INVESTOR CONTACTS:Biogen Idec

Carlo Tanzi, Ph.D.

Director, Investor Relations

Ph: (781) 464-2442

Sangamo BioSciencesElizabeth Wolffe, Ph.D.

ewolffe@sangamo.com

Ph: (510) 970-6000, x271

Thursday, January 9th, 2014 Uncategorized Comments Off on (SGMO) and Biogen Idec Global Collaboration for Hemoglobinopathies Treatments

(ICPT) 2013 Year-End Update and 2014 Anticipated Milestones

NEW YORK, Jan. 9, 2014 — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), today provided a clinical update on obeticholic acid (OCA), a novel bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR), currently being developed in a Phase 3 trial for primary biliary cirrhosis (PBC), as well as Phase 2 trials for several chronic indications including nonalcoholic steatohepatitis (NASH), portal hypertension and bile acid diarrhea (BAD), together with projected 2014 anticipated milestones. Intercept will hold a conference call and audio webcast today at 4:30 p.m. ET to review this information with details provided below.

“2013 was an important year for Intercept as we continued to advance OCA in PBC, NASH and other indications with promising clinical data suggesting that, in keeping with its potent FXR agonist properties, OCA could potentially be used to treat a number of chronic liver and intestinal diseases,” said Mark Pruzanski, M.D., Chief Executive Officer of Intercept. “We recently finished the double-blind phase of our Phase 3 POISE trial in PBC and are happy to see that a vast majority of the patients completing the 12 months have opted to cross over to the five year long term safety extension open-label phase of the trial. Together with the FLINT results announced earlier today, Intercept has obtained positive clinical data in all six Phase 2 clinical trials completed to date in five different indications. We’re looking forward to a pivotal year in 2014, with clinical data awaited from POISE and FLINT, followed by the anticipated completion of the NDA and MAA filings for PBC by year end.”

Summary of Recent Program Updates and 2014 Anticipated Milestones

— PBC Program:

  • POISE Double-Blind Phase Completed; Top-line Results Expected in 2Q 2014
  • More than 95% Enrollment into Long-Term Safety Extension of POISE Trial
  • Supergroup Final Data Support Utility of POISE Surrogate Endpoint; Phase 3 Confirmatory Trial to be Initiated in 2Q 2014
  • NDA and MAA Filings for OCA in PBC Anticipated End of 2014

— Proof of Concept Trials in Portal Hypertension (PESTO) and Bile Acid Diarrhea (OBADIAH) Completed; Double-Blind Phase 2b Trial in Each Indication to be Initiated in 2H 2014

— Double-Blind Phase 2 Trial to be Initiated in Primary Sclerosing Cholangitis in 2H 2014

— Phase 1 Trial for INT-767, Dual FXR and TGR5 Agonist, to be Initiated in 4Q 2014

POISE: Phase 3 Trial in Primary Biliary Cirrhosis

Double-Blind Phase Completed with Strong Enrollment into Long-Term Safety Extension Phase

POISE is a double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of a once daily dose of OCA in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol. In December 2013, the last patient follow-up visit was completed, marking the conclusion of the double-blind phase of the POISE trial. Of the 217 patients randomized, 19 patients (approximately 9%) discontinued early, including seven patients (approximately 3%) who did so due to pruritus. Top-line results from the double-blind phase of the POISE trial are expected to be available in the second quarter of 2014.

Patients completing the double-blind phase have had the option to continue in an open-label, long-term safety extension (LTSE) phase for another five years, during which all patients will receive OCA treatment with daily doses starting at 5 mg and potentially titrating up to 25 mg a day, as clinically indicated. Of the 198 patients who completed the double-blind phase, more than 95% continued in the LTSE phase of the trial.

Global PBC Study Group (Supergroup)

Data from over 6,100 PBC patients collected and pooled by an independent group of 15 academic medical centers across eight countries have been analyzed by the Global PBC Study Group, or Supergroup, and key data were presented at the 2013 AASLD conference by the Supergroup. These and additional analyses confirm that the surrogate biochemical endpoint used in POISE (i.e., alkaline phosphatase (ALP) < 1.67x upper limit of normal (ULN) and normal bilirubin) is strongly predictive of clinical outcomes in PBC patients. Specifically, the analyses demonstrated that patients who failed to meet the POISE trial primary endpoint after one year of ursodeoxycholic acid (UDCA) treatment had approximately two times greater chance of dying or requiring a liver transplant.

Based on these additional analyses, Intercept has submitted a design for its anticipated confirmatory trial to FDA for review. If subsequent discussions result in general agreement concerning the appropriate design of the trial without undue delay, Intercept intends to initiate the confirmatory trial in the second quarter of 2014.

PESTO: Phase 2a Trial in Portal Hypertension

Recently Completed Open-Label Trial Supports Initiation of Double-Blind Trial in Portal Hypertension

PESTO is an open-label, multi-center Phase 2a trial evaluating the safety and efficacy of OCA administered to alcoholic cirrhotic patients for approximately seven days at daily doses of 10 mg and 25 mg for the treatment of portal hypertension. The rationale for the PESTO trial is based on previously published results in animal models of cirrhosis, demonstrating that short term OCA therapy can reverse portal hypertension via a local nitric oxide induced mechanism with no concomitant change in systemic blood pressure.

Preliminary data from PESTO indicate that approximately 50% of patients evaluated for efficacy in the combined dose groups demonstrated a clinically significant reduction in hepatic venous pressure gradient (HVPG) reflective of a lowered risk of variceal bleeds. Systemic mean arterial blood pressure, already adversely low in cirrhotic patients, was unchanged at the end of therapy.

Detailed results obtained by the lead investigator, Raj Mookerjee, M.D., at the primary center (University College London) conducting the PESTO trial have been submitted for presentation at the upcoming International Liver Congress of the European Association for the Study of the Liver (EASL) in April 2014.

Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2b clinical trial focusing on HVPG as an endpoint in patients with liver cirrhosis and portal hypertension in the second half of 2014.

OBADIAH: Phase 2a Trial in Primary and Secondary Bile Acid Diarrhea

Recently Completed Open-Label Trial Supports Initiation of Double-Blind Trial in Secondary BAD

OBADIAH is an investigator-initiated open-label Phase 2a trial evaluating the safety and efficacy of OCA in the treatment of primary and secondary bile acid diarrhea, with Professor Julian Walters at Imperial College London acting as Principal Investigator. The trial demonstrated that OCA increased levels of fibroblast growth factor 19 (FGF19) with concomitant clinical improvement over a two-week treatment period in patients with primary BAD (pBAD) and in patients with secondary bile acid diarrhea due to Crohn’s disease (sBAD), with no response shown in a control group consisting of IBS-D patients with normal FGF19 levels. The data also show that increased length of prior ileal resection reduced response to OCA treatment in Crohn’s patients suffering from sBAD.

Detailed results from OBADIAH have been submitted for presentation at Digestive Disease Week in May 2014. Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2b clinical trial of OCA in Crohn’s patients with sBAD in the second half of 2014.

Phase 2 Trial in Primary Sclerosing Cholangitis

Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2 clinical trial of OCA in primary sclerosing cholangitis (PSC) in the second half of 2014. PSC is a chronic autoimmune liver disease that could eventually lead to cirrhosis, liver failure and death. As with PBC, studies have shown that patients with PSC who have reduced or normal levels of ALP have significantly improved long-term clinical outcomes. Although there is no approved treatment of PSC, patients are commonly treated with ursodiol. The prevalence of PSC is estimated to be approximately one-third that of PBC, with approximately 60% of cases occurring in men and typically 75% of PSC patients also having associated ulcerative colitis.

