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(SMT) and HMHC Leverage Content/Software to Advance Education
SMART Technologies Inc. (NASDAQ: SMT) (TSX: SMA) and Houghton Mifflin Harcourt (HMH) (NASDAQ:HMHC) have entered into a comprehensive working relationship to advance education through software, content and professional development offerings. The partnership will bring together HMH’s research-based, globally recognized digital curriculum and SMART software through a standards-based approach, to provide teachers and students with the ability to seamlessly collaborate and learn in new and innovative ways. Today’s joint announcement is a lead up to the British Education Training and Technology (BETT) show, the world’s largest gathering of education suppliers and decision makers, to be held in London from January 22 to 26, 2014.
The initial phase of integration will combine HMH’s trusted digital content with SMART amp™ collaborative learning software – the revolutionary, cloud-based solution that offers a single, device-agnostic learning platform on any device that has a browser. It is the ‘glue’ that connects interactive displays, PCs, laptops, tablets and smartphones while enabling teachers and students to collaborate in real time, perform in-class assessment, connect to shared digital workspaces and interact with Web-based learning materials regardless of location or device.
HMH’s market-leading ScienceFusion will become one of the first products to be integrated with SMART amp software. ScienceFusion is a state-of-the-art science program designed to develop important critical thinking and inquiry skills through real world challenges and hands-on activities. The integration with SMART amp software enables students and teachers to access and collaborate with ScienceFusion content anytime, anywhere, using any device. Additional curriculum offerings from HMH will continue to become available through SMART amp software in the coming months.
The collaboration between HMH and SMART will also allow for digital content integration into the award-winning SMART Notebook™ collaborative learning software and professional development offerings to help educators optimize their use of the integrated solutions for improved learning outcomes. SMART has over 25 years of history in creating solutions that support collaborative teaching and learning. Today more than 2.6 million SMART Board® interactive displays are used by over 50 million students and their teachers, and SMART software is used in more than 175 countries around the world.
“SMART amp software will simplify the way teachers and students experience digital content — beyond one single classroom display to multiple devices and mediums,” says Mary Cullinane, Chief Content Officer for Houghton Mifflin Harcourt. “The integration of our trusted, pedagogically-sound curriculum content with SMART’s software will give students and teachers greater flexibility to access and collaborate with world-class learning resources anytime, anywhere, to ensure a better learning experience and long-term success.”
“Houghton Mifflin Harcourt’s world-class learning resources will enrich SMART software by offering premium content across all core subject areas that is optimized for interactive, collaborative learning,” says Greg Estell, President, Education for SMART Technologies. “The integration of HMH’s cutting-edge content with SMART software enables educators to effortlessly transform teaching and learning with visual, interactive and engaging lessons that inspire collaboration and enhance student understanding.”
SMART amp collaborative learning software will be available for commercial release in April 2014 and is now in early stage trials in a number of schools. For more information, visit smarttech.com/cloud.
About Houghton Mifflin Harcourt
Houghton Mifflin Harcourt (NASDAQ:HMHC) is a global learning company with the mission of changing people’s lives by fostering passionate, curious learners. Among the world’s largest providers of pre-K–12 education solutions and one of its longest-established publishing houses, HMH combines cutting-edge research, editorial excellence and technological innovation to improve teaching and learning environments and solve complex literacy and education challenges. HMH’s interactive, results-driven education solutions are utilized by 50 million students in over 150 countries, and its renowned and awarded novels, non-fiction, children’s books and reference works are enjoyed by readers throughout the world. For more information, visit www.hmhco.com.
About SMART
SMART Technologies Inc. is a leading provider of technology solutions that are redefining the way the world works and learns. SMART products enable inspired collaboration in schools and workplaces by turning group work into highly interactive, engaging and productive experiences. SMART delivers integrated solutions of hardware, software and services designed for superior performance and ease of use.
Reader’s advisory
Certain information contained in this press release may constitute forward-looking information or statements. By their very nature, forward-looking information and statements involve inherent risks and uncertainties, both general and specific, and risks that predictions, forecasts, projections and other forward-looking information and statements will not be achieved. We caution readers not to place undue reliance on these statements as a number of important factors could cause the actual results to vary materially from the forward-looking information or statements. We do not assume responsibility for the accuracy and completeness of the forward-looking information or statements. Any forward-looking information and statements contained in this press release are expressly qualified by this cautionary statement.
©2014 SMART Technologies. All third-party product and company names are for identification purposes only and may be trademarks of their respective owners. To view a list of SMART trademarks please visit our Trademarks and Guidelines page.
(GALT) Galectin Inhibitor Demonstrates Efficacy in Preclinical Study
NORCROSS, Ga., Jan. 21, 2014 — Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that data from a preclinical study show its leading galectin-inhibiting drug GR-MD-02 demonstrates an effect on a blood biomarker in an animal model of nonalcoholic steatohepatitis (NASH, or fatty liver disease) with fibrosis. Hyaluronic acid, a well investigated marker of liver fibrosis, was significantly reduced by approximately 33 percent when untreated animals were compared with those treated with GR-MD-02.
In the study, NASH-induced mice were treated with once weekly doses of GR-MD-02 at four different doses for a total of six weeks of treatment. Results revealed that treatment with GR-MD-02 at doses of 10, 30, and 60 mg/kg body weight significantly reduced the plasma levels of hyaluronic acid in the NASH mice. Other biomarkers examined did not change (MIG (monokine induced by interferon gamma) and TIMP-1 (tissue inhibitor of metalloproteinase)) or were not detectable (IP-10 (interferon inducible protein), KC (keratinocyte-derived chemokine), MIP-1α (macrophage inflammatory protein), and MCP-1 (monocyte chemo-attractant protein). Importantly, plasma levels of galectin-3 were measurable and did not change with therapy, indicating that changes in tissue galectin-3 and improvement in NASH histology do not correlate with blood levels of galectin-3 in this model.
“These results in this preclinical model of NASH show that improvement in NASH and fibrosis with GR-MD-02 treatment appear to correlate with plasma levels of hyaluronic acid, a biomarker that has been shown in multiple human studies to correlate with liver fibrosis,” said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. “We are examining the levels of hyaluronic acid as well as multiple other markers of inflammation, cell death and fibrosis in our current Phase 1 clinical trial of GR-MD-02 in NASH patients with advanced fibrosis.”
As previously reported and published in PLOS ONE, the same study showed that GR-MD-02 improved all components of NASH in mice, including fibrosis [http://dx.plos.org/10.1371/journal.pone.0083481].
GR-MD-02 is a proprietary molecule that binds to and inhibits galectin proteins, predominantly galectin-3. Patient enrollment is complete in cohort 1 of a blinded Phase 1 clinical trial of GR-MD-02 for patients with NASH with advanced fibrosis. No serious adverse events have been reported. The Phase 1 first-in-man study is evaluating the safety, tolerability, pharmacokinetics and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis. Following the 70 day study period and analysis of the data, the Company anticipates that initial safety and tolerability results, as well as biomarkers to evaluate for potential disease effect, from the first cohort will be available around the end of the first quarter of this year.
About Fatty Liver Disease with Advanced Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.
About Galectin Therapeutics
Galectin Therapeutics (Nasdaq:GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. These statements include those regarding preclinical data and the potential role for GR-MD-02 and GM-CT-01 in the treatment of liver fibrosis and cirrhosis in humans. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding any preclinical data and potential therapeutic uses and benefits of our drugs and any future pre-clinical or clinical studies are subject to factors beyond our control. Future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of current or future studies, we may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
CONTACT: Galectin Therapeutics Inc. Peter G. Traber, MD, 678-620-3186 President, CEO, & CMO ir@galectintherapeutics.com
(KOOL) & TotipotentRX Statistically Significant Phase Ib Clinical Results in Critical Limb Ischemia
New 60 Minute Rapid Bedside Treatment Substantially Reduces Amputations in No-Option Patients
RANCHO CORDOVA, Calif. and LOS ANGELES, Jan. 21, 2014 — ThermoGenesis Corp. (Nasdaq:KOOL) a cellular therapy medical device company and TotipotentRX Corporation, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular and orthopedic disease announce their co-sponsored Phase Ib clinical trial safety and efficacy results treating no-option patients suffering from critical limb ischemia with Totipotent’s CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment. The companies will host a joint conference call to review the study results in detail on Monday, January 27, 2014 at 2:00pm Pacific (5:00pm Eastern).
