Uncategorized
(ARWR) Completes Enrollment Phase 1 Study of ARC-520 in Chronic Hep-B
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it completed enrollment in a Phase 1 clinical trial of ARC-520, its RNAi-based candidate against chronic hepatitis B virus infection. Initial data indicate that ARC-520 is generally safe and well tolerated at all six dose levels studied, enabling the company to proceed with plans to initiate a Phase 2a pilot efficacy study in chronic HBV patients.
“We are very pleased with these results and the pace at which we were able to complete the Phase 1 study. This positive readout on safety and tolerability of ARC-520 and the Dynamic Polyconjugate (DPC) delivery platform has broad implications for Arrowhead. It gives us additional confidence as we move into an upcoming Phase 2a study and we believe it represents a key de-risking event for expanding our pipeline of RNAi therapeutics based on the DPC platform,” said Christopher Anzalone, Ph.D., President and Chief Executive Officer.
The Phase 1 trial was designed to characterize the safety profile of ARC-520 across a range of doses and evaluate pharmacokinetics. It is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers. All subjects have been dosed and received either placebo or ARC-520 in doses ranging from 0.01 mg/kg to 2 mg/kg.
The study was planned to enroll 36 subjects in six cohorts of six subjects each, with 2 subjects receiving placebo and 4 receiving ARC-520. The study successfully enrolled all 36 subjects (24 received ARC-520, 12 placebo) at a single center in Melbourne, Australia. All subjects received their full, assigned dose and there were no discontinuations for adverse events or otherwise.
Based on pre-clinical studies, including GLP toxicology, it is expected that if any clinically significant or dose-limiting toxicities were to occur, they would be observed within the first 24-48 hours after administration, and would be apparent in elevations in blood chemistries. The anticipated organs of interest for potential toxicity and the resultant chemistries are liver (ALT), kidney (creatinine, urea), and muscle (CK, AST, LDH, Troponin I). In this Phase 1 study, laboratory results have not indicated any organ toxicity involving the liver, kidney, or muscle in any subject.
There have been no serious or severe adverse events reported in any subject. Overall, adverse events have been consistent with those typically seen in normal volunteer studies, including in placebo subjects. The most common events reported were upper respiratory infection (7), which were not unexpected as the trial was enrolled during the Australian winter, and headache (7). The only other events reported in more than one subject were mild lightheadedness (2), which were not accompanied by any changes in vital signs, laboratories or physical examinations. One subject developed an urticarial rash with no other physical findings, and was treated successfully with anti-histamine. Adverse events appear to have been randomly scattered across all six dosing groups with no apparent dose-related increases in occurrence rate or severity with the possible exception of mild lightheadedness. Both subjects with mild lightheadedness were in the 2 mg/kg group. Laboratory abnormalities have occurred sporadically across groups and time points pre- and post-dosing. None of these indicate any organ toxicity and the frequency and severity do not appear to be dose-related.
The study remains blinded and follow-up is ongoing. Arrowhead intends to report additional data including pharmacokinetics and relative occurrence rates for adverse events in placebo and ARC-520 treatment groups at an appropriate venue when those data become available. The company plans to use the blinded analysis available now to move forward with a filing seeking approval to proceed with a Phase 2a trial in Hong Kong.
About ARC-520
Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally. Arrowhead’s RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the point of DNA transcription, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead’s DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. In a chimpanzee chronically infected with HBV and high viremia and antigenemia, ARC-520 induced rapid reductions of 90-95% in HBV DNA, e-antigen, and s-antigen. Arrowhead has completed enrollment in a phase 1 single ascending dose study in normal volunteers, which the company expects to follow with a phase 2a study in chronic HBV patients.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary drug delivery technologies to develop targeted drugs based on the RNA interference mechanism that efficiently silence disease-causing genes. Arrowhead technologies also enable partners to create peptide-drug conjugates that specifically home to cell types of interest while sparing off-target tissues. Arrowhead’s pipeline includes clinical programs in chronic hepatitis B virus and obesity and partner-based programs in oncology.
For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company’s email list to receive news directly, please send an email to ir@arrowres.com
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
(JMSN) Closes Series A Bridge Financing
LAS VEGAS, NV–(Oct 8, 2013) – Jameson Stanford Resources Corp. (OTCQB: JMSN) (the “Company”), an emerging metals and minerals exploration and development company, announced that it has closed $500,000 of Series A Convertible Promissory Notes, due September 15, 2015.
The notes are secured by the Company’s mining claims and mineral leases related to the Chopar Mining Property, Star Mountain Mining District, located in Beaver County, Utah. The proceeds of this financing will be used primarily to fund the Company’s ongoing mineral exploration activities and for general working capital purposes. Jameson Stanford may also issue up to an additional $1,000,000 of Series B Convertible Promissory Notes on similar terms.
“This funding provides the Company with immediate capital to advance exploration efforts at our Star Mountain project as well as for general working capital,” said Michael Stanford, president and chief executive officer of Jameson Stanford Resources. “We are confident that our minerals exploration activities on our Chopar Mine claims will allow us to begin operations in late 2013. We are continuing to ramp up our exploration activities as we secure financing.”
About Jameson Stanford Resources Corp.
Jameson Stanford Resources is focused on developing significant mining claims, mineral leases and excavation rights for projects located in historic mining districts and other sites in central and southwestern Utah. The Company is presently engaged in exploration activities in connection with copper, gold, silver and base metals properties located in historic mining districts in Beaver County and Juab County, Utah. In addition, Jameson Stanford Resources has acquired excavation rights and special permitting related to deposits of alluvial minerals and silica sand located in Weber County, Utah.
Safe Harbor Forward-Looking Statements
In connection with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Jameson Stanford Resources Corporation, is hereby providing cautionary statements identifying important factors that could cause our actual results to differ materially from those projected in forward-looking statements (as defined in such act). Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “intends,” “plans,” “believes” and “projects”) may be forward-looking and may involve estimates and uncertainties which could cause actual results to differ materially from those expressed in the forward-looking statements. These statements include, but are not limited to, our expectations concerning the presence of minerals and our ability to mine and process minerals commercially at a profit.
We caution that the factors described herein could cause actual results to differ materially from those expressed in any forward-looking statements we make and that investors should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors emerge from time to time, and it is not possible for us to predict all of such factors. Further, we cannot assess the impact of each such factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Contact:
Jameson Stanford Resources Corp.
Las Vegas, NV
www.JamesonStanford.com
702-933-0808
IR@JamesonStanford.com
Mission Investor Relations
Atlanta, GA
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(CYTR) New Aldoxorubicin Data Demonstrates Significant Advantages over Doxorubicin
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced compelling preliminary data from its global Phase 2b soft tissue sarcoma trial indicating that patients treated with aldoxorubicin had a significantly higher OVERALL RESPONSE RATE (ORR) of 22% as compared to those administered the widely used chemotherapeutic agent doxorubicin with an ORR of 0%.
Additionally, aldoxorubicin compared with doxorubicin produced statistically significant improvement in survival rates in animals with a human model of glioblastoma (brain tumor), and showed an improved and narrow distribution of aldoxorubicin within the human body in a pharmacokinetics trial. Results from the glioblastoma trial and pharmacokinetics trial were discussed in poster presentations at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO) being held in Amsterdam, Netherlands.