Phase 1 Trial of INT-767

INT-767 is an orally-administered dual FXR and TGR5 agonist that, similar to OCA, is derived from the primary human bile acid chenodeoxycholic acid (CDCA). This product has been tested in numerous animal models of chronic liver, intestinal and kidney diseases and has demonstrated preclinically potent anti-fibrotic and anti-inflammatory properties. Intercept is completing IND-enabling studies for INT-767, with the intention to submit an IND and initiate Phase 1 trials in the fourth quarter of 2014.

Today’s Conference Call and Webcast at 4:30 p.m. ET

Intercept will hold a conference call and audio webcast today at 4:30 p.m. ET. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (domestic) or (315) 625-6894 (international) five minutes prior to the start time. A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver diseases utilizing its expertise in bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. OCA has received orphan drug designation in both the United States and Europe for the treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan and China, where it has out-licensed the product candidate to Dainippon Sumitomo Pharma. For more information about Intercept, please visit the Company’s website at: www.interceptpharma.com.

Safe Harbor Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements regarding the Company’s anticipated outlook and milestones for 2014; potential application of OCA in liver, gastrointestinal and other indications; relationship between the endpoints being investigated and adverse clinical outcomes in the related indication; the clinical utility of the selected endpoints and any potential consensus relating thereto; the acceptance by regulatory authorities of the trial endpoint or results; clinical, preclinical and regulatory developments for our product candidates; the anticipated timeframe for the commencement, completion and receipt of results from Intercept’s clinical trials and for the making of regulatory submissions; the anticipated results of our clinical and preclinical trials and other development activities; and our strategic directives under the caption “About Intercept.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of Intercept’s development activities, preclinical studies and clinical trials; the timing of and Intercept’s ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates it may develop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; Intercept’s plans to research, develop and commercialize future product candidates; the election by Intercept’s collaborators to pursue research, development and commercialization activities; Intercept’s ability to attract collaborators with development, regulatory and commercialization expertise; Intercept’s ability to obtain and maintain intellectual property protection for its product candidates; Intercept’s ability to successfully commercialize its product candidates; the size and growth of the markets for Intercept’s product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept’s ability to obtain additional financing; Intercept’s use of the proceeds from its initial public offering in October 2012 and follow-on offering in June 2013; the accuracy of Intercept’s estimates regarding expenses, future revenues, capital requirements and the need for additional financing; the loss of key scientific or management personnel; and other factors discussed under the heading “Risk Factors” contained in Intercept’s annual report on Form 10-K for the year ended December 31, 2012 filed on April 1, 2013 as well as any updates to these risk factors filed from time to time in Intercept’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.

CONTACT: Barbara Duncan or Senthil Sundaram
         Intercept Pharmaceuticals
         1-646-747-1000
Thursday, January 9th, 2014 Uncategorized Comments Off on (ICPT) 2013 Year-End Update and 2014 Anticipated Milestones

(VNRX) Presents at MicroCapClub Invitational

Company Invites Investors to View Presentation

NAMUR, BELGIUM–(Jan 9, 2014) –  VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, announced today it has been selected to present at the 2nd annual MicroCapClub Invitational.

The presentation can be accessed at the following link: http://microcapclub.com/2014/01/microcapclub-invitational-volitionrx-vnrx/

“At MicroCapClub we have 147 experienced microcap investors discussing over 180 microcap companies in our members forum. We handpick several unique companies every year to showcase to the public,” said Ian Cassel, founder of MicroCapClub. “We have been following VolitionRx since it went public a couple years ago and believe the company is now at an interesting inflection point. If the company’s blood based cancer diagnostic platform is successfully validated through large clinical trials in 2014, it will be a game changer for the cancer arena and shareholders. Given the company’s current valuation compared to its peer group, we feel VolitionRx is worth following.”

“We have an exciting year coming up,” says Cameron Reynolds, CEO of VolitionRx. “On the clinical side, we expect to publish initial results from our first major 4,800-individual colorectal cancer diagnostic trial, and begin the application process for European CE regulatory approval. We also expect to book significant early revenue from our epigenetic Research Use Kits, which will assist the company in funding our ongoing trials.”

About MicroCapClub
Founded in 2011, MicroCapClub is an exclusive forum for experienced microcap investors focused on microcap companies (sub $300m market cap). MicroCapClub was created to be a platform for experienced microcap investors to share and discuss stock ideas. MicroCapClub’s mission is to foster the highest quality microcap investor Community, produce Educational content for investors, and promote better Leadership in the microcap arena. For more information, visit www.MicroCapClub.com.

About VolitionRx
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream — an indication that cancer is present.

VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests.

Visit Volition’s website http://www.volitionrx.com or connect with us via Twitter (VolitionRx and VNRXInvestors), LinkedIn or Facebook.

Contact information:
Media Contacts
Charlotte Reynolds
VolitionRx
E: charlotte.reynolds@volitionrx.com
T: +44 7952 177 498

Investor Contacts
Kirin M. Smith
Proactive Capital
E: mksmith@proactivecapital.com
T: +1 646 863 6519

Thursday, January 9th, 2014 Uncategorized Comments Off on (VNRX) Presents at MicroCapClub Invitational

(IPWR) Appoints Global Energy Executive, R. Daniel Brdar, CEO and Chairman of the Board

Paul Bundschuh Assumes Role of President and Chief Commercial Officer

AUSTIN, TX–(Jan 8, 2014) – Ideal Power Inc. (NASDAQ: IPWR), a developer of a disruptive technology in the power conversion industry, today announced that R. Daniel Brdar has been appointed as the Company’s Chief Executive Officer and Chairman of the Board of Directors, effective January 8, 2014. Paul Bundschuh will assume the role of President and Chief Commercial Officer.

“We are delighted that Dan has accepted the position of Chairman and CEO. He brings a deep understanding of the power generation and power electronics markets and an impressive track record of building world-class, cross-functional teams, developing innovative products, expanding into global markets, and driving meaningful growth in early-stage companies,” commented Mr. Bundschuh. “We continue to make progress in positioning and commercializing our disruptive Power Packet Switching Architecture™ for the power converter markets. Dan will be instrumental in leading us in our next stage of growth and in helping us attain a competitive position in the fast-growing renewable energy, grid storage and other green technology markets both in the U.S. and internationally.”

Mr. Brdar has over 25 years of experience in the power systems and energy industries and has held a variety of leadership positions during his career. From 2006 through 2011, he was President and CEO of FuelCell Energy Inc., a NASDAQ-listed company with a market cap of over $250 million. During his tenure, the company’s revenues increased 235%, to $100 million, manufacturing production increased by over 200% and over $100 million was raised from institutional and strategic investors. Prior to joining Ideal Power Inc., Mr. Brdar served as the Chief Operating Officer of Petra Solar, a privately held, venture funded solar and smart grid company, where he held full P&L responsibility and led a cross-functional management team across several international markets. From 1997 to 2000, Mr. Brdar held management positions, including Gas Turbine Product Manager, for GE’s Power Systems Division, a world leader in power generation systems and products. Additionally, Mr. Brdar has extensive research and development experience at the U.S. Department of Energy through various roles at the National Energy Technology Laboratory in Morgantown, WV and Pittsburgh, PA. Mr. Brdar has a BS in Engineering from the University of Pittsburgh.