The trial achieved both its primary safety and secondary efficacy endpoints at 12 months, achieving statistical significance in five key areas including, major amputation free survival rates (82.4%), both resting and walking pain reduction, improved walking distance, open wound healing and vasculogenesis (generation of new blood vessels) in the treated leg. Furthermore, there were no serious adverse events determined to be related to the therapy. The open label single center study enrolled 17 patients and was completed at Fortis Escorts Heart Institute in New Delhi with Dr. Suhail Bukari, Senior Consultant and Vascular Surgeon serving as the primary investigator. Fortis Escorts Heart Institute and Dr. Bukari previously served as clinical investigator for the Juventas Therapeutics critical limb ischemia trial.
Dr. Bukari noted, “This is a significant breakthrough for medicine as all the patients enrolled were scheduled for amputation of their afflicted limb prior to consenting to the stem cell intervention.” He further noted, “The simple kit process will enable any surgeon treating peripheral vascular disease to have a readily available safe and autologous therapeutic to reverse this debilitating disease.”
CLIRST is a proprietary bedside technology platform and method which uses the patients own bone marrow stem cells to promote tissue repair through activation of natural stem-cell repair pathways, promotion of new blood vessel formation and prevention of on-going cell death. The integrated combination device-biological product called SURGWERKS™ – CLI, contains optimized stem cell harvesting, selection, and delivery disposables in a single kit, and the procedure can be completed on a patient in less than 60 minutes in the operating room with mild sedation as an alternative to major limb amputation. The SURGWERKS-CLI product delivered a mean cell dose of BMCePC (bone marrow concentrate enriched progenitor cells) of 8.04 x 108 ± 3.65 cells in a 20ml final product which was injected intramuscularly in the lower afflicted leg.
“We are extremely excited to demonstrate that our integrated cell therapy SURGWERKS kit has removed the variability that has plagued most stem cell treatments developed to date, especially in treating CLI. This study demonstrated that our SURGWERKS’ amputation free survival rate of 82% is almost 25% higher than alternative therapeutic approaches to date, which we believe is a testament to the quality of our autologous cell formulation and the repeatability of our proprietary process,” said Ken Harris, Chief Executive Officer of TotipotentRX. “The goal of the stem cell therapy is to prevent major limb amputation, and improve quality of life, decrease morbidity and mortality rates, and ultimately reduce total healthcare spend on these patients. We anticipate offering this treatment at a significantly lower cost than non-bedside treatments, and will stay focused on the large U.S., European and Indian markets,” he continued.
“One of the benefits of our long-standing partnership with TotipotentRX, is the successful integration of our cell processing systems into the SURGWERKS-CLI therapy kit,” said Matthew Plavan, Chief Executive Officer of ThermoGenesis, Corp. “Based upon the statistical significance of these Phase Ib trial results, we are highly encouraged with the potential for this therapy to perform well in the next phase of the clinical trial process and to ultimately lead to a curative treatment for CLI and a very large market opportunity for our two companies,” he continued.
Dr. Venkatesh Ponemone, PhD, Executive Director of Clinical Affairs for TotipotentRX and scientific investigator for the study commented that this is the first known study to provide statistically significant angiographic quantitative and qualitative evidence of limb revascularization as independently verified by a core radiology lab.
The statistical significance reached in the phase Ib trial includes:
- Major limb Amputation free survival rates – 82.4%
- Pain reduction – mean VAS score pre-therapy 7.8 ± 0.97 and 12 month follow-up 0.2 ± 0.58 on a scale of 0-10, p=0.0005
- 6-minute walking distance – mean distance pre-therapy of 14.5 meters ± 37.57 and 12 month follow-up of 157 meters ± 100.92, p=0.0039
- Open wound healing – 11 patients had gangrene with or without ulceration pre-treatment and all patients had neither gangrene nor ulceration at 12 month follow-up
- Vasculogenesis in the treated leg – both collateral vessel numbers improved, p=0.0156 in distal thigh, p=0.0313 in proximal leg, and vessel size improvements in the distal thigh, p=0.0156 and proximal leg, p=0.0625, and TcPO2 levels (mean pre-therapy of 14.66 ± 6.93 improved to 35.75 ± 17.04, p=0.0032)
Critical limb ischemia afflicts an estimated 2 million people combined in the United States, European Union and Indian sub-continent, and results in approximately 500,000 amputations each year. The overall prevalence (0.23%) and incidence (0.20%) in the United States increases with age and diabetes status, and 5 year mortality rate post limb amputation reaches nearly 50%.
The companies will host a joint conference call to review the study results in detail on Monday, January 27, 2014 at 2:00pm Pacific (5:00pm Eastern).
Conference call details:
Dial-in (U.S.): | 1-800-860-2442 |
Dial-in (Internationally): | 1-412-858-4600 |
Conference Name: | “ThermoGenesis” |
To listen to the audio webcast of the call during or after the event, please visit http://www.thermogenesis.com/company/investor-relations/webcasts-calls/
An audio replay of the conference call will be available beginning approximately two hours after completion of the call for the following five business days.
To access the replay:
Access number (U.S.): | 1-877-344-7529 |
Access number (Internationally) | 1-412-317-0088 |
Conference ID#: | 385107 |
TotipotentRX Corporation, a U.S. private based cellular therapy research and therapeutics organization (www.totipotentrx.com) develops rapid bedside autologous cellular therapies for cardiovascular and orthopedic indications. They operate world-class clinical research and cellular therapy GMP infrastructure with their clinical partner Fortis Healthcare.
ThermoGenesis Corp., (Nasdaq:KOOL) (www.thermogenesis.com) is a U.S. based leader in developing and manufacturing automated blood processing systems and disposable products that enable the separation, preservation and delivery of cell and tissue therapy products.
In July 2013, TotipotentRX and ThermoGenesis Corp. announced their entry into a merger agreement which will operate under the name Cesca Therapeutics. The merger is subject to TotipotentRX and ThermoGenesis stockholder approval, among other conditions.
Forward-Looking Statement
This press release contains forward-looking statements. Such forward-looking statements include but are not limited to that the proposed merger will be consummated and that the resulting company will be able to become a fully integrated regenerate medicine company, to provide practical, commercializable cell therapies, to rapidly and cost-efficiently develop new clinical trial, to be positioned to commercialize in both developed and emerging markets and to create higher shareholder value. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including the timing of proposed merger, the efficiency of integrating two companies, timing of FDA and foreign regulatory approvals as to products, changes in customer forecasts, our ability to meet customers’ purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers’ products, introduction timing and acceptance of our new products scheduled for fiscal year 2014, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2014. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption “Risk Factors” in our proxy statement/prospectus/consent solicitation and other reports we file with the SEC from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
Non-Solicitation
This press release and the information contained herein shall not constitute an offer to sell, buy or exchange or the solicitation of an offer to sell, buy or exchange any securities, nor shall there be any sale, purchase or exchange of securities in any jurisdiction in which such offer, solicitation, sale, purchase or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information
In connection with the merger, ThermoGenesis has filed a registration statement (including a prospectus) on Form S-4 (File No. 333-19210) with the Securities and Exchange Commission. Holders of ThermoGenesis Common Stock and TotipotentRX Corporation common stock are urged to read the proxy statement/prospectus/consent solicitation and any other relevant documents because it contains important information about ThermoGenesis, TotipotentRX and the merger. A proxy statement will be sent to holders of our Common Stock and a proxy statement/prospectus/consent solicitation will be sent to holders of TotipotentRX Corporation common stock. The proxy statement/prospectus/ consent solicitation and other documents relating to the proposed merger can be obtained free of charge from the SEC’s website at www.sec.gov. These documents can also be obtained free of charge from ThermoGenesis upon written request to ThermoGenesis, Investor Relations, 2711 Citrus Road Rancho Cordova, CA 95742. ThermoGenesis and its directors and executive officers may be deemed to be participants in ThermoGenesis’ solicitation of proxies from its shareholders in connection with the proposed merger. Information regarding the participants and their security holdings can be found in ThermoGenesis’ proxy statement/prospectus/consent solicitation and Form 10-K for the year ended June 30, 2013, as amended, which are available from the SEC.