“We are compiling an ever-increasing portfolio of impressive human and pre-clinical data that aldoxorubicin could have an essential role in the treatment of patients with a wide range of cancers,” said CytRx President and CEO Steven A. Kriegsman. “This collective body of data gives us tremendous hope that we will be able to make an important difference in the lives of cancer patients worldwide. This data also supports our belief in the potential benefit of our linker technology platform to one day form the basis of a multi-billion dollar revenue oncology franchise with drugs to treat a wide range of cancers.
“Given the promising prospects for aldoxorubicin, we are aggressively moving forward with its clinical development,” he added. “We recently received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a very difficult-to-treat and deadly cancer, and also plan to conduct a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma.”
Increased Responses Show OVERALL RESPONSE RATE of 22% in Global Phase 2b Trial in Advanced Soft Tissue Sarcoma
Preliminary data from the Phase 2b clinical trial directly comparing aldoxorubicin with doxorubicin as a first-line treatment for patients with metastatic, locally advanced or unresectable soft tissue sarcomas showed that aldoxorubicin-treated patients demonstrated a significantly greater percentage of overall responses compared with those treated with doxorubicin, the current standard-of-care for advanced, metastatic soft tissue sarcoma. This was based on a blinded reading of tumor scans by an independent radiology review. In this trial, aldoxorubicin was safely delivered at 3.5 times the dose level of doxorubicin in the comparator arm. The overall response data, which were reviewed on a blinded basis by independent radiologists, are as follows:
82 Evaluated Patients | ||||||||||||||||||||||
58 aldoxorubicin-treated | 24 doxorubicin-treated | |||||||||||||||||||||
Number | Percentage | Number | Percentage | |||||||||||||||||||
Partial response | 13 | 22% | 0 | 0% | ||||||||||||||||||
Stable disease | 27 | 46% | 11 | 46% | ||||||||||||||||||
Responses were evaluated using the RECIST 1.1 criteria. Partial responses are defined as at least a 30% shrinkage in the sum of the longest diameters of target tumors with no increase in non-target tumors or development of new tumors. Stable disease is defined as less than a 20% increase in the longest diameter of target tumors with no increase in non-target tumors or development of new tumors.
“The magnitude of the clinical response difference supports our belief that aldoxorubicin could fill an important medical need in patients with advanced soft tissue sarcoma,” said Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D. “Although preliminary, we are certainly optimistic about aldoxorubicin’s prospects in soft tissue sarcoma based on the favorable results from our earlier second-line Phase 1b/2 clinical trial in patients who had failed other therapies and these preliminary overall response results as a first-line treatment announced today. The study is ongoing and many of the patients with tumor responses and stable disease are still receiving treatment.” The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013.
Significantly Increased Survival with Excellent Safety Profile in Glioblastoma Model
CytRx announced additional data from a trial in immunodeficient mice transplanted with human glioblastoma cells in their brain that showed those animals treated with aldoxorubicin had a median survival rate of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline.
“We saw clear evidence of drug concentration inside tumors growing in the brain and significant tumor regression in aldoxorubicin-treated animals, where doxorubicin did not appear to enter the tumor to any significant degree and showed virtually no efficacy in the treatment of these brain tumors,” said Om Prakash, Ph.D., the study’s principal investigator and poster presenter at ESMO. “Aldoxorubicin significantly reduced the number of dividing cells within the brain tumors in this trial and showed a statistically relevant increased expression of apoptosis or cell death markers. The combined results of this trial are significant as glioblastoma is the most common and aggressive of the adult brain tumors with a median survival of 12-14 months despite aggressive treatment.” Dr. Prakash is Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University (LSU) Health Sciences Center, New Orleans.
FDA Agreement for Phase 2 Clinical Trial in Glioblastoma
“We have reached an agreement with the FDA to enroll up to 28 patients in a Phase 2 clinical trial to evaluate the preliminary efficacy and safety of aldoxorubicin in patients with unresectable glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and with the drug temozolomide. I am pleased to announce that the John Wayne Cancer Center in Santa Monica, Calif.; City of Hope in Duarte, Calif.; and the LSU Cancer Center in New Orleans have agreed to participate in this trial,” stated Dr. Levitt. The trial is set to commence this year with preliminary results expected in the third quarter of 2014. “The strong survival, tumor regression and safety evidence from this study provides more than sufficient rationale to move into clinical development of aldoxorubicin for the treatment of patients suffering from this devastating cancer,” Dr. Levitt added.
Phase 2 Clinical Trial in AIDS-related Kaposi’s Sarcoma
CytRx announced plans to initiate a Phase 2 clinical trial in 2013 evaluating the preliminary efficacy of aldoxorubicin in patients with AIDS-related Kaposi’s sarcoma, a common HIV-associated tumor. The current standard-of-care for severe dermatological and systemic Kaposi’s sarcoma is liposomal doxorubicin (Doxil®); however, a significant proportion of patients exhibit minimal to no clinical response to this agent and the drug’s toxicity often prevents continued therapy. The Phase 2 trial will enroll up to 30 patients and will be conducted at the LSU Health Science Center in New Orleans.
“The key to this trial is that Kaposi’s sarcoma usually manifests as skin lesions. We have the opportunity to biopsy these lesions as the trial progresses and to collect important information about the accumulation of aldoxorubicin at the tumor site,” said Dr. Levitt.
Better, Safer Distribution of Aldoxorubicin in Cancer Patients
CytRx announced in its poster presentation at ESMO that additional data from a Phase 1b clinical trial at the Cedars Sinai Medical Center in Beverly Hills, Calif., evaluating the pharmacokinetics and safety of aldoxorubicin in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies clearly demonstrate that aldoxorubicin has circulating half-life of approximately 20-24 hours with narrow volume of distribution to healthy tissue and slow clearance from the circulation. Doxorubicin has a significantly shorter half-life and a much wider distribution in normal, healthy tissues in cancer patients than aldoxorubicin. In this study, treatment with aldoxorubicin has extended past 13 cycles (a cycle is 21 days).
“We found that only trace amounts of either free doxorubicin or its major metabolite, doxorubicinol, were detectable in the blood stream even over multiple cycles of administration,” said Dr. Levitt. “The long circulating half-life, slow clearance and narrower volume of distribution of aldoxorubicin provide insights into its ability to safely deliver higher levels of agent to tumors and not normal, healthy tissues compared with doxorubicin.”
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. It is associated with many side effects–especially the potential for damage to the 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 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 the heart muscle, even at cumulative doses of drug well over 2 grams/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline 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. The Company plans to initiate a Phase 3 global pivotal trial under a special protocol assessment (SPA) 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 Kaposi’s sarcoma. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company 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), plans to seek a partner for further development of bafetinib, and is evaluating further development of tamibarotene. 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 conclusion of the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response results similar to the preliminary data described in this press release, or might not correlate with the trial’s primary endpoint of progression-free survival, 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.
(CTIC) FDA Grants Special Protocol Assessment of Pacritinib in Myelofibrosis
– PERSIST-2 trial expected to initiate in fourth quarter of 2013 –
SEATTLE, Oct. 7, 2013 — Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the planned pivotal Phase 3 clinical trial, known as the PERSIST-2 trial, evaluating pacritinib compared to best available therapy, including approved JAK2 inhibitors such as ruxolitinib, in patients with myelofibrosis whose platelet counts are <100,000/uL. The SPA is a written agreement between CTI and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application (NDA) submission. The PERSIST-2 trial is the second of two planned Phase 3 clinical trials in patients with myelofibrosis. CTI expects to initiate the PERSIST-2 clinical trial in the fourth quarter of 2013.