“I am thrilled to have the opportunity to lead Ideal Power into its next exciting phase,” said Mr. Brdar. “I believe that Ideal Power’s power conversion architecture is one of the most innovative and disruptive technologies in the market today and will be a competitive presence in several important emerging markets such as power converters for renewable energy applications, including commercial grid storage. I look forward to working with Ideal Power’s executive team in driving growth for the company and the entire power electronics ecosystem.”

Ideal Power’s Board of Directors unanimously approved the appointment of R. Daniel Brdar as CEO and Chairman.

Inducement Award

In accordance with Section 5635(c)(4) of the rules of the NASDAQ Stock Market and in connection with his appointment, Ideal Power will make a stock option grant to Mr. Brdar pursuant to a stand-alone award agreement outside of the Company’s 2013 Equity Incentive Plan as an inducement material to Mr. Brdar entering into employment with Ideal Power. The inducement grant was approved by the compensation committee of Ideal Power’s Board of Directors, which is comprised solely of independent directors. Mr. Brdar’s inducement grant consists of a stock option to purchase up to 250,000 shares of Ideal Power’s common stock, with a per share exercise price equal to the closing price of the Company’s common stock on January 8, 2014, the date that his employment will begin. Mr. Brdar’s option vests and becomes exercisable in four equal annual installments beginning on the one-year anniversary of the date of grant, subject to his continuous service through each vesting date. The option has a term of 10 years from the date of grant.

About Ideal Power Inc.

Ideal Power Inc. (NASDAQ: IPWR) has developed a novel, patented power conversion technology called Power Packet Switching Architecture™ (PPSA). PPSA improves the size, cost, efficiency, flexibility and reliability of electronic power converters. PPSA can scale across several large and growing markets, including solar photovoltaic generation, electrified vehicle charging, and commercial grid storage. Ideal Power also has a licensing-based, capital-efficient business model that can enable it to address these markets simultaneously. Ideal Power has won multiple grants for its PPSA technology, including a $2.5 million grant from the Department of Energy’s Advanced Research Projects Agency – Energy program, and market-leading customers are incorporating PPSA as a key component of their systems. For more information on Ideal Power, visit www.IdealPower.com.

Safe Harbor Statement

All statements in this release that are not based on historical fact are “forward looking statements”. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, whether the patents for our technology provide adequate protection and whether we can be successful in maintaining, enforcing and defending our patents, whether demand for our products, which we believe are disruptive, will develop and whether we can compete successfully with other manufacturers and suppliers of energy conversion products, both now and in the future, as new products are developed and marketed. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.

Ideal Power Media Contact:
Mercom Communications
Wendy Prabhu
1.512.215.4452
www.mercomcapital.com
Email Contact

Investor Relations Contact:
MZ North America
Matt Hayden
1.949.259.4986
www.mzgroup.us
Email Contact

Wednesday, January 8th, 2014 Uncategorized Comments Off on (IPWR) Appoints Global Energy Executive, R. Daniel Brdar, CEO and Chairman of the Board

(IMRS) Nearly 13,000 patients have benefited from VISIUS iMRI

2014 procedures expected to increase 31% over 8-year total as intraoperative MRI utilization expands to improve outcomes in growing number of neurosurgical applications

MINNEAPOLIS, Jan. 8, 2014  – IMRIS Inc. (NASDAQ: IMRS) (TSX: IM) (“IMRIS” or the “Company”) today announced that an internal study of 40 worldwide VISIUS® Surgical Theatre hospital customers indicates that nearly 13,000 patients have been treated using intraoperative MRI (iMRI) since the first installation in 2005. Four of 27 US hospitals – located in Boston, MA; St. Louis, MO; and Minneapolis and St. Paul, MN – currently using VISIUS iMRI are approaching 1,000 cases performed.

Dr. Frederick Boop, Co-director of the Le Bonheur Neuroscience Institute in Memphis, TN, credits VISIUS iMRI with reducing reoperation rates. “Intraoperative MRI is an important tool in our pediatric program by allowing us to get a more complete removal of these tumors and better overall visualization without moving the patient and knowing we won’t have to bring the patient back for another operation,” he said.

With more installations coming online and procedure numbers growing steadily, IMRIS President and CEO Jay D. Miller said the company estimates the volume will be almost 17,000 by the end of 2014, an increase of roughly 31% in one year over the previous eight years. “With increasing adoption and utilization, more neurosurgeons and hospitals are recognizing the decision support advantage of enhanced visualization in the intraoperative setting and reduced risks associated with not moving patients for imaging,” he said.

“The top neurosurgical hospitals are making the IMRIS solution their standard of care and not only increasing the number of procedures completed in the suite,” Miller added, “but also expanding the types of applications and conditions other than various brain tumors, such as epilepsy, Parkinson’s disease, stroke intervention, aneurysm, and Chiari malformation, and other neurological procedures using deep brain stimulation, ablation and other technologies with iMR. Also, the recent addition of VISIUS iCT expands our solution into spinal conditions, trauma and intricate reconstructions.”

Inside a VISIUS Surgical Theatre equipped with either high-field iMRI or 64-slice intraoperative Computed Tomography (iCT), surgeons have on-demand access to real-time data and state-of-the-art imaging, during the procedure from the operating room (OR) table. IMRIS is the only company that offers an MRI and CT imaging solution where the scanner moves on ceiling-mounted rails to enter or exit the OR which mitigates known risks of moving critically-ill patients.

Unlike other systems, no heavy imaging equipment needs to be wheeled into the room nor does the patient need to be moved to an adjacent imaging room from the OR. The surgeon can visualize, evaluate and confirm results while modifying treatment without case interruption. Developed for neurosurgery and spinal surgery, the systems are also intended to provide physicians with state-of-the-art image quality with access to a full range of software applications.

Surgeons using iMRI for brain tumor removal have reported outcomes of more complete resection1 and reduced pediatric re-operation2 rates. Data published in 2011 showed 93 percent of iMRI glioma cases achieved gross or near total resection compared to 65 percent for non-iMRI cases in the same timeframe.A separate study indicated the need for repeat surgeries decreased with eight percent of non-iMRI patients requiring re-surgery within two weeks post procedure compared to zero re-surgeries for iMRI patients. 2

About IMRIS
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image guided therapy solutions through its VISIUS Surgical Theatre – a revolutionary, multifunctional surgical environment that provides unmatched intraoperative vision to clinicians to assist in decision making and enhance precision in treatment. The multi-room suites incorporate diagnostic quality high-field MR, CT and angio modalities accessed effortlessly in the operating room setting. VISIUS Surgical Theatres serve the neurosurgical, spinal, cardiovascular and cerebrovascular markets and have been selected by 56 leading medical institutions around the world.

References:

  1. Chicoine MR, Lim CCH, Evans JA, Singla A, Zipfel GJ, Rich KM, Dowling JL, Leonard JR, Smyth MD, Santiago P, Leuthardt EC, Limbrick DD, Dacey RG : Implementation and Preliminary Clinical Experience with the Use of Ceiling Mounted Mobile High Field Intraoperative Magnetic Resonance Imaging Between 2 Operating Rooms, ACTA Neurochirgica suppl. 2011;109:97-102.
  2. Shah MN, Leonard JR, et al. Intraoperative magnetic resonance imaging to reduce the rate of early reoperation for lesion resection in pediatric neurosurgery. J Neurosurg Pediatrics. 9:259-264, 2012.

SOURCE IMRIS Inc.

Image with caption: “Hospitals utilizing IMRIS VISIUS intraoperative MRI have completed nearly 13,000 procedures since the initial installation in 2005, including four in the US that expect to reach 1,000 procedures in 2014. (CNW Group/IMRIS Inc.)”.