CONTACT: ThermoGenesis Corp. Web site: http://www.thermogenesis.com Investor Relations +1-916-858-5107, or ir@thermogenesis.com
(CYTR) FDA Approval to Extend Aldoxorubicin Dosing Cycles in Global Phase 3 Trial
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas. The clinical trial is scheduled to begin this quarter. For purposes of the clinical trial, disease progression is defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion. The following table sets forth the cumulative dose of doxorubicin in prior and planned CytRx clinical trials:
Cumulative Doxorubicin Dose | ||||
Recognized maximum dose associated with cardiac toxicity – Doxorubicin | 450 mg/m2 | |||
CytRx Phase 2b Clinical Trial – Aldoxorubicin | 1,560 mg/m2 | |||
CytRx Phase 1b/2 Clinical Trial– Aldoxorubicin | 2,080 mg/m2 | |||
CytRx Pharmacokinetics Clinical Trial – Aldoxorubicin | 1600-3200 mg/m2 | |||
CytRx Pivotal Phase 3 Clinical Trial– Aldoxorubicin | Up to Disease Progression | |||
The study design under the trial’s Special Protocol Assessment (SPA) originally called for dosing to be stopped after six treatment cycles. FDA acceptance of a protocol amendment to include a dose-to-progression regimen demonstrates the superior cardiac safety thus far of administrating a cumulative 2,080 mg/m2 dose of aldoxorubicin as seen in the Company’s recently announced global, Phase 2b clinical trial results (which is equivalent to 1,560 mg/m2 of doxorubicin), which is 3.5 times the recognized maximum cumulative dose of doxorubicin (450 mg/m2) associated with cardiac toxicity (heart damage).
Sant Chawla, M.D., of the Sarcoma Oncology Center in Santa Monica, Calif., and principal investigator of the Phase 3 pivotal trial, commented, “In addition to observing no significant cardiotoxicity of aldoxorubicin to this point, the FDA’s agreement to extend dosing beyond six cycles offers the potential to achieve even greater progression-free survival efficacy results than were demonstrated in CytRx’s recent highly successful global Phase 2b trial for advanced soft tissue sarcomas. As the principal investigator for this trial, I can say that we are very pleased to have the opportunity to provide the maximum benefits of aldoxorubicin to the patients around the world.”
“Current chemotherapy treatments for soft tissue sarcomas have demonstrated limited impact, and other potential treatments have provided no improved benefits in Phase 3 trials,” said CytRx President and CEO Steven A. Kriegsman. “As such there is a significant need for a second-line treatment with greater efficacy and reduced or no measurable cardiac toxicity. This FDA acceptance of extended dosing represents a potential major breakthrough for CytRx and STS patients throughout the world.”
The international, open-label pivotal Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to or have progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapies. Trial patients will be randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen to include dacarbazine, pazopanib (Votrient®), gemcitabine plus docetaxel, doxorubicin or ifosfamide, with up to three comparator regimens to be selected by the investigator at each clinical site. The clinical trial will be conducted at approximately 100 clinical sites in the U.S., Europe, Canada, Latin America and Australia. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival and safety.
Review of Results for Phase 2b Trial with Aldoxorubicin as a First-line Treatment in Advanced Soft Tissue Sarcomas
As initially reported on December 11, 2013, patients treated with aldoxorubicin demonstrated highly statistically significant clinical outcomes compared to those receiving standard doxorubicin therapy for soft tissue sarcomas in both an investigator assessment and a central lab review. 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).
On January 8, 2014, CytRx reported results of additional analyses that determined hazard ratios for the primary endpoint of 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 was 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 was 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 above. 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 patients treated with aldoxorubicin versus patients treated with doxorubicin.
About Soft Tissue Sarcoma
Soft tissue sarcoma 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 soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. 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 450 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 (3½ 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 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, or the Phase 3 clinical trial with aldoxorubicin as a second-line treatment for advanced soft tissue sarcomas, 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.
(CPST) Receives Multiple Orders for Customers in the Permian Basin Shale Play
CHATSWORTH, Calif., Jan. 17, 2014 — Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST), the world’s leading clean technology manufacturer of microturbine energy systems, announced today that it has received orders for two Capstone C1000s and an order for 25 Capstone C65 microturbines to be used for oil and gas production in the Permian Basin located beneath west Texas and southeastern New Mexico.
According to an October 2013 article in Investors Daily, the Permian Basin receives a fraction of the press coverage accorded the Bakken and Eagle Ford, but it has more production potential than these two shale formations combined. The Permian is not just a shale oil play, nor is it a recently developed basin. The Permian currently produces some 900,000 barrels per day of crude, about 12 percent of US oil production. Some analysts expect Permian production to more than double by 2018 to 2 million barrels per day — a level last reached during the 1970s. The Permian Basin is projected to still contain recoverable oil and natural gas resources exceeding what has already been produced. Industry experts estimate that, at current prices, more than $3 trillion worth of oil and more than $300 billion of natural gas are yet to be extracted. These projections dwarf the combined estimated reserves for the Bakken and Eagle Ford.
Horizon Power Systems secured the order for the two Capstone C1000 microturbines to be used by an independent oil and gas producer in the area. This marks Capstone’s first multiple megawatt project in the Permian Basin after previously installing multiple C30s and C65s at project sites in the region. The C1000s will replace unreliable grid service from the local utility and be used to power the client-owned electric grid. This small local grid will supply power to various well locations in addition to the field operations office. The site is expected to be commissioned in March.
Horizon Power Systems also ordered 25 Capstone C65 microturbines to expand operations for multiple existing clients in the Permian Basin. This repeat business demonstrates a high level of customer satisfaction with Capstone microturbines, helping to cement microturbine technology as a preferred option in the U.S. oil and gas industry.
Capstone microturbines were chosen due to their reduced maintenance costs, low exhaust emissions, and higher reliability than traditional engine based generation. The microturbines easily meet Tier 4 emission standards without requiring aftertreatment.
“The Permian Basin currently contributes about 14 percent of the nation’s overall oil and gas production,” said Sam Henry, Horizon Power Systems President. “Horizon is pleased to continue to expand our presence in this dynamic area. This sale – the first multiple megawatt Capstone microturbine installation in the Permian Basin – follows several other C65s and C30s already in place there. Low-emission, low-noise, and low-maintenance Capstone microturbines are the go-to solution for running onsite equipment and meeting customers’ power requirements in the Permian Basin.”
About Capstone Turbine Corporation
Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq: CPST) is the world’s leading producer of low-emission microturbine systems and was the first to market commercially viable microturbine energy products. Capstone Turbine has shipped approximately 7,000 Capstone Microturbine systems to customers worldwide. These award-winning systems have logged millions of documented runtime operating hours. Capstone Turbine is a member of the U.S. Environmental Protection Agency’s Combined Heat and Power Partnership, which is committed to improving the efficiency of the nation’s energy infrastructure and reducing emissions of pollutants and greenhouse gases. A UL-Certified ISO 9001:2008 and ISO 14001:2004 certified company, Capstone is headquartered in the Los Angeles area with sales and/or service centers in the New York Metro Area, Mexico City, Nottingham, Shanghai and Singapore.