“The FDA worked closely with us to achieve SPA agreement during first cycle review of the PERSIST-2 trial protocol for pacritinib,” stated James A. Bianco, M.D., CTI’s President and CEO. “As a result of the SPA, which established agreement on trial design to support regulatory approval, we expect that we will be able to initiate this pivotal Phase 3 clinical trial of pacritinib by the end of the year. Myelofibrosis is a chronic disease and JAK inhibitors have had a dramatic impact on the lives of people living with myelofibrosis. Data from earlier studies of pacritinib showed a clinically meaningful improvement in symptoms with minimal suppression of platelets or red blood cells. We believe patients with myelofibrosis, particularly those with low platelet counts, could benefit from new treatment options.”
PERSIST-2 is a 300 patient randomized, open-label, multi-center pivotal trial in patients with myelofibrosis whose platelet counts are <100,000/uL. The trial will evaluate pacritinib as compared to best available therapy, including approved JAK2 inhibitors that are dosed according to the product label for myelofibrosis patients with thrombocytopenia. Patients will be randomized (1:1:1) to receive 200 mg pacritinib twice daily, 400 mg pacritinib once daily or best available therapy. The agreed upon co-primary endpoints are the percentage of patients achieving a 35 percent or greater reduction in spleen volume measured by MRI or CT at 24 weeks of treatment and the percentage of patients achieving a Total Symptom Score (TSS) reduction of 50 percent or greater using six key symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MF-SAF) diary. The trial is expected to enroll patients at clinical sites in the United States, Europe and Australia.
Pacritinib Development Strategy
Based on pacritinib’s efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for myelofibrosis patients by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial, as described above, which is expected to begin in the fourth quarter of 2013.
In January 2013, CTI initiated PERSIST-1, which is a 270 patient randomized, open-label, multicenter Phase 3 trial comparing the efficacy and safety of pacritinib with that of best available therapy in patients with myelofibrosis. Best available therapy includes any physician-selected treatment other than JAK inhibitors and there is no exclusion by patient platelet count. The trial is currently enrolling patients at clinical sites in Europe, Australia, Russia and the United States. More details on the PERSIST-1 study can be found at www.clinicaltrials.gov.
About Pacritinib
Pacritinib is an oral tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FLT3. The JAK family of enzymes are a central component in signal transduction pathways, which are critical to normal blood cell growth and development as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood related cancers including myeloproliferative neoplasms, leukemia and lymphoma. Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anemia than has been seen in currently approved and in-development JAK inhibitors.
About Myelofibrosis
Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder. Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain.
About Cell Therapeutics, Inc.
CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding CTI’s expectations with respect to the development of CTI and its product and product candidate portfolio, the expected commencement of the PERSIST-2 clinical trial in the fourth quarter of 2013, the expected efficacy and potential benefits of pacritinib and the expectations concerning enrollment locations for the PERSIST-2 clinical trial. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that CTI may not obtain reimbursement for PIXUVRI in certain markets in the European Union as planned, that the conditional marketing authorization for PIXUVRI may not be renewed, that the second Phase 3 clinical trial of pacritinib will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.
Contacts:
Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com
Ed Bell
+1 206-282-7100
ebell@ctiseattle.com
In Europe:
CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 89659706
lvilla@cti-lifesciences.com
CTI_EUInvestors@CTI-Lifesciences.com
(CRME) Publication of Positive Data of Study On BRINAVESS
VANCOUVER, Oct. 7, 2013 – Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced publication of positive data from an observational, retrospective study performed at the Skåne University Hospital in Malmö, Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients who received 355 BRINAVESS™ treatments during the period between January 15, 2011 and April 15, 2013. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes. Conversion efficacy was 76% in patients with AF duration <10 hours. The median time spent in the ER for patients who converted on BRINAVESS was 6.5 hours. These results are published in the October 2013 issue of The European Journal of Cardiovascular Medicine.
“It is exciting to see that patients treated in the clinically critical first 48 hours after AF onset appear to continue to derive better-than-expected benefit from BRINAVESS and that they also prefer this therapy over DC cardioversion,” stated William Hunter, M.D., Chief Executive Officer of Cardiome Pharma Corp. “The high conversion efficacy coupled with short hospital stay we believe makes BRINAVESS a practical option for physicians and patients who value rapid relief from AF.”
“Skåne University Hospital developed a “fast-track” AF program in the emergency room where patients with short duration AF were promptly treated with BRINAVESS, which likely contributed to the higher efficacy seen in this setting compared to the ACT and AVRO clinical trials,” stated Dr. Steen Juul-Möller, the study’s Principal Investigator and Cardiome’s Medical Director. “The finding that 75% of successfully treated BRINAVESS patients remained in normal sinus rhythm after a one year follow-up period – was an extremely interesting and important finding that requires further investigation,” added Dr. Juul-Möller.
Patients with recent-onset AF and whom cardioversion was considered were evaluated for BRINAVESS treatment. Over the period of the study, 251 patients received 355 treatments. In all patients, 70% of BRINAVESS treatments were successful and 70% of the patients responded at least once with conversion to sinus rhythm. The conversion rate was higher at 76% among patients with AF duration <10 hours compared to 66% in those with AF >10 hours (P<0.05). Transient bradycardia and hypotension were seen in 5 patients (1.4%) occurring within minutes after conversion and were judged as a response to the change in heart rhythm. No ventricular tachyarrhythmias, including Torsade-des-Pointes were seen.1
Those patients who did not respond to BRINAVESS treatment were subsequently treated with DC cardioversion. All patients who had experienced both BRINAVESS and DC cardioversion were given a questionnaire to assess cardioversion preference and were followed up for a maximum period of 27 months (BRINAVESS [n = 156]; DC cardioversion [n=91]). Among those who converted with BRINAVESS, 72% would prefer this treatment, in patients who did not convert with BRINAVESS, 61% said they would prefer DC cardioversion if they experienced a relapse (P<0.001). Furthermore, among BRINAVESS responders, 78% were satisfied or very satisfied with the treatment. In the follow up portion of the study, after 12 months, 75% of BRINAVESS responders were still in sinus rhythm, compared to 45% of patients that required DC cardioversion (P<0.001).
References:
- Juul-Möller, S. Vernakalant in recently developed Atrial Fibrillation: How to translate pharmacological trials into clinical practice. European Journal of Cardiovascular Medicine. Vol. 2, Issue 4. Published online October 4, 2013.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2013 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
(ANV) Record Gold Production and Sales in the Third Quarter of 2013
Commissioning New 21,500 Gallons per Minute Capacity Merrill-Crowe Plant
RENO, NEVADA–(Oct. 7, 2013) – Allied Nevada Gold Corp. (“Allied Nevada”, “we”, “us”, “our” or the “Company”) (TSX:ANV) (NYSE MKT:ANV) is pleased to announce that it has achieved its metal production and sales expectations in the third quarter of 2013. The Hycroft mine (“Hycroft”) produced a record 52,198 ounces of gold and 184,070 ounces of silver in the third quarter of 2013 and we sold a record 52,713 ounces of gold and 184,082 ounces of silver. We believe that we are on track to achieve full year production and sales guidance of 175,000 – 200,000 ounces of gold and 0.9 million – 1.1 million ounces of silver in 2013.