Wednesday, January 8th, 2014 Uncategorized Comments Off on (IMRS) Nearly 13,000 patients have benefited from VISIUS iMRI

(MNGA) Distributor Signs Development Contract with Italian National Energy Agency

Italian National Alternative Energy Laboratory to Perform Tests on MagneGas

TAMPA, Fla., Jan. 8, 2014  — MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA), the developer of a technology that converts liquid waste into hydrogen-based fuels, announces that its Italian Distributor, “Nuova MagneGas Italia” has signed a contract with the Italian National Alternative Energy Laboratory to perform various tests on MagneGas fuels.

ENEA (http://old.enea.it/com/ingl/) the Italian National Agency for New Technologies, Energy and Sustainable Economic Development, recently signed a contract with Nuova MagneGas Italia to perform testing of the gasification of various feedstocks and certification of internal combustion engine operation. These tests will initiate in February of 2014 and are expected to take 180 days to complete.  Any MagneGas equipment sales in Europe will be sourced from MagneGas Corp in the United States.

“ENEA is seen as one of the leading alternative energy and economic development agencies in Europe with over 500 engineers dedicated to energy and other fields. This development contract will accelerate the validation and acceptance of MagneGas™ fuel at a national and European level,” commented Giovanni Cocchiaro, CEO of MagneGas Italy, Nuova MagneGas Italia.

“ENEA’s United States equivalent would be the National Renewable Energy Laboratory of the Department of Energy so this is a significant development for the validation of the MagneGas technology in Europe and worldwide.  Therefore, the entire MagneGas family is very pleased to have entered into a development contract with ENEA which will be able to validate several applications for Italy and Europe as a whole.  Any equipment sales from Europe will be sourced from the United States, which would have a direct impact on MagneGas,” stated Ermanno Santilli CEO of MagneGas Corp.

The MagneGas IR App is now available for free in Apple’s App Store for the iPhone or iPad http://bit.ly/AfLYww and at Google Play http://bit.ly/Km2iyk for Android mobile devices.

To be added to the MagneGas investor email list, please email pcarlson@kcsa.com with MNGA in the subject line.

About MagneGas Corporation
Founded in 2007, Tampa-based MagneGas Corporation (NASDAQ: MNGA) is the producer of MagneGas, a natural gas alternative and metal working fuel that can be made from certain industrial, municipal, agricultural and military liquid wastes following the receipt of appropriate governmental permits.

The Company’s patented Plasma Arc Flow process gasifies liquid waste, creating a clean burning hydrogen based fuel that is essentially interchangeable with natural gas. MagneGas can be used for metal working, cooking, heating, powering bi fuel automobiles and more. For more information on MagneGas, please visit the Company’s website at www.MagneGas.com.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events, including our ability to raise capital, or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The Company is currently using new ethylene glycol to produce fuel until proper permits to process used liquid waste have been obtained.

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Wednesday, January 8th, 2014 Uncategorized Comments Off on (MNGA) Distributor Signs Development Contract with Italian National Energy Agency

(CYTR) Aldoxorubicin in Advanced Soft Tissue Sarcomas, Global Phase 2b Clinical Results Good

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS).

Additional analysis determined hazard ratios for the primary endpoint of progression-free survival (PFS) by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37 (95% confidence interval, range of 0.212 to 0.643) (p=0.0004), reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59 (95% confidence interval, range of 0.36 to 0.96) (p=0.034), reflecting a 41% reduction in the risk of disease progression. Hazard ratios – the likelihood that the study endpoint (in this case tumor progression) will be reached during a given period – are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups.

CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology (ASCO) Meeting in June, 2014 in Chicago, Illinois.

CytRx President and CEO Steven A. Kriegsman commented, “Because of the tremendous potential for aldoxorubicin to treat soft tissue sarcomas and other common cancers, it is important that we present the initial trial analyses in a timely manner. We are very pleased that additional statistical analyses strongly support the earlier top-line results, which reinforces our confidence in the ability of our linker technology to target the release of doxorubicin directly at the site of cancer.”

As initially reported on December 11, 2013, both the investigator assessment and central lab review showed subjects treated with aldoxorubicin demonstrated highly statistically significant better clinical outcomes than those receiving standard doxorubicin therapy for STS. Specifically, both assessments showed an unambiguous 80% to 100% improvement in PFS among patients treated with aldoxorubicin.

In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).

About the Global Phase 2b Clinical Trial Design

The study examined 123 subjects who received either aldoxorubicin or doxorubicin in a 2:1 randomization, respectively. Aldoxorubicin was administered to 83 subjects at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) as a 30-minute intravenous infusion on Day 1 of each cycle, while doxorubicin (75 mg/m2) was administered to 40 subjects as a 5-30 minute infusion on Day 1 of each cycle. A cycle of therapy was defined as a 3-week (21-day) period. Multiple cycles were administered until the subject was withdrawn from therapy or until a maximum of 6 cycles were administered. CT scans were obtained every 6 weeks to assess tumor response and progression, and adverse events were collected in a case report form.

About Soft Tissue Sarcoma

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of STS; and in 2013 more than 11,400 new cases will be diagnosed in the U.S., and approximately 4,400 Americans will die from STS. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in subjects with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in subjects with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for subjects with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in subjects with late-stage glioblastoma (brain cancer), and plans to initiate a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that the results of any future human testing of aldoxorubicin, including the final data from the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response or safety results similar to the data described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Wednesday, January 8th, 2014 Uncategorized Comments Off on (CYTR) Aldoxorubicin in Advanced Soft Tissue Sarcomas, Global Phase 2b Clinical Results Good

(LEDS) C35 LEDs Create Stunning Accents in Twenty First Light’s Hotel Alpha Project

Dramatic Facade Lighting Delivers 70% Energy Savings

CHUNAN, Taiwan, Jan. 7, 2014  — The tourist hotel complex (THC) Alpha in Moscow recently received a dramatic new façade wall-wash from Twenty First Light ltd, a Russian manufacturer of LED luminaire solutions, using SemiLEDs Corporation (Nasdaq:LEDS), C35 color and warm white LEDs. With substantial product support from SemiLEDs, Twenty First Light developed three types of saturated purple and warm white spotlights for the project to achieve both a powerful visual impact and high reliability for the distinctive lighting scheme.

“THC Alpha is a high profile landmark in Moscow, and as such, this was a high-exposure project for Twenty First Light that demanded a solution which would start out visually appealing, and then stay that way over the life of the installation,” commented Sergey Stakharny, Director of Twenty First Light. “It was very important to us that the LED manufacturer both understood what we were trying to achieve, and would provide flexible support that minimized our engineering challenge while streamlining the project and maximized the reliability of the installed luminaires. SemiLEDs was able to meet those needs, contributing to the success of this program.”

Twenty First Light tackled the project by developing three distinct types of luminaires, including 40W saturated purple spotlights for the individual balconies on the building’s side, as well as narrow-beam 100W purple and 70W warm white spotlights illuminating the building façade for a color-fade effect from bottom to top. In addition, a series of prototype 150W RGB color-changing spotlights, also based on SemiLEDs C35 LEDs, were developed to allow on-site testing of different hue and saturation effects. With the final selection being a saturated purple, Twenty First Light was able to optimize the performance and value by engineering a static combination of blue and red LEDs matching the specified and tested shade. The LEDs were surface mounted on a single aluminum array plate, and supplemented by secondary optics to achieve a 10-degree beam angle. The 100W purple and 70W warm-white spotlights respectively replaced 400W and 250W high pressure sodium lamps netting over 70% energy savings.