The Capstone Turbine Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6212
This press release contains “forward-looking statements,” as that term is used in the federal securities laws, about the use of our products in the oil and gas market and opportunities in the Permian Basin Shale Play. Forward-looking statements may be identified by words such as “expects,” “objective,” “intend,” “targeted,” “plan” and similar phrases. These forward-looking statements are subject to numerous assumptions, risks and uncertainties described in Capstone’s filings with the Securities and Exchange Commission that may cause Capstone’s actual results to be materially different from any future results expressed or implied in such statements. Capstone cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Capstone undertakes no obligation, and specifically disclaims any obligation, to release any revisions to any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
“Capstone” and “Capstone MicroTurbine” are registered trademarks of Capstone Turbine Corporation. All other trademarks mentioned are the property of their respective owners.
CONTACT: Capstone Turbine Corporation Investor and investment media inquiries: 818-407-3628 ir@capstoneturbine.com
(PBMD) CAN-004 Clinical Trial Amendment Approved in Belgium
SYDNEY, AUSTRALIA–(Jan 17, 2014) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima,” the “Company”) today announced that the amended CAN-004 protocol was approved by the Belgian Federal Agency for Medicines and Health Products. This is the first regulatory agency to approve the amended CVac™ clinical trial design. CAN-004 is a multicentre, randomized, phase 2 trial of CVac for the maintenance treatment of epithelial ovarian cancer in remission.
In November 2013, Prima announced significant updates to its CVacTM clinical development program based on progression-free survival results from its randomized CAN-003 trial. In the CAN-003 trial, CVac demonstrated a strong trend of increased progression-free survival in ovarian cancer patients in remission after second line treatment, as compared to those patients who did not receive CVac.
The CAN-004 trial will enroll a new cohort of 210 epithelial ovarian cancer patients in remission after second-line platinum-based chemotherapy. 76 patients in remission after first-line surgery and chemotherapy have previously been randomized onto the CAN-004 trial. Overall survival (OS) will be the primary endpoint with secondary endpoints including progression-free survival (PFS), adverse events, and immune monitoring.
Matthew Lehman, Prima’s CEO: “We are very pleased to have received approval for the CAN-004 protocol amendment in Belgium, and we anticipate other regulators will soon follow. It is exciting that we will soon be able to re-start recruitment of the CVac clinical trial for ovarian cancer.”
Prima maintains updated information about the CAN-004 trial on the U.S. National Institutes of Health clinical trial registry at www.clinicaltrials.gov and will provide regular updates in the Company’s quarterly conference calls.
About Prima BioMed
Prima BioMed is a globally active leader in the development of personalized immunocellular therapeutic products for the treatment of cancer. Prima is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Prima’s lead product is CVac™, an autologous dendritic cell-based product currently in clinical trials. www.primabiomed.com.au.
For further information please contact:
USA Investor/Media:
Ms. Jessica Brown
Prima BioMed Ltd.
+1 (919) 710-9061
Email Contact
Australia Investor/Media:
Mr. James Moses
Mandate Corporate
+61 (0) 420 991 574
Email Contact
Europe Investor/Media:
Mr. Axel Muhlhaus
edicto GmbH
+49 (0) 69 905505-52
Email Contact
(YRCW) and IBT Reach Tentative Agreement on Revised Proposal
OVERLAND PARK, Kan., Jan. 17, 2014 — YRC Worldwide Inc. (Nasdaq:YRCW) announced today that it has reached a tentative agreement with officials of the International Brotherhood of Teamsters on an extension of its collective bargaining agreement to March 2019.
The tentative agreement contains a number of revisions to the company’s previous proposal which address concerns raised by the Teamsters leadership and its members. The previous proposal, which was voted without reaching an agreement with the union was not ratified by the company’s employees. In contrast, this MOU extension was negotiated with the union.
“The outcome of this week’s discussions is critical to the future of the company. The MOU extension is something our employees can have confidence is the best – and only remaining – path forward,” said James Welch, chief executive officer of YRC Worldwide.
Details of the revised proposal will be reviewed by local union officials at a “two-person” meeting of local union officials to be held on Tuesday, January 21, 2014.
Forward-Looking Statements
This news release contains 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. The words “will,” “would,” “anticipate,” “expect,” “believe,” “intend” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are inherently uncertain and are subject to significant business, economic, competitive, regulatory and other risks, uncertainties and contingencies, known and unknown, many of which are beyond the company’s control. It is important to note that the results of future discussions with the Teamsters and any intention to conduct or outcome of any re-vote on the above-mentioned proposal will be determined by a number of factors, including (among others) those risk factors that are from time to time included in the company’s reports filed with the SEC, including the company’s reports on Forms 10-K and 10-Q and the company’s Current Report on Form 8-K filed on December 9, 2013.
About YRC Worldwide
YRC Worldwide Inc., a Fortune 500 company headquartered in Overland Park, Kan., is the holding company for a portfolio of successful companies including YRC Freight, YRC Reimer, Holland, Reddaway, and New Penn. YRC Worldwide has one of the largest, most comprehensive less-than-truckload (LTL) networks in North America with local, regional, national and international capabilities. Through its team of experienced service professionals, YRC Worldwide offers industry-leading expertise in heavyweight shipments and flexible supply chain solutions, ensuring customers can ship industrial, commercial and retail goods with confidence. Please visit www.yrcw.com for more information.
Follow YRC Worldwide on Twitter: http://twitter.com/yrcworldwide
CONTACT: Investor Contact: Stephanie Fisher 913-696-6108 investor@yrcw.com Media Contact: Suzanne Dawson LAK Public Relations, Inc. 212-329-1420 sdawson@lakpr.com
(NIHD) Agreement with Apple to Bring iPhone to its Nextel Brazil Operations
RESTON, Va., Jan. 17, 2014 — NII Holdings, Inc. (NASDAQ: NIHD), a provider of differentiated mobile communication services operating under the Nextel brand in Latin America, today announced it will offer iPhone 5s, the most forward-thinking smartphone in the world, and iPhone 5c, the most colorful iPhone yet, to Nextel Brazil customers beginning January 31, 2014. Customers may pre-register interest today at www.nextel.com.br.
For more information, please visit www.nextel.com.br. For more information on iPhone, please visit www.apple.com/iphone.
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: nii.com/newsroom.
Media Contacts:
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
(ARQL) Provides Updates on Tivantinib Clinical Trials in Cancer
ArQule, Inc. (Nasdaq: ARQL) today provided clinical updates on the ongoing pivotal Phase 3 METIV-HCC trial in hepatocellular carcinoma (liver cancer) conducted by the Company and its partner, Daiichi Sankyo Co., Ltd., and on the completed amended Phase 3 ATTENTION trial in non-squamous non-small cell lung cancer (NSCLC) conducted in Asian territories by its partner, Kyowa Hakko Kirin Co., Ltd.
METIV-HCC Trial
The Data Monitoring Committee (DMC) of the METIV-HCC trial has recommended continuation of the ongoing pivotal Phase 3 METIV-HCC trial of tivantinib as a single agent in hepatocellular carcinoma with a lower dose of tivantinib, 120 milligrams (mg) tablets administered twice daily (BID). This decision followed the DMC’s review of data analyses from a predefined number of patients who received this lower dose.