“I am very pleased with the progress being made at site by the new operating team. While I fully expected them to turn the operation around, I am impressed with the speed and efficiency with which they have been able to improve production,” commented Randy Buffington, President and CEO of Allied Nevada. “This is a first-rate team with the systems, discipline and determination that give us the confidence that we can continue to move forward with building a world-class operation.”
Processing operations at Hycroft have improved significantly in the third quarter. Pumping capacity and fresh water availability have increased to meet processing requirements and total solution flows to the leach pads are now averaging 22,000 gallons per minute (“gpm”), an increase of 36% from the beginning of the third quarter. The new 21,500 gpm Merrill-Crowe plant began commissioning at the end of the third quarter. Initially, about 7,000 gpm will be processed through the plant with staged increases planned each week until the plant is fully commissioned and capable of processing 21,500 gpm, which is expected by the end of October. Once fully commissioned, we will discontinue use of the old Merrill-Crowe plant and carbon columns. The silver sales ratio is expected to increase with the exclusive use of the new Merrill-Crowe plant from current levels of approximately 3.5 ounces of silver for each ounce of gold produced to in excess of 6:1.
Lewis leach pad remediation is ongoing with all permits in place to begin introducing solution into wells drilled into dry areas of the pad. Testing has begun which will determine the rate and speed of recovery and solution penetration to better predict the timing of metal production from the pad. No production from these areas is factored into our 2013 or 2014 projections.
Loading of the North leach pad began on May 7, 2013, with the first solution being introduced to the pad ahead of schedule on May 15, 2013. In the five months of operation, the North leach pad has performed as predicted based on our recovery curves. Construction of the gyratory crusher has progressed well and we expect the crusher to be commissioned in the fourth quarter, as planned.
Positive initial results from the ongoing oxidation test program of Hycroft sulfide concentrate were announced in August 2013. These results indicate that viable solutions exist for oxidizing and processing concentrate onsite. We have begun the second phase of testing, led by M3 Engineering and Technology (“M3”), based in Tucson, Arizona, who were selected based on their past successes and familiarity with our milling flow sheet and the oxidation techniques being assessed. We believe that M3 will complete a prefeasibility study for the oxidation circuit by the end of 2013. The plan is for M3 to then immediately move into completing a feasibility study incorporating the oxidation work with all engineering completed to date on the milling circuit. The feasibility is expected to be completed by the end of the third quarter of 2014.
We expect to provide third quarter financial results during the week of November 4, 2013. A conference call and Q&A session will follow the release, details and timing of which will be announced shortly.
Cautionary Statement Regarding Forward Looking Information
This press release contains forward-looking statements within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934 (and the equivalent under Canadian securities laws) and the Private Securities Litigation Reform Act, that are intended to be covered by the safe harbor created by such sections. Statements that are not historical fact are forward-looking statements. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “may,” “will,” “would,” “could,” “should,” “seeks,” or “scheduled to,” or other similar words, or the negative of these terms or other variations of these terms or comparable language, or by discussion of strategy or intentions. Such forward-looking statements include, without limitation, statements regarding expectations regarding gold and silver recovery; delays in processing gold and silver; anticipated sales, costs and project economics; the results and timing of metallurgical test work, prefeasibility and feasibility studies; the realization, scope, size and capital requirements of expansion and construction activities and the timing thereof; reserve estimates; future business strategy, plans and goals and other statements that are not historical facts.
Forward-looking statements address activities, events or developments that Allied Nevada expects or anticipates will or may occur in the future, and are based on current expectations and assumptions. Although Allied Nevada management believes that its expectations are based on reasonable assumptions, it can give no assurance that these expectations will prove correct. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, among others, risks that Allied Nevada’s exploration and property advancement efforts will not be successful; risks and uncertainties inherent to its Hycroft project expansion, risks relating to fluctuations in the price of gold and silver; the inherently hazardous nature of mining-related activities; uncertainties concerning reserve and resource estimates; uncertainties relating to obtaining approvals and permits from governmental regulatory authorities; and availability and timing of capital for financing the Company’s exploration and development activities, including the uncertainty of being able to raise capital on favorable terms or at all; as well as those factors discussed in Allied Nevada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including Allied Nevada’s latest Annual Report on Form 10-K and its other SEC filings (and Canadian filings) including, without limitation, its latest Quarterly Report on Form 10-Q (which may be secured from us, either directly at the SEC website at www.sec.gov). The Company does not intend to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.
Allied Nevada Gold Corp.
Randy Buffington
President & CEO
(775) 358-4455
Allied Nevada Gold Corp.
Tracey Thom
Vice President, Investor Relations
(775) 789-0119
(GALE) To Present at American College of Surgeons Clinical Congress 2013
- NeuVax induces a full immune response in treated patients and creates an immune memory to target residual cancer cells
- Phase 3 PRESENT HER2 1+/2+ patients confirmed as optimal treatment population
PORTLAND, Ore., Oct. 7, 2013 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced an oral presentation given today at the American College of Surgeons Clinical Congress 2013 taking place October 6-10, 2013 in Washington D.C.
The oral presentation, entitled “Predicting Clinical Benefit After Completion of Treatment with the Adjuvant Breast Cancer Vaccine, NeuVax™ (nelipepimut-S or E75),” analyzed biomarker data and clinical outcomes from the NeuVax phase 2 trial. A number of variables were analyzed, including HER2 levels, effect of boosters, induction, and amplification of the NeuVax T-cell response. The data demonstrates that induction, rather than amplification, of an anti-HER2 immune response confers optimal clinical benefit and may partially explain why NeuVax works in HER2 IHC 1+/2+ patients with low-to-intermediate HER2 antigen exposure. This data is consistent with previously published biomarker data indicating a correlation between increasing NeuVax specific T-cells following vaccination and reductions in breast cancer recurrence rates.
“The presentation by Dr. Berry reinforces two key aspects of the NeuVax Phase 3 PRESENT trial. First, the data supports the correlation of the mechanism of action of NeuVax during the induction dosing. Second, immune T-cell response targeting HER2 expressing cancer cells correlates with reduction in recurrences in the target patient population, and that PRESENT is targeting the patient population with women who have a low-to-intermediate expression of HER2 with an unmet medical need,” said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma.
NeuVax is a cancer immunotherapy that harnesses the power of the immune system to seek out and destroy HER2 presenting cancer cells. NeuVax is the most immunogenic peptide of the HER2 protein which is injected into the body to allow the immune system to develop a robust HER2-directed T-cell response, creating immune memory, and priming the immune system against tumor cells. This active immunotherapy can not only kill tumor cells present at the time of therapy, but with the additional advantage of immune memory, the boosted immune system is primed to eradicate any remaining or recurrent tumor cells in a patient.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena’s product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations for our commercial success, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
CONTACT: Remy Bernarda Senior Director, Communications (503) 405-8258 rbernarda@galenabiopharma.com
(CXM) Provides Update On Exchange Listing
SAN DIEGO, Oct. 7, 2013 — Cardium Therapeutics (NYSE MKT: CXM) today provided an update on its exchange listing. As previously reported, a communication from the staff of the Company’s current listing exchange, NYSE MKT, indicated that the Company was considered to be noncompliant with certain listing requirements based on its quarterly report for the period ended September 30, 2012, and provided that the company should submit a plan to staff of the exchange that would reestablish compliance with the NYSE MKT listing requirement by March 31, 2013. On December 6, 2012, the company reported that it had submitted a plan designed to reestablish compliance with the exchange’s requirement in advance of the March 31, 2013 time frame, and on January 6, 2013, announced that the plan had been accepted by the listing exchange. On April 5, 2013, the Company reported that the NYSE MKT had granted an additional quarterly extension of the listing exchange compliance plan from March 31 to June 30, 2013. On July 2, 2013, the Company reported that its exchange had granted an additional quarterly extension of the listing exchange compliance plan from June 30, 2013 to September 30, 2013. The Company today reports that the NYSE MKT has granted an additional quarterly extension of the listing exchange compliance plan from September 30, 2013 to December 31, 2013.