“We were very pleased to support Twenty First Light in the development of these customized luminaires constructed around SemiLEDs C35 family of LEDs,” commented Dr. Ilkan Cokgor, Executive VP of Sales and Marketing for SemiLEDs. “One big promise of LEDs is to enable the kind of design flexibility that Twenty First Light devised, allowing the end-specifier to see a dynamic test luminaire for color selection, and then translating that into a cost-optimized, and highly reliable production solution set. That flexibility demands a wide product offering, robust technology, and a manufacturer that has the ability to interact with the luminaire designers with individualized support. It’s what distinguishes SemiLEDs as both a technology and solutions leader.”

Images: http://www.veriphos.com/client/semileds/thc-alpha/

About SemiLEDs Corporation

SemiLEDs develops and manufactures LED chips and LED components primarily for general lighting applications, including street lights and commercial, industrial and residential lighting, along with specialty industrial applications such as ultraviolet (UV) curing, medical/cosmetic, counterfeit detection, and horticulture. SemiLEDs sells blue, green and UV LED chips. For product information, please visit www.semileds.com, email sales@semileds.com, or tel +866 (37) 586-788 (Taiwan)

About “Twenty First Light” ltd

Founded in 2010, “Twenty First Light” ltd. is a Russian manufacturer of LED products for the industrial, administrative, street and architectural lighting. Notable projects include Lighting RZD car repair workshops, Lighting Machinery & Industrial Group N.V. workshops, and “Neoflowers” Shop design lighting in Vremena Goda Galleries. Visit www.21svet.ru or www.21light.ru

Forward Looking Statements

This press release contains statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any projections of future revenues, income, margins or other financial information; any statements about historical results that may suggest trends for SemiLEDs’ business; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief regarding recovery of the LED industry, market opportunities and other future events or technology developments; any statements regarding SemiLEDs’ position to capitalize on any market opportunities; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are based on current expectations, estimates, forecasts and projections of future SemiLEDs’ or industry performance based on management’s judgment, beliefs, current trends and market conditions and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. SemiLEDs’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) and other SemiLEDs filings with the SEC (which you may obtain for free at the SEC’s website at http://www.sec.gov) discuss some of the important risks and other factors that may affect SemiLEDs’ business, results of operations and financial condition. SemiLEDs undertakes no intent or obligation to publicly update or revise any of these forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

CONTACT: Media contact:
         Veriphos Communications
         +1 512-257-9888
         tomg@veriphos.com

         Corporate Communications:
         Connie Chen
         +886 (37) 586-788 ext 8121
         connie.chen@semileds.com
Tuesday, January 7th, 2014 Uncategorized Comments Off on (LEDS) C35 LEDs Create Stunning Accents in Twenty First Light’s Hotel Alpha Project

(PCYC) Independent Data Monitoring Committee recommends Phase III study of IMBRUVICA™

SUNNYVALE, Calif., Jan. 7, 2014  — Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICATM (ibrutinib) versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival (the primary endpoint of the study, which was evaluated by an independent review committee) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Further, IMBRUVICA  showed statistically significant improvement in overall survival (a key secondary endpoint of the trial). The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience.  The IDMC recommended that the sponsor provide access to IMBRUVICA  for subjects on the ofatumumab arm.

“We are very pleased with the vigilance and professional expertise that our IDMC exercised in monitoring this study.  The results seen at the interim analysis of the RESONATE trial are robust and consistent,”  said Fong Clow, Sc. D, Senior Vice President of Biometrics at Pharmacyclics.

Pharmacyclics has informed the U.S. Food and Drug Administration (FDA) of the recommendations of the IDMC. Similarily, Janssen, the co-developer of IMBRUVICA, has informed the European Medicines Agency  (EMA). Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months.

“I am tremendously proud of the accomplishment of the Pharmacyclics team for their effort and execution as well as the collaboration with the clinical sites toward this high quality study. This collaboration resulted in expeditious enrollment, and rapid data collection and analysis.  This global study involving 391 patients was conducted at more than 70 clinical sites in 10 countries,” said Maria Fardis, PhD, Chief of Oncology Operations and Alliances at Pharmacyclics.

“We express our appreciation to the patients, the investigators and the entire Pharmacyclics and Janssen teams for overcoming the barriers and challenges associated with this exciting scientific outcome,” said Robert Duggan, Chief Executive Officer and Chairman of the Board of Pharmacyclics.

The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.

About RESONATE

RESONATE is a randomized, multicenter, open-label Phase III study of single agent  IMBRUVICA (ibrutinib) versus single agent ofatumumab in patients with relapsed or refactory CLL or relapsed or refractory SLL with measurable nodal disease and who were not eligible for treatment with purine analog-based therapy. The study enrolled 391 patients who had received at least one prior therapy. Patients were randomized to receive 420 mg of IMBRUVICA orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity. Patients randomized to the ofatumumab arm who experienced disease progression were evaluable for consideration of subsequent IMBRUVICA therapy.

About CLL/SLL

CLL, a B-cell malignancy, is a slow-growing blood cancer of the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 16,000 patients in the U.S. are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the U.S. CLL is a chronic disease that predominantly occurs in the elderly with a five-year survival of approximately 82 percent. Patients commonly receive multiple lines of treatment over the course of their disease. When cancer cells are located mostly in the lymph nodes, the disease is called SLL. CLL and SLL are considered to be different manifestations of the same underlying disease; they share similarities in signs and symptoms, genetic features, disease progression and treatment.

About IMBRUVICA

IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. For more information about IMBRUVICA, including the full prescribing information, please visit www.IMBRUVICA.com. IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. It is one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway, enabling Pharmacyclics to rapidly bring this medicine to patients in need.

About Pharmacyclics

Pharmacyclics® is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.

To date, 9 Phase III trials have been initiated with IMBRUVICA (ibrutinib) and a total of 38 trials are currently registered on www.clinicaltrials.gov. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize IMBRUVICA.

Pharmacyclics is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at www.pharmacyclics.com.

The following safety information is described in the package insert for the use of IMBRUVICA in patients with mantle cell lymphoma who have received at least one prior therapy:

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hemorrhage – 5% of patients with MCL had ≥ Grade 3 bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). Bleeding events including bruising of any grade occurred in 48% of patients with MCL treated with 560 mg daily. The mechanism for the bleeding events is not well understood. Consider the benefit-risk of IMBRUVICA in patients requiring antiplatelet or anticoagulant therapies and the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and non-fatal infections have occurred. At least 25% of patients with MCL had infections ≥ Grade 3, according to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor patients for fever and infections and evaluate promptly.

MyelosuppressionTreatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients. These included neutropenia (29%), thrombocytopenia (17%) and anemia (9%). Monitor complete blood counts monthly.

Renal Toxicity – Fatal and serious cases of renal failure have occurred. Treatment-emergent increases in creatinine levels up to 1.5 times the upper limit of normal occurred in 67% of patients and from 1.5 to 3 times the upper limit of normal in 9% of patients. Periodically monitor creatinine levels. Maintain hydration.

Second Primary Malignancies – Other malignancies (5%) have occurred in patients with MCL who have been treated with IMBRUVICA, including skin cancers (4%) and other carcinomas (1%).