Recently completed safety analyses among patients treated with 120 mg BID tivantinib tablets showed that the incidence of neutropenia was reduced with this lower dose. In addition, pharmacokinetic analyses from this patient cohort, reviewed by the DMC, demonstrated that the plasma exposure of the 120 mg BID tablets dose was comparable to the exposure achieved with the 240 mg BID capsules dose employed in the Phase 2 trial, with similar medians and overlapping ranges.
A dose reduction from 240 mg BID tablets to 120 mg tablets BID was implemented in September, 2013 following the observation of a higher incidence of neutropenia in the initial phase of the METIV-HCC trial than was observed in the Phase 2 trial in the same patient population where a 240 mg BID capsule dose was administered. Certain enhanced patient monitoring procedures had been temporarily instituted to confirm the safety profile of the lower dose.
The METIV-HCC trial is a pivotal randomized, double-blind study of tivantinib as single agent therapy in previously treated patients with MET diagnostic-high, inoperable HCC. The primary endpoint is overall survival in the intent-to-treat population, and the secondary endpoint is progression free survival in the same population. METIV-HCC is being conducted under a Special Protocol Assessment (SPA).
ATTENTION Trial
Kyowa Hakko Kirin has provided the Company with top-line results of the amended Phase 3 ATTENTION clinical trial evaluating the combination of tivantinib (ARQ 197) and erlotinib in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with wild-type EGFR (epidermal growth factor receptor) in Asia (Japan, Korea and Taiwan).
Enrollment in ATTENTION had been originally planned for 460 patients, and the trial’s statistical analysis plan was calibrated accordingly and remained unchanged. Recruitment of new patients was permanently suspended in October, 2012 based on a recommendation by the trial’s Safety Review Committee following an observed imbalance in interstitial lung disease (ILD) cases as a drug-related adverse event. Patients who received treatment in ATTENTION as of October, 2012 were allowed to continue thereafter in the trial after being re-consented, and including such patients, a total of 307 patients were included in the final analysis.
In the ITT population, overall survival (OS) favored the treatment arm of tivantinib plus erlotinib compared to the erlotinib only control arm, but it was not statistically significant (median OS of 12.9 months vs 11.2 months, hazard ratio = 0.89, p = 0.4). Progression free survival (PFS) and overall response rate (ORR) results also showed a numerical trend toward improvement favoring the treatment arm.
The safety profile observed in ATTENTION was in line with what had been previously observed in other NSCLC trials with tivantinib, with the exception of a reported imbalance in ILD, which is a known adverse event in Japanese patients treated with EGFR inhibitors such as erlotinib. In the Phase 3 MARQUEE trial in non-squamous NSCLC conducted in Western countries, no imbalance was observed in the incidence of ILD between treatment and control arms, with one case (0.2%) reported in the treatment arm and four cases (0.8%) in the control arm.
ATTENTION is a Phase 3 randomized, double-blind trial comparing OS of second or third line non-squamous NSCLC patients with wild-type EGFR treated with tivantinib and erlotinib to OS of patients treated with placebo and erlotinib. Complete data from this study, including biomarker analyses, are expected to be presented at a future scientific meeting.
About MET and Tivantinib (ARQ 197)
Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase, which is currently in Phase 2 and 3 clinical trials. In certain healthy adult cells, MET is present in low to normal levels to support natural cellular function, but in some cancer cells, MET is inappropriately and continuously activated. When abnormally activated, c-Met plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to EGFR inhibitors such as cetuximab.
Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.
About ArQule, Inc. and its Partners for the Development of Tivantinib
On December 19, 2008, ArQule and Daiichi Sankyo Co., Ltd. signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, areas for which Kyowa Hakko Kirin has exclusive rights for development and commercialization under an exclusive license agreement signed with ArQule in 2007.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company’s pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase and ARQ 087, designed to inhibit fibroblast growth factor receptor (FGFR). ArQule’s current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent and selective against their targets.
This press release contains forward-looking statements regarding the METIV-HCC clinical trial with tivantinib in hepatocellular carcinoma (HCC) conducted with Daiichi Sankyo and the ATTENTION clinical trial with tivantinib in combination with erlotinib in non-squamous non-small cell lung cancer conducted by Kyowa Hakko Kirin as well as the Company’s agreements with both Daiichi Sankyo and Kyowa Hakko Kirin. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that tivantinib alone or in a combination therapy will demonstrate promising therapeutic effects in pivotal or other trials; in addition, tivantinib may ultimately not demonstrate an appropriate safety profile in later stage or larger scale clinical trials, such as METIV-HCC, including among patients with underlying cirrhosis and compromised liver function, as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing tivantinib that could lead the Company, Daiichi Sankyo or Kyowa Hakko Kirin to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from analyses of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities, and regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of completion of clinical trials like METIV-HCC is subject to the ability of the Company or its partners to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome ongoing or emergent regulatory issues and address other technical hurdles and issues related to the conduct of the trials for which each of them is responsible that may not be resolved promptly, or at all. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate the tivantinib license agreement with the Company. If it were to do so, the Company might not be able to complete development and commercialization of tivantinib on its own. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.
(NLST) Expands IP of Hybrid Memory Systems
Two New Fundamental Patents Covering Hybrid DRAM / FLASH Memory Modules
IRVINE, CA–(Jan 16, 2014) – Netlist, Inc. (NASDAQ: NLST), a leading provider of high performance memory solutions for the cloud computing and storage markets, announced today that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for two of Netlist’s pending patent applications covering core aspects of hybrid memory systems that combine DRAM and FLASH memory technologies.
Hybrid memory systems combine the speed, endurance, and reliability of DRAM with the persistence, high density and low cost of FLASH. The claims contained in these new patents cover innovations critical to facilitating the movement of data between the host system and the DRAM memory and between the DRAM and FLASH memory subsystems.
“The rapidly expanding market for the fusion of memory and storage is an important area for Netlist and one where we continue to actively grow our patent portfolio,” said Netlist President and CEO, C.K. Hong. “Enterprise flash storage solutions, of which Hybrid memory modules and memory channel interface SSDs are a part of, are projected to be an $8B market by 2017. Netlist is proud to be the market leader in this transformation and we see significant opportunities for current and future products as well as patent monetization.”
Netlist has steadily invested in and grown its IP portfolio, which now includes 41 issued patents and more than 29 US and foreign pending patent applications in the areas of high performance and high density memory subsystems and hybrid memory technologies.
About Netlist:
Netlist, Inc. designs and manufactures high-performance, logic-based memory subsystems for server and storage applications for cloud computing. Netlist’s flagship products include HyperCloud®, a patented memory technology that breaks traditional performance barriers, NVvault™ and EXPRESSvault™ family of products that significantly accelerate system performance and provide mission critical fault tolerance, and a broad portfolio of industrial flash and specialty memory subsystems including VLP (very low profile) DIMMs and Planar-X RDIMMs.
Netlist develops technology solutions for customer applications in which high-speed, high-capacity, small form factor and efficient heat dissipation are key requirements for system memory. These customers include OEMs that design and build tower, rack-mounted, and blade servers, high-performance computing clusters, engineering workstations and telecommunications equipment. Founded in 2000, Netlist is headquartered in Irvine, CA with manufacturing facilities in Suzhou, People’s Republic of China. Learn more at www.netlist.com.
Safe Harbor Statement:
This news release contains forward-looking statements regarding future events and the future performance of Netlist. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. These risks and uncertainties include, but are not limited to, risks associated with the launch and commercial success of our products, programs and technologies; the success of product partnerships; continuing development, qualification and volume production of EXPRESSvault™, NVvault™, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the anticipated decrease in sales to our key customer; our ability to leverage our NVvault™ technology in a more diverse customer base; the rapidly-changing nature of technology; risks associated with intellectual property, including patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined by the United States Patent and Trademark office; volatility in the pricing of DRAM ICs and NAND; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in the Company’s and its customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; the Company’s ability to attract and retain skilled personnel; the Company’s reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; and the political and regulatory environment in the People’s Republic of China. Other risks and uncertainties are described in the Company’s annual report on Form 10-K filed on March 29, 2013, and subsequent filings with the U.S. Securities and Exchange Commission made by the Company from time to time. Except as required by law, Netlist undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please contact:
Brainerd Communicators, Inc.