The notification received from the listing exchange had no current effect on the listing of the company’s shares on the exchange. Rather the Company has now been afforded the opportunity to regain compliance with the requirements of Section 1003(a)(iv) of the exchange’s company guide by the end of the revised plan period of December 31, 2013, although as is normal course the Company’s exchange compliance would continue to be evaluated on an ongoing basis. Additional information and provisions regarding the NYSE MKT requirements are found in Part 10 of its company guide. The Company will be subject to periodic review by the exchange staff during the period covered by the plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the applicable extension periods could result in the Company’s shares being delisted from the exchange. If the Company’s common stock was not traded on the NYSE MKT, it would be expected to trade on the OTC exchange, an alternative regulated quotation service that provides quotes, sale prices and volume information in over-the-counter equity securities. The Company’s common stock was traded on the OTC until July 2007, when the company elected to instead list its shares on the NYSE MKT (formerly the American Stock Exchange).
About Cardium
Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium has four private company business units in its medical opportunities portfolio: (1) LifeAgain® Insurance Solutions, Inc. which is focused on building the Company’s medical data analytics platform technology and selling term life insurance. LifeAgain recently announced its first term life insurance program for men with prostate cancer; (2) Angionetic Therapeutics™, which includes Cardium’s late-stage DNA-based Generx® cardiovascular biologic product candidate; (3) Activation Therapeutics™, which includes the Company’s regenerative medicine wound healing technology platform, including its Excellagen® advanced wound care product; and (4) To Go Brands®, which includes the Company’s health sciences and nutraceutical business. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. For more information, visit www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there is no assurance that the Company will satisfy the requirements of its compliance plan and will otherwise continue to satisfy the listing requirements of its exchange or that its shares can continue to be listed on a national exchange; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that regulatory approvals can be obtained in a timely manner or at all; that partnering, distribution or other commercialization efforts can be achieved; that our products or proposed products will prove to be sufficiently safe and effective; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that third parties on whom we depend will behave as anticipated; or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of biologics, medical devices and other products, and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new products and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2013 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics®, Generx®, Excellagen®, LifeAgain®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics™, Activation Therapeutics™ are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands®, High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, Smoothie Complete®, Trim Green Coffee Bean™, and Trim Energy®, are trademarks of To Go Brands, Inc. Other trademarks belong to their respective owners.
(TKMR) Presents TKM-PLK1 Data at 6th Annual North American Neuroendocrine Tumor Society
New Data Shows Positive Chromogranin-A Biomarker Results in GI-NET Patient
Phase I/II Clinical Trial with TKM-PLK1 Ongoing in Patients with Advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC)
VANCOUVER, British Columbia, Oct. 4, 2013 — Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that it presented additional TKM-PLK1 data at the 6th Annual NET Conference hosted by the North American Neuroendocrine Tumor Society (NA-NETS) to be held in Charleston, South Carolina from October 4-5, 2013.
“We are pleased to present data at this conference reaching researchers and physicians treating patients who have been diagnosed with neuroendocrine tumors. We have an ongoing Phase I/II clinical trial with TKM-PLK1, with current enrollment targeting patients with either advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC), initiated following encouraging drug activity observed in these indications during Phase I,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
Tekmira has enrolled a total of 36 patients in a population of advanced cancer patients with solid tumors. Doses ranged from 0.15 mg/kg to 0.90 mg/kg during the dose escalation portion of the trial, with the maximum tolerated dose (MTD) of 0.75 mg/kg administered to the expansion cohort. A total of 174 doses were administered with a mean number of 5.3 doses per patient (range of 1-31 doses). No dose dependent changes in liver function tests were observed.
Forty percent (6 out of 15) of patients evaluable for response, treated at a dose equal to or greater than 0.6 mg/kg, showed clinical benefit. Of the 36 patients enrolled, three out of the four ACC patients (75%) treated with TKM-PLK1 achieved stable disease, including one patient who saw a 19.3% reduction in tumor size and is still on study receiving TKM-PLK1. Of the two GI-NET patients enrolled, both experienced clinical benefit: one patient had a partial response based on RECIST criteria, and the other GI-NET patient achieved stable disease and showed a greater than 50% reduction in Chromogranin-A (CgA) levels, a key biomarker used to predict clinical outcome and tumor response.
“Lowered levels of Chromogranin-A (CgA) are linked to improved survival and favorable response to treatment in neuroendocrine patients. We are encouraged that a GI-NET patient who achieved stable disease showed a greater than 50% decline in CgA levels. We intend to collect CgA data in our ongoing TKM-PLK1 Phase I/II clinical trial and expect to have results from this completed trial by mid-2014. If supported by the data, we will commence a pivotal trial in GI-NET in 2014,” added Dr. Murray.
About Chromogranin-A (CgA)
There have been recent advances in neuroendocrine biomarkers, including research that demonstrates elevated CgA levels correlate with disease burden and poor outcomes, providing evidence that baseline and serial CgA levels may be used to monitor clinical outcome.
About the TKM-PLK1 Phase I/II Clinical Trial
The ongoing TKM-PLK1 Phase I/II clinical trial, which is currently targeting GI-NET and ACC patients for enrollment, is a multi-center, single arm, open label study designed to measure efficacy using RECIST and tumor biomarkers for GI-NET patients, as well as to evaluate TKM-PLK1’s safety, tolerability and pharmacokinetics. TKM-PLK1, which employs a unique lipid nanoparticle (LNP) formulation for oncology applications, will be administered weekly with each four-week cycle consisting of three once-weekly doses followed by a rest week. It is expected that approximately 20 patients with advanced GI-NET or ACC tumors will be enrolled in this trial, with a minimum of 10 GI-NET patients to be enrolled.
About TKM-PLK1
Tekmira’s lead oncology product candidate, TKM-PLK1, targets polo-like kinase 1 (PLK1), a protein involved in tumor cell proliferation and a validated oncology target. Inhibition of PLK1 expression prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell. PLK1 has been a target of interest for years, and evidence that patients with elevated levels of PLK1 in their tumors exhibit poorer prognosis and survival rates has been documented in the medical literature. By using an RNAi approach and exploiting its naturally occurring mechanism of action, Tekmira can potentially overcome the limitations of other approaches and effectively silence PLK1.
About Gastrointestinal Neuroendocrine Tumors (GI-NET)
Neuroendocrine tumors (NETs) refers to a group of unusual and complex cancers that affect neuroendocrine cells, with those arising in the gastrointestinal tract referred to as GI-NET. It is estimated that there has been a four-fold increase in the incidence of NETs between 1973 and 2004. Approximately 55,000 people are living with GI-NET in the United States. There is a poor prognosis for advanced metastatic NETs, with 25% of patients surviving less than one year. The treatment of patients with gastrointestinal neuroendocrine tumors remains a challenge, and currently there are no approved anti-cancer drugs or treatments indicated specifically for GI-NET.