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most commonly occurring adverse reactions (≥ 20%) in the clinical trial were thrombocytopenia*, diarrhea (51%), neutropenia*, anemia*, fatigue (41%), musculoskeletal pain (37%), peripheral edema (35%), upper respiratory tract infection (34%), nausea (31%), bruising (30%), dyspnea (27%), constipation (25%), rash (25%), abdominal pain (24%), vomiting (23%) and decreased appetite (21%).

*Treatment-emergent decreases (all grades) of platelets (57%), neutrophils (47%) and hemoglobin (41%) were based on laboratory measurements and adverse reactions.

The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) were pneumonia (7%), abdominal pain (5%), atrial fibrillation, diarrhea (5%), fatigue (5%), and skin infections (5%). Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients.  Ten patients (9%) discontinued treatment due to adverse reactions in the trial (N=111).

The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred in 14% of patients.

DRUG INTERACTIONS

CYP3A Inhibitors – Avoid concomitant administration with strong or moderate inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

CYP3A Inducers – Avoid co-administration with strong CYP3A inducers.

SPECIAL POPULATIONS – Hepatic Impairment – Avoid use in patients with baseline hepatic impairment.

Because everyone is different, it is not possible to predict what side effects any one patient will have. Patients with questions or concerns about side effects should talk to their doctor.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.

For more information please read the IMBRUVICA Full Prescribing Information at www.IMBRUVICA.com.

NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements, including our expected liquidity position and timing of the receipt of certain milestone payments, and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words “anticipate”, “believe”, “estimate”, “expect”, “expectation”, “goal”, “should”, “would”, “project”, “plan”, “predict”, “intend”, “target” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, expected liquidity or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our transition report on Form 10-K for the six month period ended December 31, 2012 and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management’s expectations or otherwise, except as may be required by law.

Tuesday, January 7th, 2014 Uncategorized Comments Off on (PCYC) Independent Data Monitoring Committee recommends Phase III study of IMBRUVICA™

(PLUG) to Develop Fuel Cell Range Extenders for FedEx

LATHAM, N.Y., Jan. 7, 2014  — Plug Power Inc. (Nasdaq:PLUG), a leader in providing clean, reliable energy solutions, today announced it will develop hydrogen fuel cell range extenders for 20 FedEx Express electric delivery trucks, allowing FedEx Express to nearly double the amount of territory the vehicles can cover with one charge.

This $3 million project is funded by the US Department of Energy (DOE) and includes project partners FedEx Express, Plug Power and Smith Electric Vehicles. The resulting hybrid vehicles will be powered by lithium-ion batteries and a 10-kilowatt Plug Power hydrogen fuel cell system. The fuel cell solution is based on Plug Power’s GenDrive Series 1000 product architecture.

Currently, electric delivery trucks are limited to traveling about 80 miles per charge. By doubling the vehicle range, Plug Power’s range extender makes battery-based electric vehicles feasible for nearly all delivery routes. It is an enabling technology that makes electric-powered delivery vehicles a viable solution for a wide range of applications, including parcel delivery trucks, taxis, post office trucks and port vehicles.

Customer interest in this technology provides Plug Power with a market expansion opportunity that leverages its existing technology-set and industry-leading hydrogen fuel cell experience with development funds provided by the DOE. Through successful trials and execution with FedEx Express, Plug Power will display how its range extender solution increases delivery fleet efficiency to over 50% coupled with an approximately 35 to 40% decrease in fuel expenses, when compared to diesel trucks.

“Early customer experiences with electric delivery vehicles have been overwhelmingly positive. But only 1% of these vehicles are electric today; we think that this range extender provides the added distance and quick refueling capabilities needed to really grow this market,” said Andy Marsh, Plug Power CEO. “Plug Power’s expertise in the materials handling market – where we have more than 90% market share – is an ideal base on which to build this technology. We thank the DOE for selecting us and look forward to working with our partners to help this market take off.”

About Plug Power Inc.

The architects of modern fuel cell technology, Plug Power is revolutionizing the industry with cost-effective power solutions that increase productivity, lower operating costs and reduce carbon footprints. Long-standing relationships with industry leaders forged the path for Plug Power’s key accounts, including Walmart, Sysco, P&G and Mercedes. With more than 4,000 GenDrive units deployed to material handling customers, accumulating over 16 million hours of runtime, Plug Power manufactures tomorrow’s incumbent power solutions today. Additional information about Plug Power is available at www.plugpower.com.

Plug Power Inc. Safe Harbor Statement

This communication contains statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements contain projections of our future results of operations or of our financial position or state other forward-looking information. These forward-looking statements include, without limitation, statements regarding financial expectations for the fourth quarter of 2013 and the year 2014, growth prospects for future orders, bookings and revenues, EBITDA projections, reductions in material and service costs and alternative supply sources. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Investors are cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability, the risk that we expect we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that we do not have enough cash to fund our operations to profitability and if we are unable to secure additional capital, we may need to reduce and/or cease our operations; the risk that a “going concern” opinion from our auditors, KPMG LLP, could impair our ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives; the recent restructuring plan we adopted may adversely impact management’s ability to meet financial reporting requirements; our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue; the risk that pending orders may not convert to purchase orders; the risk that our continued failure to comply with NASDAQ’s listing standards may result in our common stock being delisted from the NASDAQ stock market, which may severely limit our ability to raise additional capital; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our GenDrive systems; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to improve system reliability for our GenDrive systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; and other risks and uncertainties discussed under “Item IA—Risk Factors” in Plug Power’s annual report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013 and as amended on April 30, 2013 and the reports Plug Power filed from time to time with the SEC. These forward-looking statements speak only as of the date on which the statements were made and are not guarantees of future performance. Except as may be required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this communication.

CONTACT: Press Contact
         Teal Vivacqua
         Plug Power Inc.
         518.738.0269
         media@plugpower.com
Tuesday, January 7th, 2014 Uncategorized Comments Off on (PLUG) to Develop Fuel Cell Range Extenders for FedEx

(LIVE) Capturing Restaurants in Large Numbers Over Groupon and LivingSocial

NEW YORK, NY–(Jan 7, 2014) – When Americans are hungry, they want to eat now, not next week, not next month, but right this minute, and they wouldn’t mind saving some money in the process. LiveDeal, Inc.’s (NASDAQ: LIVE) innovative new platform www.livedeal.com gives consumers that opportunity. With its geo-location, business owners can attract real-time customers who are looking to save money instantly. In the fourth quarter of 2013, the company began building its brand in the $660 billion dining industry and chose San Diego, California, as its launch city. According to the numbers it’s already a huge success.

Jon Isaac, CEO of LiveDeal, announced that he’s already captured about a thousand dining establishments or 20 percent of the restaurants in San Diego. This is mind boggling considering most daily deal companies have little more than two dozen participating restaurants at any given time.

The concept is so simple, it’s genius. Unlike Groupon (GRPN) and LivingSocial, LiveDeal’s platform gives restaurants full control and flexibility to instantly publish customized offers whenever they wish to attract customers. This flexibility and immediacy could explain why restaurants have fallen in love with the concept. Whether it’s a Tuesday from noon to 6 PM, or a Thursday from 3 PM to 7 PM, restaurants have the ability to create any type of promotion, on any day, and at any time. LiveDeal’s platform is a win-win for both the restaurant and hungry diners who can immediately see all “live” deals using any mobile device or by going online and take advantage of those deals as restaurants post them real-time.

When asked what makes LiveDeal work, Isaac said, “LiveDeal works because it was developed with both the business and the user in mind. For Restaurants, they want a cost-effective way to attract traffic on days they need business and ideally the right amount of traffic. For livedeal.com users, especially mobile users, they’re ready to eat, and looking to save money, so that impulse plays a big role in the platform’s success. Livedeal.com is the online marketplace where both businesses and consumers can communicate and interact in real-time.”