Corey Kinger
Mike Smargiassi
NLST@braincomm.com
(212) 986-6667
(CYTR) Appoints Shanta Chawla, M.D. as Vice President, Clinical Development
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the appointment of Shanta Chawla, M.D. as Vice President, Clinical Development. Dr. Chawla has more than 13 years of clinical research, operations and development experience, with a focus on oncology therapeutics.
“In this new position, Dr. Chawla will play a key role in the management of our upcoming global Phase 3 clinical trial under a Special Protocol Assessment with aldoxorubicin as a second-line treatment for soft tissue sarcomas,” said CytRx Executive Vice President and Chief Medical Officer Dr. Daniel Levitt. “She has designed and managed large clinical trials in North America and Europe for a range of cancer types, and brings to CytRx a proven ability to meet enrollment targets and work within budget requirements. We are fortunate to have Dr. Chawla join our team as we move into a very exciting and demanding phase of activity.”
“I am delighted to be joining CytRx at this critical point in the company’s development, and in particular in light of the recently announced highly positive results from the global Phase 2b trial with aldoxorubicin in advanced soft tissue sarcomas,” said Dr. Chawla. “I look forward to playing a significant role in the continued development of this promising oncology therapeutic.”
From 2001 to 2013 Dr. Chawla was at Spectrum Pharmaceuticals, most recently as Vice President, Clinical Research and Development, where her expertise included selecting clinical trial sites and principal investigators, establishing protocols with the FDA and key opinion leaders, preparing FDA filings and project team management. Dr. Chawla received her M.D. from Maulana Azad Medical College in New Delhi, and performed her internship and residency in Philadelphia at Albert Einstein Medical Center and Thomas Jefferson University Hospital, respectively. She is board certified in Internal Medicine. Dr. Shanta Chawla is not related to Dr. Sant Chawla, the principal investigator in CytRx’s global Phase 3 clinical trial for soft tissue sarcoma.
About Soft Tissue Sarcoma
Soft tissue sarcoma 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 soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. 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 (3½ 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 the results of any future human testing of aldoxorubicin might not produce results similar to those 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.
(CYTR) MissionIR Interview Goes Into Details of Clinical Trial Results, Plans for Incredible 2014
ATLANTA, GA–(Jan 16, 2014) – MissionIR today announces the online availability of its interview with CytRx Corp. (NASDAQ: CYTR) President and Chief Executive Officer Steven Kriegsman, as well as the company’s vice president of business development and investor relations David Haen. The full audio interview is available at the following link: http://CYTR.MissionIR.com/interview-jan2014.html.
CytRx is a biopharmaceutical R&D company developing cancer drugs for several indications. The company’s lead candidate, aldoxorubicin, is the company’s improved formulation of widely used chemotherapy agent, doxorubicin. Phase 2b study results, released in December 2013, showed aldoxorubicin to be superior to doxorubicin by both an investigator assessment and a central lab review. Furthermore, aldoxorubicin was found to be safe and well-tolerated with no treatment-related deaths.
Speaking with MissionIR host Stuart Smith, CEO Kriegsman explained in depth the tremendous value of the results.
“We really had spectacular results in our global phase 2b clinical trial in first-line soft tissue sarcoma. And when I say ‘spectacular,’ they were highly statistically significant, not just statistically significant… we had great response rates… we saw substantial tumor shrinkage,” Kriegsman said.
The trial results triggered a triple-digit rally in CytRx stock, adding to a year of gains. As Kriegsman put it, “It was a wonderful year for CytRx, it was a wonderful year for our shareholders, but most importantly it was a wonderful year for sarcoma patients who were privileged to get aldoxorubicin rather than doxorubicin.”
Haen added that aldoxorubicin in the head-to-head study not only met the primary endpoints, it also opened the door for additional therapeutic applications.
“This data is quite robust… this really paves the way that aldoxorubicin is superior to doxorubicin. Now we can look for the next trials with soft tissue sarcoma, but we can also have greater confidence in expanding to other indications where doxorubicin is used because we’ve shown that [aldoxorubicin] is superior,” added Haen.
While 2013 was a powerful year for CytRx in many ways, Kriegsman said it “pales in comparison to what we expect to achieve in 2014,” and further embellished on upcoming events and expectations, including an agreement with the FDA, additional clinical trials, possible partnerships and other significant milestones.
About CytRx Corp.
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 is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed 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 also is initiating Phase 2 clinical trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-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 additional information, please visit the Company’s corporate Website: www.Cytrx.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.
CytRx Corp.
Los Angeles, Calif.
www.Cytrx.com
310-826-5648
info@Cytrx.com
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(GALT) IND for Its Galectin Inhibitor GR-MD-02 in Metastatic Melanoma
IND Submitted by Providence Portland Medical Center, a Leading Cancer Immunotherapy Research Institute
NORCROSS, Ga., Jan. 15, 2014 — Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that Providence Portland Medical Center filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) on December 27, 2013 to study GR-MD-02 in combination with Yervoy® (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. GR-MD-02 is Galectin Therapeutics’ proprietary molecule that binds to and inhibits galectin proteins, predominantly galectin-3.
The application was prompted by findings from a preclinical study led by tumor immunology expert William L. Redmond, Ph.D., of the Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). The preclinical study found that GR-MD-02 increased tumor shrinkage and enhanced survival in immune competent mice with prostate and breast cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a role for GR-MD-02 in cancer immunotherapy.
“The IND filing to study GR-MD-02 in conjunctive use with Yervoy in patients with metastatic melanoma is an important milestone for both Providence Portland Medical Center and Galectin Therapeutics,” said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. “Preclinical data have shown that GR-MD-02 holds immense potential for increasing the effectiveness of other therapies and may be an important approach in enhancing cancer immunotherapy.”
If the application is approved by the FDA, the Phase 1B study will be conducted by the EACRI under principal investigator Brendan D. Curti, M.D. EACRI and Providence Cancer Center researchers have been leaders in immunotherapy research and translational clinical trials in melanoma and other cancers.
“The Phase 1B study will determine if GR-MD-02 enhances the probability of melanoma response with ipilimumab by inducing proliferation, activation and memory function of CD8+ T cells,” said Dr. Curti, the trial’s principal investigator, a medical oncologist and director of the Providence Biotherapy Program at EACRI. “The combination of GR-MD-02 and ipilimumab has a strong scientific rationale based on Dr. Redmond’s laboratory work. This study represents a novel approach for patients with metastatic melanoma.”
The study will employ a 3+3 Phase 1 design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition. Galectin Therapeutics will provide its proprietary compound GR-MD-02 to EACRI researchers, as well as supply researchers with supporting analysis of the pharmacokinetics of GR-MD-02 and the right to reference the Company’s open IND on GR-MD-02.
Separately, the Cancer Centre at the Cliniques universitaires Saint-Luc and the Ludwig Institute for Cancer Research (LICR), in agreement with Galectin Therapeutics, placed on hold its Phase 1/2 trial evaluating the safety and efficacy of another galectin inhibitor, GM-CT-01, in combination with an experimental peptide vaccine for the treatment of advanced metastatic melanoma. Dr. Jean-Francois Baurain, the trial’s principal investigator, medical oncologist and director of the melanoma clinic of the Cancer Center at CUSL, said, “The trial was unable to enroll sufficient patients with advanced stage melanoma due to the high selection criteria of patient candidates for the peptide vaccine and the recent availability of Yervoy in Europe as a treatment increasing the overall survival of metastatic melanoma patients.” A total of three patients completed the trial with no serious adverse events attributed to drug treatment and with two patients having a mixed response and one having progressive disease.