About Adrenocortical Carcinoma (ACC)
Adrenocortical Carcinoma (ACC) is a rare cancer that forms in the outer layer of tissue of the adrenal gland (a small organ on top of each kidney that makes steroid hormones, adrenaline, and noradrenaline to control heart rate, blood pressure, and other body functions). Even with appropriated diagnosis and treatment, most patients will develop recurrence and succumb to ACC because of the underlying tumor biology, the difficulty of achieving a complete resection, and the lack of effective systemic therapies.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements are generally identifiable by use of the words “believes,” “may,” “plans,” “will,” “anticipates,” “intends,” “budgets,” “could,” “estimates,” “expects,” “forecasts,” “projects” and similar expressions, and the negative of such expressions. Forward-looking statements in this news release include statements about Tekmira’s strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs; the results of the Phase I clinical trial with TKM-PLK1; the effects of Tekmira’s products on the treatment of cancer, including gastrointestinal neuroendocrine tumors (GI-NET) and adrenocortical carcinoma (ACC); the expected completion and release of data from a Phase I/II clinical trial with TKM-PLK1, which will enroll patients with advanced GI-NET or ACC tumors; and, the expected timing of the commencement of a pivotal trial in GI-NET in 2014.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP’s status as a leading RNAi delivery technology; the effectiveness of Tekmira’s products as a treatment for cancer, including gastrointestinal neuroendocrine tumors (GI-NET) and adrenocortical carcinoma (ACC); results in preclinical models are indicative of the potential effect in humans; Tekmira’s research and development capabilities and resources; FDA approval with respect to commencing clinical trials; the timing and obtaining of regulatory approvals for Tekmira’s products; the time required to complete research and product development activities; and Tekmira’s ability to protect its intellectual property rights and not to infringe on the intellectual property rights of others. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the completion of, and timing of the release of the data from, the Phase I/II clinical trial with TKM-PLK1 may not occur as anticipated, or at all; TKM-PLK1 may not enter a pivotal trial in GI-NET within the timeframe anticipated, or at all; Tekmira’s ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmira’s research and development capabilities and resources will not meet current or expected demand; Tekmira’s products may not prove to be effective in the treatment of cancer, including GI-NET or ACC; the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; the FDA will not approve the commencement of Tekmira’s planned clinical trials or approve the use of Tekmira’s products and generally, difficulties or delays in the progress, timing and results of clinical trials; the FDA may determine that the design and planned analysis of Tekmira’s clinical trials do not adequately address the trial objectives in support of Tekmira’s regulatory submissions; pre-clinical and clinical trials may be more costly or take longer to complete than anticipated; pre-clinical or clinical trials may not generate results that warrant future development of the tested drug candidate; and the possibility that Tekmira has not sufficiently budgeted for expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s annual report on Form 20-F for the year ended December 31, 2012 (Annual Report), which is available at www.sedar.com or at www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
CONTACT: Investors Jodi Regts Director, Investor Relations Phone: 604-419-3234 Email: jregts@tekmirapharm.com Media David Ryan Longview Communications Inc. Phone: 416-669-7906 Email: dryan@longviewcomms.ca
(TXMD) to Present at 12th Annual Bio Investor Forum
TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that the Company will present at the 12th Annual BIO Investor Forum. Hosted by the Biotechnology Industry Organization (BIO), the 12th Annual BIO Investor Forum features leading private and emerging public companies. The meeting will take place October 8-9, 2013 at the Palace Hotel in San Francisco, CA.
Robert Finizio, Co-Founder and Chief Executive Officer, will present on Wednesday, October 9, 2013 at 8:30 a.m. Pacific Time.
The presentation will also be available via a live audio webcast at the following link: http://www.veracast.com/webcasts/bio/investorforum2013/21201212401.cfm
Following the presentation, a replay will be available on TherapeuticsMD’s website at www.therapeuticsmd.com under the “Investor Relations” section and will remain available for 30 days after the actual presentation date.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.
vitaMedMD® and TherapeuticsMD® are registered trademarks of TherapeuticsMD, Inc. BocaGreenMD™ is a trademark of TherapeuticsMD, Inc.
About the BIO Investor Forum
The 12th Annual BIO Investor Forum is an international investor conference focused on private and emerging public biotech companies. Because its mission is to support industry-wide success, it presents a broad and unbiased view of investment opportunities. In addition, the BIO Investor Forum draws business development executives from leading global pharmaceutical and established biotechnology companies.
(LOJN) Law Enforcement Liaison Peter Perrien Next President of IAATI
CANTON, Mass., Oct. 4, 2013 — LoJack Corporation (NASDAQ: LOJN), a provider of vehicle theft recovery systems and advanced fleet management solutions, announced today that Peter Perrien was named the 62nd president of the International Association of Auto Theft Investigators (IAATI). Perrien’s election was announced at the Annual IAATI Training Seminar, which was held in Rimini, Italy.
The IAATI is an organization of nearly 4,000 members from around the world – all volunteers – who are focused on combining resources and training to improve communication and coordination between professional auto theft investigators across the globe. Perrien will head the group that includes experienced professionals from across the automotive industry including law enforcement agencies, insurance representatives, manufacturers and rental car companies as well as members of the National Insurance Crime Bureau.
“We are thrilled that Peter has been named IAATI’s next president,” said Patrick Clancy, Vice President of LoJack’s Law Enforcement Department. “Peter’s extensive career in law enforcement, specifically leading auto theft investigations, embodies everything that IAATI stands for. He is a tremendous selection to lead the organization for the foreseeable future.”
“We see millions of dollars in assets lost each year due to vehicle theft and the only way to combat it is through education, training and collaboration,” said Perrien. “My goal, and the goal for IAATI, is to keep training and educating to let the police know who we are and what we are about.” As president of IAATI, Perrien will focus on the organization’s primary message, which is to provide a global approach to vehicle theft deterrence, investigation, recovery and its kindred crimes. To do so, Perrien will be looking to expand training, networking and the recruitment of new members. He will also be looking to implement more localized trainings and seminars that target the education of law enforcement on critical topics including identification and insurance fraud, salvage thefts and emerging trends in the automotive theft market.
Perrien began his career with the New Orleans Police Department (NOPD) as a patrol officer in 1972. In the ensuing years, Perrien served as an intelligence detective for the white collar/organized crime unit and also as a technology detective for the FBI and NOPD Public Integrity Special Operations unit. In 2000, Perrien accepted a Law Enforcement Liaison position with LoJack and has served the Louisiana region for 13 years. Perrien has been a member of the IAATI board since 2006 and will continue to serve as a LoJack Law Enforcement Liaison in Louisiana.
“Peter is a dedicated member of IAATI and as such, a perfect choice for the next president,” said John O’Byrne, IAATI’s 61st president. “Peter and I have known each other for years and his track record in law enforcement and auto theft speaks for itself. I have no doubt that he will continue to serve the organization in an outstanding capacity, just as he has done in the past serving as vice president.”
For more information about LoJack’s team of Law Enforcement Liaisons, please visit http://www.lojack.com/For-Law-Enforcement.