After diners identify a deal on the site, they transact directly with the restaurant, eliminating the need for LiveDeal to act as an intermediary in the sale. This is another huge win for LiveDeal and an added advantage over Groupon and others who require signing up to their sites, and entering credit card information in order to complete the deal.

Isaac said, “We feel we have created a model that makes sense in an industry reliant on real-time information. The daily consumer is interested in finding value, and equally important, restaurants are interested in a cost-effective, controlled method of increasing traffic and growing a loyal customer base at their restaurants.”

The idea has worked so well that LiveDeal has already moved into Los Angeles, and has plans to launch its unique platform in cities across the U.S. In December, the company added LA to the livedeal.com family and Isaac says in a few short weeks, LiveDeal has already brought hundreds of L.A.’s more than 22,300 restaurants on board.

The concept makes so much sense that LiveDeal is attracting local restaurants and national chain restaurants as well including; Olive Garden, Outback Steakhouse, Applebees, Hooters and Dave and Busters who are taking advantage of drawing hungry patrons to their business while improving upon their daily profits. Isaac said that he’s seeing “better-than-expected results in return visitors to the site, and larger restaurant chains are now providing LiveDeal with exclusive deals previously unavailable to the public.” This early success for LiveDeal is starting to attract attention, and we at Stock Market Media will be initiating coverage with a report due out this week. With the company’s low float, it likely won’t take long to see the price grow along with the number of cities that LiveDeal adds to its platform.

About Stock Market Media Group

SMMG is a full service IR firm specializing in Research and Content Development. It offers a platform for corporate stories to unfold through the media with Reports, Interviews and Articles. For more information and to read disclaimers and disclosures: www.stockmarketmediagroup.com.

Contact:
Stock Market Media Group
Email Contact

Tuesday, January 7th, 2014 Uncategorized Comments Off on (LIVE) Capturing Restaurants in Large Numbers Over Groupon and LivingSocial

(VNRX) MissionIR Releases Exclusive Audio Interview With CEO Cameron Reynolds

ATLANTA, GA–(Jan 7, 2014) – MissionIR today announces the online availability of its interview with VolitionRx (OTCQB: VNRX) president and Chief Executive Officer Cameron Reynolds. The full audio interview is available at http://vnrx.missionir.com/interview.html.

VolitionRx is a cancer diagnostics company focused on bringing to market its inexpensive, accurate, and minimally invasive cancer detection blood tests. The company’s initial focus is on diagnostic testing for colorectal cancer, the third most common cancer diagnosed in the United States.

The company recently commenced a large clinical trial involving 16,000 patients to assess the accuracy of Volition’s blood-based test. While the current focus is on developing a diagnostic test for colorectal cancer, future plans call for expansion into detection of various other cancers as well. For the time being, however, the company recognizes the great need for developing less expensive, less invasive, but accurate screening tests.

“Being a small company and colorectal being a multi-billion dollar market in itself, we’re focusing on getting product out for that. But it’s certainly something we’d be very keen to expand into other cancers as soon as we’re through the process of developing this diagnostic for colorectal cancer,” Reynolds says.

In addition to detailing the significant accuracy of blood-based tests, Reynolds discusses his own extensive professional background as well as that of the company’s management and scientific teams, which collectively have decades of relative experience.

Reynolds also recaps several of Volition’s recent significant achievements and provides insight into what to expect out of the company in 2014.

“It’s been a very pivotal year for the company and next year we’ll begin to get the results from this large clinical trial coming through, so there are some very large data points coming in the first few quarters of the year, which if they continue to go well will be transformational for the company and really put us on the map as a very stable, technologically superior platform for detecting colorectal cancer,” he says. “… We’re beginning the process next year of beginning legal ability to sell our tests in Europe and start the process of U.S. FDA trials.”

Wrapping up the interview, Reynolds notes that Volition aims to uplist to a major stock exchange in the second half of 2014 to fully access capital markets and continue company growth.

About VolitionRx

VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream — an indication that cancer is present.

VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centered in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the US and ultimately, worldwide.

For additional information, please visit the Company’s corporate Website: www.VolitionRx.com

This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.

VolitionRx Ltd.
www.VolitionRx.com
201-618-1750
info@VolitionRx.com

Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com

Tuesday, January 7th, 2014 Uncategorized Comments Off on (VNRX) MissionIR Releases Exclusive Audio Interview With CEO Cameron Reynolds

(ATNM) to Present at Biotech Showcase™ 2014

Actinium Pharmaceuticals, Inc. (OTCQB: ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that Dr. Kaushik J. Dave, President and CEO, will present at the Biotech Showcase™ 2014 conference from January 13th to 15th, 2014. Dr. Dave will present a corporate update on Monday, January 13, 2014 at 4:30 pm Pacific.

Presentation Information:
Date: Monday, January 13, 2014
Time: 4:30 pm Pacific
Location: Parc 55 Wyndham Hotel: Mission II Room, San Francisco, CA
Webcast: http://www.media-server.com/m/p/qbc4c7nh

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.

For more information:

Visit our web site www.actiniumpharmaceuticals.com

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Tuesday, January 7th, 2014 Uncategorized Comments Off on (ATNM) to Present at Biotech Showcase™ 2014

(EONC) Quadruples Telecommunications Patent Portfolio

CUPERTINO, CA–(Jan 6, 2014) – Inventergy Inc. (NASDAQ: EONC) has announced today that it has acquired approximately 500 patent assets from Panasonic Corporation (a Fortune 100 global electronics company). The portfolio covers key technologies in 3G and 4G communications, a field where Panasonic has been an early technology innovator.

This transaction marks Inventergy’s second significant patent portfolio acquisition in the telecommunications space in approximately six months, and increases the company’s portfolio to more than 660 patents. The portfolio, among other things, applies broadly to radio access network communications technologies and spans a number of key market segments including telecommunications operators, base station equipment vendors, and end-user equipment vendors. Inventergy has currently identified more than 100 companies within these primary licensee market segments that could benefit from a license to these important mobile broadband intellectual property assets.

Joe Beyers, Chairman and CEO of Inventergy, stated, “We are extremely pleased to have secured a second patent portfolio, in such a short time, which significantly increases our overall licensing capabilities. This acquisition validates Inventergy’s strategic model of establishing long-term relationships with industry leading Fortune 500 technology companies, helping to unlock the value of their high quality assets, the fruits of their significant investments in research and development, in an above-board and professional manner. In addition to providing a strong complement to our existing telecommunications patent portfolio, these assets cover key technologies in 3G and 4G communications, an industry in which Panasonic has been an early technology innovator and standards setter.”

These new IP assets provide geographic coverage in 18 countries where there are more than 80 Telecom Operators handling over 2.5 billion mobile broadband connections. This industry continues its rapid growth as users demand more powerful tablets, PCs, notebooks and other mobile devices from equipment manufacturers, and base station equipment vendors respond by building new towers for operators to support the increasing need for 2G/3G and now 4G radio communications.

Mr. Beyers continued, “Inventergy remains committed to establishing itself as a market leader within the rapidly changing intellectual property industry. Moving forward we will remain focused on adding high quality, technologically important patent portfolios spanning across the telecommunications and other industries, delivering value to both technology leaders and industry licensees.”