YERVOY ® is a registered trademark of Bristol-Myers Squibb Company.
About Metastatic Melanoma
Melanoma, the most dangerous form of skin cancer, is one of the most widespread cancers among young adults. Metastatic melanoma occurs when the cancer cells spread (or metastasize) through the lymph nodes to other parts of the body. The liver, lungs, bones and brain are most often affected by these metastases. The American Cancer Society estimates that there were over 76,000 new diagnoses and 9,100 deaths from melanoma in the United States in 2012.
About Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute (EACRI), Providence Cancer Center, Portland Oregon
Providence Cancer Center, a part of Providence Health & Services, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. The Earle A. Chiles Research Institute at Providence Cancer Center is one of 10 research institutions selected to form the (BMS) International Immuno-Oncology Network. This global collaboration will focus on helping the body’s own immune system fight cancer and bring more clinical trials to more patients in our community than ever before.
About Galectin Therapeutics
Galectin Therapeutics (Nasdaq:GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. These statements include those regarding preclinical data and the potential role for GR-MD-02 and GM-CT-01 in the treatment of liver fibrosis and cirrhosis and cancer in humans. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding any preclinical data and potential therapeutic uses and benefits of our drugs and any future pre-clinical or clinical studies are subject to factors beyond our control. Future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of current or future studies, we may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
CONTACT: Galectin Therapeutics Inc. Peter G. Traber, MD, 678-620-3186 President, CEO, & CMO ir@galectintherapeutics.com
(ECTE) o Present at the Noble Financial Capital Markets’ 10th Annual Equity Conference
PHILADELPHIA, Jan. 15, 2014 — Echo Therapeutics, Inc. (Nasdaq: ECTE) (“Echo”), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics, will present at “TEN”, Noble Financial Capital Markets’ Tenth Annual Equity Conference.
Mr. Doman will make a corporate presentation to prospective corporate partners and investors at 9:00 AM EST on Wednesday, January 22nd. The Company’s presentation will be delivered in Sandpiper Bay, Florida.
At the time of the presentation, a live audio and high-definition video webcast of Mr. Doman’s presentation and a copy of the presentation materials will be available in the Events section of the Company’s website at www.echotx.com, or through the Noble Financial websites: www.noblefcm.com or www.nobleresearch.com/TEN/2014.htm. Echo recommends registering at least 10 minutes prior to the start of the presentation to ensure timely access. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will also be archived on www.echotx.com for 90 days following the event.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless, continuous glucose monitoring system for use initially in the critical care setting. Significant opportunity also exists for Symphony to be used in the hospital beyond the critical care setting, as well as in patients with diabetes in the outpatient setting. Echo is also developing its needle-free skin preparation component of Symphony, the Prelude® SkinPrep System, as a platform technology to enhance delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, including the statement about the corporate presentation, may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s ongoing studies, including the safety and efficacy of Echo’s Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo’s Symphony CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell the Symphony CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(215) 717-4104
colimpio@echotx.com
Connect With Us:
– Visit our website at www.echotx.com
– Follow us on Twitter at www.twitter.com/echotx
– Join us on Facebook at www.facebook.com/echotx
(DRWI) and Xi’an Potevio Strategic Sales Agreement Chinese Mobile Market
4G Market growth in The People’s Republic of China to be addressed with Horizon and Harmony packet microwave radios
OTTAWA, CANADA–(Jan. 15, 2014) – DragonWave Inc. (TSX:DWI)(NASDAQ:DRWI), a leading global supplier of packet microwave radio systems for mobile and access networks, and Xi’an Potevio Communications, an ICT subsidiary company of China Potevio Corporation, today announced the signing of a strategic sales agreement focused on the sale and distribution of DragonWave solutions in The People’s Republic of China. As part of the agreement Xi’an Potevio Communications, has made the first deliveries to a leading mobile services provider in Mainland China of Horizon Compact, all-outdoor radios and will expand its marketing of Horizon and Harmony microwave radios for use in the country’s growing mobile, fixed and enterprise markets.
“After much due diligence seeking the most reliable and efficient solutions to address the country’s growing need for carrier grade microwave solutions, we’ve selected DragonWave for its advanced technology and proven performance,” said Mr. Zhong Fu Sheng, General Manager, Xi’an Potevio Communications. “The combined Horizon and Harmony portfolio allows us to address any number of deployment scenarios needed to advance and maintain exceptional service and to meet growing capacity demands across a broad range of markets.”
Xi’an Potevio is an ISO9001 and ISO14001 certified company. Its main product line include: a microwave parabolic communications antenna, base station communications antenna, satellite communications antenna, grid parabolic communications antenna, microwave communications passive repeater, indoor distributed antenna and 3.5 GHz wireless access antenna. The company distributes its products in over 30 provinces, cities and autonomous regions, and they are also widely applied to many national and provincial trunks and various professional communications networks, such as China Telecom, China Mobile, China Unicom, CNC, Electric Power network, Broadcasting and Television organization, Public Security, Military, etc.
“The 4G deployment in The People’s Republic of China represents a significant and important market for us and we’re pleased to enter into this agreement with Xi’an Potevio to bring DragonWave solutions into play to address a large and rapidly expanding communications infrastructure,” said Peter Allen, DragonWave President and CEO. “We look forward to our ongoing collaboration that will allow Xi’an Potevio to provide packet microwave solutions with the best performance, at the lowest cost, for a wide variety of deployments across the country.”
DragonWave’s Horizon and Harmony product portfolios are designed to meet the network requirements of new and evolving 2G, 3G and 4G networks. DragonWave’s products are point-to-point packet and Hybrid radios providing scalable, ultra-low latency, native packet and TDM connectivity up to 1.6 Gbps full duplex in 6 to 60GHz frequencies supporting ring and mesh architectures for carrier grade delivery of next generation IP services. DragonWave’s solution offers unprecedented scale, improved economics and simplified operations.
About Xi’an Potevio
Xi’an Potevio a subsidiary company of China Potevio Corporation is a joint-stock high-tech enterprise specializing in the field of R&D, manufacturing, sales, installation and services of microwave, mobile, satellite communication antennas and related communications products. It is the first professional antenna manufacturer in China and one of three biggest microwave antenna manufacturers throughout the world.
Potevio.Com Community: http://www.potevio.com/en/tabid/279/language/zh-CN/Default.aspx
About DragonWave
DragonWave® is a leading provider of high-capacity packet microwave solutions that drive next-generation IP networks. DragonWave’s carrier-grade point-to-point packet microwave systems transmit broadband voice, video and data, enabling service providers, government agencies, enterprises and other organizations to meet their increasing bandwidth requirements rapidly and affordably. The principal application of DragonWave’s portfolio is wireless network backhaul, including a range of products ideally suited to support the emergence of underlying small cell networks. Additional solutions include leased line replacement, last mile fiber extension and enterprise networks. DragonWave’s corporate headquarters is located in Ottawa, Ontario, with sales locations in Europe, Asia, the Middle East and North America. For more information, visit http://www.dragonwaveinc.com.
DragonWave® and Horizon® are registered trademarks of DragonWave Inc.