About IAATI
The International Association of Auto Theft Investigators (IAATI) was formed in 1952 in order to improve communication and coordination among the growing family of professional auto theft investigators. It has grown to 3,604 members representing over 35 countries and includes representatives of law enforcement agencies, as well as many others with a legitimate interest in auto theft investigation, prevention and education. We recognize that, just as law enforcement agencies cannot successfully function independent of one another, auto theft investigation requires the active participation of the private sector; therefore, our membership also includes the insurance industry, automobile manufacturers, car rental companies and, of course, the National Insurance Crime Bureau and its sister agencies in Canada and Europe.
About LoJack Corporation
LoJack Corporation, the company that has helped more than nine million people protect their vehicles in the event of theft over the past 25+ years, today provides safety, security and protection for an ever-growing range of valuable assets and people. Leveraging its core strengths, including its well-known brand, direct integration with law enforcement and dealer distribution network, LoJack Corporation is expanding into new areas across the continuum from theft deterrence to recovery. The Company is focusing on creating a new level of value for its dealer, customer and investor communities by delivering innovative offerings and multiple technologies in expanding geographies. For more information, visit www.lojack.com, www.autotheftblog.com, www.youtube.com/lojack, www.twitter.com/LoJackCorp or www.Facebook.com/LoJackCorp.
© 2013 LoJack Corporation. All rights reserved. LoJack and the LoJack logo are trademarks or registered trademarks of LoJack Corporation in the United States and other countries.
CONTACT: | ||
Jeremy Warnick | Matt Landry | Maria Brown |
LoJack Corp. | Matter Communications | Matter Communications |
781-302-4251 | 978-499-9250, x 226 | 978-499-9250, x212 |
jwarnick@lojack.com | lojack@matternow.com | lojack@matternow.com |
(DSCO) Announces FDA Approval of SURFAXIN®
Commercial Introduction of SURFAXIN Planned for the Fourth Quarter of 2013
WARRINGTON, Pa., Oct. 4, 2013 — Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the U.S. Food and Drug Administration (FDA) has agreed to the Company’s updated product specifications for SURFAXIN® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The Company has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.
“We are pleased that the FDA has agreed with our updated product specifications and are appreciative of the process that has lead to this decision,” said John G. Cooper, Chief Executive Officer of Discovery Labs. “SURFAXIN represents the first milestone in our goal of transforming the treatment of RDS and is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants for the prevention of RDS.”
ABOUT SURFAXIN
The U.S. Food and Drug Administration (FDA) approved SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant’s clinical condition assessed and stabilized.
SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care. Discovery Labs’ novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies. Discovery Labs’ strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants. Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, significantly expand the current worldwide RDS market.
For more information, please visit the Company’s website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to Discovery Labs’ plans to manufacture commercial lots of SURFAXIN and the timing of the commercial launch and market acceptance of SURFAXIN, are described in Discovery Labs’ filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.
(GALE) to Present at the 12th Annual BIO Investor Forum
PORTLAND, Ore., Oct. 4, 2013 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark W. Schwartz, Ph.D., Executive Vice President and Chief Operating Officer will present a corporate update at the 12th Annual BIO Investor Forum. The presentation will take place on Wednesday, October 9, 2013 at 9:00 a.m. PT at The Palace Hotel in San Francisco, CA.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit www.galenabiopharma.com.
CONTACT: Remy Bernarda Senior Director, Communications (503) 405-8258 rbernarda@galenabiopharma.com
(OMER) Unlocks Six Additional Class A Orphan GPCRs and Identifies Small Molecules
Brings Omeros’ Total to 52 Class A Orphans and Opens Way to New Oral Drugs to Treat Diabetes and Osteoporosis
SEATTLE, Oct. 3, 2013 — Omeros Corporation (NASDAQ: OMER) today announced that it has identified compounds that functionally interact with each of six additional orphan G protein-coupled receptors (GPCRs) that have been linked to a wide range of diseases in the areas of neurologic disorders, cardiovascular disease and oncology. Identification of compounds that functionally interact with orphan GPCRs facilitates the development of drugs that target those receptors. Omeros has now unlocked 52 Class A orphan GPCRs, representing approximately 65 percent of these targets.
The six additional orphan GPCRs unlocked by Omeros are GPR37, GPR37L1, GPR132, GPR174, GPR176 and LGR5. GPR37 has been linked to Parkinson’s disease. GPR37L1, GPR132 and GPR176 are associated with cardiovascular indications, specifically hypertension and cardiac hypertrophy (GPR37L1 and GPR132) and atherosclerosis (GPR176). GPR174 has been linked to melanoma and Grave’s disease, while LGR5 is expressed in cancer stem cells and has been associated with esophageal adenocarcinoma.
In addition, using its proprietary Cellular Redistribution Assay (CRA) technology, which has already successfully “unlocked” 52 Class A orphan GPCRs, Omeros has identified small molecules that interact with two non-orphan Class B GPCRs; the glucagon-like peptide 1 receptor (GLP-1R) and the parathyroid hormone 1 receptor (PTH-1R). Both of these receptors are established drug targets—GLP-1R for diabetes and PTH-1R for osteoporosis. The marketed drugs currently available that target these receptors are all injectable, with 2012 annual sales of GLP-1R agents and PTH-1R agents exceeding $2.0 billion and $1.1 billion, respectively. Omeros’ identification of small molecules targeting GLP-1R and PTH-1R could lead to the development of oral medications for these diseases that provide dosing advantages over the injectable agents on the market. Omeros is in the process of filing broad patent applications around its discoveries, and compound optimization efforts are in progress.
“Using our proprietary technology, we continue to add to the number of druggable Class A orphan GPCRs – now 52 and spanning a broad range of important disorders – that we believe Omeros exclusively controls,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Our team has now also turned to Class B GPCRs, starting with two receptors that are commercially validated but whose corresponding marketed drugs are only peptides or proteins, requiring daily or weekly injections. By identifying small molecules that functionally interact with these receptors, Omeros is opening the door to new oral treatments for diabetes and bone loss.”
Ongoing GPCR Program
Omeros is screening orphan GPCRs against its small-molecule chemical libraries using its proprietary, high-throughput CRA technology. The CRA detects receptor antagonists, agonists and inverse agonists. Omeros has announced that it has identified and confirmed sets of compounds that interact selectively with 52 orphan receptors linked to metastatic melanoma and lung cancer (GPR19), renal cell carcinoma, ovarian cancer and inflammatory conditions (GPR65/TDAG8), ovarian cancer, prostate cancer, bone diseases and asthma (GPR68/OGR1), hepatocellular carcinoma (GPR80), squamous cell carcinomas, bladder carcinoma, hepatocellular carcinoma and lung cancer (GPR87), ovarian cancer (GPR150), metastatic epithelial cancers, congenital cataracts and birth defects of the brain and spinal cord (GPR161), melanoma and Grave’s disease (GPR174), cancer stem cells and self-renewal and maintenance of adult stem cells (LGR4, LGR5), esophageal adenocarcinoma (LGR5), leukemia (P2Y8/P2RY8), arterial stiffness (GPR25), hypertension and cardiac hypertrophy (GPR37L1), atherosclerosis (GPR132 and GPR176), multiple sclerosis, spinal cord injury, traumatic brain injury (GPR17),anxiety disorders (GPR31), Parkinson’s disease (GPR37), schizophrenia (GPR52, GPR153), autism (GPR63), bipolar disorder (GPR78), anxiety, post-traumatic stress disorder, body weight abnormalities and autoimmune diseases (GPR83), motor control (GPR139), schizophrenia, cognitive impairments and mood disorders (GPR151), cognitive impairments, blood pressure abnormalities and colon cancer (MAS1), pain (MRGE), circadian rhythm irregularities and sleep disorders (OPN4), obesity, cognitive impairments and motor disorders (GPR12), obesity and diabetes (GPR21), obesity-related type-2 diabetes (GPR39), obesity, metabolic disorders, thermoregulation, mood disorder and bipolar disorder (GPR50), appetite control (GPR82, GPR101), metabolic and psychotic disorders (SREB1/GPR27, SREB2/GPR85, SREB3/GPR173), rheumatoid arthritis (CCRL2), rheumatoid arthritis and HIV-mediated enteropathy (GPR15), osteoarthritis (GPR22), acute inflammatory responses (GPR32), humoral immunity (GPR183), regulation of hematopoietic stem cell differentiation (GPR171), long-term wound repair, including the formation of new hair follicles (LGR6). In addition, Omeros has unlocked GPR20, GPR45, GPR135, GPR141, GPR162, GPR182, MRGF and OPN5, which are expressed preferentially in the gastrointestinal tract (GPR20), brain (GPR45, GPR135, GPR162 and OPN5), dorsal root ganglia (MRGF), bone marrow, spleen, skin and lung (GPR141) and throughout the body (GPR182).