On December 18, 2013, Inventergy Inc. and eOn Communications Corporation (NASDAQ: EONC) announced entering into a merger agreement whereby Inventergy will merge into a wholly owned subsidiary of eOn. Upon completing the merger, eOn Communications will be renamed Inventergy Global, Inc. and Inventergy stockholders in the aggregate will control eOn.

About Inventergy Inc.
Inventergy Inc. is an intellectual property acquisition and licensing company dedicated to identifying, acquiring and licensing the patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, former head of IP and global strategy at Hewlett-Packard, the company leverages decades of experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns. Inventergy aspires to enable a new world of IP value creation built upon a more transparent, above-board and ethical business platform. Inventergy’s current portfolio now contains over 660 patent assets (including patents related to industry standards), from two Fortune Global 500 and Gartner-recognized technology leaders in the telecommunications industry. For more information about Inventergy, visit the website at www.inventergy.com.

Forward-Looking Statements
This press release contains statements, estimates, forecasts and projections with respect to future performance and events, which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent and belief or current expectations of the Company and its affiliates and subsidiaries and their respective management teams. These statements may be identified by the use of words like “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “seek” and similar expressions and include any projections or estimates set forth herein. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, that actual results may differ materially from those projected in the forward-looking statements.

Investors:
Chris Camarra
Director, Investor Relations
Email Contact

Monday, January 6th, 2014 Uncategorized Comments Off on (EONC) Quadruples Telecommunications Patent Portfolio

(ETAK) to Present at the Sidoti & Company Semi-Annual Microcap Conference in NY

OKLAHOMA CITY, Jan. 6, 2014  — Elephant Talk Communications Corp. (NYSE MKT: ETAK), a leading international provider of Software Defined Network Architecture (Software DNA™) platforms and cyber security solutions, today announced that Steven van der Velden, Chairman and CEO, will present at the Sidoti & Company Semi-Annual Microcap Conference in New York City on January 13, 2014.

Conference Presentation Details:
Where: Grand Hyatt New York, 109 East 42nd Street
When: Monday, January 13, 2014
Presentation Time: 2:10 p.m. Eastern
Room: Estate 1
Conference Website: http://microcap.sidoti.com/index.asp

 

About Elephant Talk:
Elephant Talk Communications Corp. (NYSE MKT: ETAK), is a leading international provider of mobile proprietary Software Defined Network Architecture (Software DNA™) platforms for the telecommunications industry.  The company empowers Mobile Network Operators (MNOs),  Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, superior Industry Expertise and high quality Customer Service without substantial upfront investment. Elephant Talk counts several of the world’s leading Mobile Operators amongst its customers, including Vodafone, T-Mobile, Zain and Iusacell. Visit: www.elephanttalk.com.

About ValidSoft:
ValidSoft provides advanced mobile- and cloud-security solutions. The company’s custom-built sophisticated multi-factor authentication platform (SMART™) takes full advantage of telecommunications and includes a leading proprietary voice biometric engine. The platform combats electronic fraud and safeguards consumer privacy across internet, mobile banking, card, mobile and fixed line telecommunication channels. The company counts some of the largest financial institutions among its customers. ValidSoft is the only security software company in the world that has been granted three European Privacy Seals. Visit: www.validsoft.com.

Media Contacts:

Investor Relations:
Steve Gersten
Elephant Talk Communications Corp.
+ 1 813 926 8920
Steve.Gersten@elephanttalk.com

Thomas Walsh
Alliance Advisors
+ 1 212 398 3486
twalsh@allianceadvisors.net

US – Public Relations: Michael Glickman
MWG CO
(917) 596.1883
mike@mwco.net

Monday, January 6th, 2014 Uncategorized Comments Off on (ETAK) to Present at the Sidoti & Company Semi-Annual Microcap Conference in NY

(CTIC) PIXUVRI® Receives Positive Final Appraisal Determination from NICE

– PIXUVRI Deemed Cost Effective for Patients with Multiply Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL) –

SEATTLE, Jan. 6, 2014  — Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported that the National Institute for Health and Care Excellence (NICE), the independent body responsible for driving improvement and excellence in the health and social care system in the United Kingdom (UK), has issued its Final Appraisal Determination (FAD) for PIXUVRI® (pixantrone). The positive final draft guidance determines PIXUVRI cost effective and recommends funding the treatment as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), which includes diffuse large B-cell lymphoma (DLBCL). CTI estimates that there are approximately 1,600 to 1,800 people in the UK diagnosed with multiply relapsed aggressive B-cell NHL per year.

James A. Bianco, M.D., President and Chief Executive Officer of CTI stated, “The positive recommendation by NICE for the funding of PIXUVRI means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting.”

The NICE Appraisal Committee reviewed CTI’s updated data analysis showing PIXUVRI’s cost effectiveness and recommended the treatment as an option for certain people with histologically confirmed aggressive B-cell NHL who have previously received rituximab and are receiving PIXUVRI as a third- or fourth-line treatment.

The FAD further recommends the prescription of PIXUVRI for as long as CTI makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the UK’s Department of Health.

The FAD forms the basis of the final guidance to the NHS in England and Wales and is expected to be published in February 2014. Once the final guidance is published, the NHS must fully implement it within 90 days. CTI expects to officially launch PIXUVRI in England and Wales in early spring, when the FAD has been largely implemented.

Professor John Radford, a lymphoma expert at The University of Manchester and The Christie NHS Foundation Trust in Manchester – both part of the Manchester Cancer Research Centre said, “DLBCL is the most common type of aggressive NHL and despite undoubted progress over the last 10 years resulting from the introduction of better first-line therapy, the disease still recurs in some patients. The recent recommendation by NICE for the funding of PIXUVRI provides an additional treatment option for these patients and is a welcome development.”

Professor Finbarr E. Cotter, Professor of Haematology and Chair of Experimental Haematology, Centre for Haemato-Oncology, Barts Cancer Institute, and representative for the British Society for Haematology (BSH) commented, “The availability of PIXUVRI means physicians will be able to extend an approved salvage regimen to those patients that fail second- or third-line therapy. The data from the pivotal EXTEND Phase 3 trial of PIXUVRI clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL.”

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite — both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.

About NHL

NHL is the sixth most common cancer in the UK; in 2010, 12,180 people were diagnosed with the disease.1 NHL is caused by the abnormal proliferation of lymphocytes, cells that are key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common and accounts for about 55 percent of NHL cases.2 After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease.3 Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50 percent are expected not to respond.3 For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only.3

About Conditional Marketing Authorization

Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for PIXUVRI, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has accepted PIX306, CTI’s ongoing randomized controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding the expected number of people in the UK with multiply relapsed aggressive B-cell NHL per year, expectations with respect to the development of CTI and its product and product candidate portfolio, the expected benefits and effectiveness of PIXUVRI, NICE’s processes, pricing arrangements and the cost-effectiveness and availability of PIXUVRI to patients in the UK. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that CTI may not obtain reimbursement for PIXUVRI in certain markets in the European Union as planned, that the conditional marketing authorization for PIXUVRI may not be renewed, that the second Phase 3 clinical trial of pacritinib will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

References:
1. Cancer Research UK http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/commoncancers/ Accessed April 2013.
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg ASH Education Book 2011;1:498-505

Contacts:

Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
ebell@ctiseattle.com

In Europe
CTI Life Sciences Limited, Milan Branch
Laura Villa
E: lvilla@cti-lifesciences.com
T: +39 02 89659706
http://www.celltherapeutics.com/italiano

Monday, January 6th, 2014 Uncategorized Comments Off on (CTIC) PIXUVRI® Receives Positive Final Appraisal Determination from NICE