Forward-Looking Statements
Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements as to DragonWave’s growth opportunities and the potential benefits of, and demand for, DragonWave’s products. These statements are subject to certain assumptions, risks and uncertainties, including our view of the relative position of DragonWave’s products compared to competitive offerings in the industry. Readers are cautioned not to place undue reliance on such statements. DragonWave’s actual results, performance, achievements and developments may differ materially from the results, performance, achievements or developments expressed or implied by such statements. Risk factors that may cause the actual results, performance, achievements or developments of DragonWave to differ materially from the results, performance, achievements or developments expressed or implied by such statements can be found in the public documents filed by DragonWave with U.S. and Canadian securities regulatory authorities. DragonWave assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Nadine Kittle
Marketing Communications
DragonWave Inc.
nkittle@dragonwaveinc.com
613-599-9991 ext 2262
Russell Frederick
CFO
DragonWave Inc.
rfrederick@dragonwaveinc.com
613-599-9991 ext 2253
Becky Obbema
Interprose Public Relations
(for DragonWave)
Becky.Obbema@interprosepr.com
(408) 778-2024
(HOTR) Executes Agreement and Plan of Merger to Acquire Spoon Bar & Kitchen
CHARLOTTE, NC–(Marketwired – January 15, 2014) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or “the Company”), headquartered in Charlotte, North Carolina, announced today that the Company has executed an Agreement and Plan of Merger to acquire Spoon Bar & Kitchen through the purchase of all of the outstanding shares of Dallas Spoon, LLC and Dallas Spoon Beverage, LLC. Once the transaction is finalized, Dallas Spoon and Dallas Spoon Beverage will be subsidiaries of the Company.
Spoon Bar & Kitchen is a fine dining seafood restaurant by Chef John Tesar. The restaurant has received numerous awards from national publications including Conde Nast, Bon Appetite, and Esquire Magazine. Chanticleer intends to expand the Spoon brand into a new, fast-casual dining concept.
Mike Pruitt, CEO and President of Chanticleer Holdings commented, “We are excited to complete this acquisition. As we begin our 2014 growth strategy, we believe the Spoon brand has the appeal that today’s consumers are looking for in a cutting-edge, wholesome seafood menu. We look forward to expanding the brand with the culinary knowledge of Chef Tesar.”
The terms of the agreement calls for Chanticleer to issue 195,000 HOTR units to Express Working Capital, L.L.C., the parent company of Dallas Spoon and Dallas Spoon Beverage. Each unit consists of one share of the Company’s common stock, and one five-year warrant, 97,500 of which are exercisable at $5.50 and 97,500 exercisable $7.00. The value of the share exchange will be dependent upon Chanticleer Holding’s stock price at date of closing. Final closing is anticipated on or before January 31, 2014.
About Spoon Bar & Kitchen
Spoon Bar & Kitchen is a fine dining seafood restaurant by James Beard nominated chef John Tesar. Spoon offers several unique dining experiences. Expect a built-in raw bar offering two selections of oysters per night, a semi-private wine room with a chef’s table, and an interactive counter overlooking the open kitchen where diners can sample experimental cuisine. The menu focuses on responsibly sourced seafood using the highest quality ingredients. Patrons can choose from the a la carte menu or opt for a chef’s tasting menu that changes nightly. The interior, designed by Breckenridge Taylor, exudes the feeling of a seaside bistro with modern accents. The 58-seat dining room features textured plaster walls, antique mirrors, rounded banquettes and a sleek marble bar. Located at 8220-B Westchester Drive, Spoon is open for dinner Tuesday through Thursday from 5 p.m. to 10 p.m., Friday through Saturday from 5 p.m. to 11 p.m., and Sunday from 5 p.m. to 10 p.m. The restaurant is open for lunch Tuesday through Friday from 11 a.m. to 2 p.m. For reservations and more information, please visit www.spoonbarandkitchen.com.
About Chanticleer Holdings, Inc.
Chanticleer Holdings (NASDAQ: HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee 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 continues to evaluate 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.
Contact:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com
(ATNM) Announces Engagement of MissionIR Investor Relations Services
ATLANTA, GA–(Jan 15, 2014) – Actinium Pharmaceuticals, Inc. (OTCQB: ATNM) (the “Company”) today announces that they have engaged the investor relations services of MissionIR. Through a network of investor-oriented sites and full suite of investor awareness services, MissionIR broadens the influence of publicly traded companies and enhances their ability to attract growth capital as well as improve shareholder value.
“Actinium is wrapping up a year of tremendous progress in the development of its cancer treatment candidates, and is on the cusp of initiating additional clinical trials,” stated Sherri Franklin, Director of Marketing at MissionIR. “MissionIR is pleased to partner with the Company as it starts off a new year of advances with a firm stance and high potential in the biotech industry.”
Actinium intends to develop its cancer treatment products through clinical trials and then intends to partner each drug for completion of development and commercialization with an appropriate third party. In working toward this objective, the Company aims to increase brand awareness.
“We’re moving closer to the commercialization of our cancer drugs, and want to increase visibility in the investment community and enhance communication with our existing shareholders along the way,” Dr. Kaushik J. Dave, President and CEO of Actinium, stated. “Engaging a full-service investor relations firm will help us develop and implement a strategic investor relations campaign to reach this goal. MissionIR is providing a much needed service in the small-cap markets.”
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. Through a full suite of investor relations and consultancy services, we help public companies develop and execute a strategic investor awareness plan as we’ve done for hundreds of others. Whether it’s capital raising, increasing awareness among the financial community, or enhancing corporate communications, we offer a variety of solutions to meet the objectives of our clients.
For more information, visit www.MissionIR.com
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company that develops innovative alpha particle immunotherapeutics based on its proprietary platform for the therapeutic utilization of alpha particle emitting actinium-225 and bismuth-213 radiopharmaceuticals in association with monoclonal antibodies.
For more information, visit www.ATNM.MissionIR.com
Forward-Looking Statements
This Press Release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect the Company’s current beliefs and are based upon information currently available to it. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance or achievements to differ materially from those expressed in or implied by such statements. The Company undertakes no obligation to update or advise in the event of any change, addition or alteration to the information included in this Press Release including such forward-looking statements.
Contact:
Mission Investor Relations
Sherri Franklin
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(TSLA) Revenue Expected to Exceed Guidance by 20% in Fourth Quarter
Sales Driven by Superlative Safety Record and Excellent Cold Weather Performance
PALO ALTO, CA–(Jan 14, 2014) – Tesla (NASDAQ: TSLA) sales in the fourth quarter of 2013 were the highest in company history by a significant margin. With almost 6,900 vehicles sold and delivered, Tesla exceeded prior guidance by approximately 20%. A higher than expected number of cars was manufactured as a result of an excellent effort by the Tesla production team and key suppliers, particularly Panasonic.
The two key drivers of demand were the superlative safety record of the Model S and great performance under extremely cold conditions.
Safety Record
Tesla remains the only manufacturer with a perfect safety record of zero deaths or serious, permanent injuries ever. Including the Roadster, Tesla vehicles have now been on the road for almost six years in 31 countries with almost 200 million miles driven to date. Despite dozens of high speed collisions, the driver and passengers have always been protected. This is Tesla’s proudest achievement.
Independent testing by the National Highway Traffic Safety Administration (NHTSA) awarded the Tesla Model S a 5 star safety rating overall and in every subcategory without exception. Of all vehicles tested, including every major make and model approved for sale in the United States, the Model S set a new record for the lowest likelihood of injury to occupants. While the Model S is a sedan, it also exceeded the safety score of all SUVs and minivans.
Excellent Cold Weather Performance
Due to the precision of its electric powertrain, the Model S has outstanding traction control relative to the much higher latency and inertia of a gasoline powertrain. As a result, it is able to perform better on snow and ice than many all-wheel drive gasoline cars, as shown in this Tesla produced video:
http://www.youtube.com/watch?v=GS9uDJGi52A
And many independent reviews and customer produced videos:
http://www.youtube.com/results?search_query=tesla%20cold%20weather&sm=3
Tesla’s highest sales per capita are in Norway and the individual customer who owns the most cars lives in Narvik, which is above the Arctic Circle.
Press Contact
Tesla Motors, Inc.
Email Contact
(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.
(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
(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.
(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
(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.
(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 |
(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.
(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.
(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.
(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
(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.
(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
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