About G Protein-Coupled Receptors
GPCRs, which mediate key physiological processes in the body, are one of the most valuable families of drug targets. According to Insight Pharma Reports, GPCR-targeting drugs represent 30 to 40 percent of marketed pharmaceuticals. Examples include Claritin® (allergy), Zantac® (ulcers and reflux), OxyContin® (pain), Lopressor® (high blood pressure), Imitrex® (migraine headache), Reglan® (nausea) and Abilify® (schizophrenia, bipolar disease and depression) as well as all other antihistamines, opioids, alpha and beta blockers, and compounds acting through serotonin and dopamine receptors.
The industry focuses its GPCR drug discovery efforts mostly on non-sensory GPCRs. Of the 363 total non-sensory GPCRs, approximately 240 have known ligands (molecules that bind the receptors) with nearly half of those targeted either by marketed drugs (46 GPCRs) or by drugs in development (about 82 GPCRs). There are approximately 120 GPCRs with no known ligands, which are termed “orphan GPCRs.” Without a known ligand, drug development for a given receptor is extremely difficult.
Omeros uses its proprietary high-throughput CRA to identify small-molecule agonists and antagonists for orphan GPCRs, unlocking them to drug development. Omeros believes that it is the first to possess the capability to unlock orphan GPCRs in high-throughput, and that currently there is no other comparable technology. Unlocking these receptors could lead to the development of drugs that act at these new targets. There is a broad range of indications linked to orphan GPCRs including cardiovascular disease, asthma, diabetes, pain, obesity, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, schizophrenia, learning and cognitive disorders, autism, osteoporosis, osteoarthritis and several forms of cancer.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company’s lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros’ five other clinical programs are focused on schizophrenia, Huntington’s disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. These statements include, but are not limited to, statements regarding the number of orphan GPCRs that Omeros expects to unlock; the potential development of new drugs, including oral medications that provide dosing advantages over injectable agents on the market; the potential indications of the orphan GPCRs unlocked by Omeros; Omeros’ potential patent rights for each unlocked orphan GPCR; its exclusive control over Class A orphan GPCRs; Omeros’ expectations regarding its ability to unlock GPCRs; and the planned commercial launch of OMS302 in 2014. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2013. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
(ASTI) Announces Availability of EnerPlex™ Products on Walmart.com
Ascent Solar Technologies, Inc. (NASDAQ:ASTI), a manufacturer of consumer and off-grid products integrated with flexible thin-film photovoltaic modules (CIGS), announced today the availability of its EnerPlex™ product line via Walmart.com.
Victor Lee, President & CEO of Ascent Solar, said, “The ability for our customers to purchase EnerPlex products from the world’s largest retailer Wal-Mart is a huge advantage for the growth of the EnerPlex brand. The growth of ecommerce as the preferred method of shopping by most American consumers is a trend which EnerPlex is perfectly positioned to take advantage of.”
The full listing of EnerPlex products on Walmart.com can be found here: http://tinyurl.com/ltuo9of
The EnerPlex Product line has quickly changed the paradigm of solar-integrated consumer electronics, providing consumers with lightweight, powerful and extremely durable charging solutions for all their portable electronics. Surfr™, a line of solar and battery integrated phone cases, allows users to charge their phone anywhere and in cases of emergency. Kickr™, a line of portable solar chargers, provides a charging solution for most USB enabled devices providing power almost anywhere and in nearly every situation and is perfect for emergency preparedness. With the addition of the Jumpr™ line of portable batteries, consumers now have a complete, integrated, solar charging and storage solution for life on the go.
About Ascent Solar Technologies:
Ascent Solar Technologies, Inc. is a developer of thin-film photovoltaic modules with substrate materials that are more flexible, versatile and rugged than traditional solar panels. Ascent Solar modules can be directly integrated into consumer products and off-grid applications, as well as aerospace and building integrated applications. Ascent Solar is headquartered in Thornton, Colorado. For more information, go to www.ascentsolar.com.
Forward-Looking Statements:
Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other unknown factors that could cause the Company’s actual operating results to be materially different from any historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements that explicitly describe these risks and uncertainties, readers are urged to consider statements that contain terms such as “believes,” “belief,” “expects,” “expect,” “intends,” “intend,” “anticipate,” “anticipates,” “plans,” “plan,” to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission.
(OINK) Inks Sales Agreements with Eight Hotels and Restaurants in Wuhan City
WUHAN CITY, China, Oct. 3, 2013 — Tianli Agritech, Inc. (NASDAQ:OINK) (“Tianli” or the “Company”), a leading producer of breeder hogs, market hogs and black hogs, headquartered in Wuhan City, China, today announced that its operating subsidiary, Hubei Tianzhili Breeder Hog Co. Ltd. (“Tianzhili”), had signed one-year sales contracts with eight hotels and restaurants in Wuhan City, Hubei Province. Among the eight new customers for the Company’s Tianli-Xiduhei™ black hog meat cuts are three hotels – WuLingNianDai, DongXin, and Citizen and five restaurants – NongJiaXiaoYuan, ChuYuWang, ShuiMoRenJia, CuiZhuYuan, and XiaXingTianXia.
“We are delighted to serve these leading hotels and restaurants with our premium quality black hog meat cuts. Our association with these well-known hotels and restaurants should enhance the reputation of our branded black hog meat. As our distribution network continues to expand at a fast clip, we are increasingly excited about the growth prospects of our black hog program and our retail business. This, combined with the recovery of pork prices in recent months, sets the stage for continuing top-line growth and Tianli’s return to profitability in coming quarters,” said Mrs. Hanying Li, Chairwoman and Chief Executive Officer of Tianli.
About Tianli Agritech, Inc.
Tianli Agritech, Inc. is in the business of breeding, raising and selling breeder and market hogs in China and is developing a retail channel for its pork products including high-value, black hog meat. The Company is focused on growing high quality hogs for sale for breeding and meat purposes. The Company conducts genetic, breeding and nutrition research to steadily improve its production capabilities.
Forward-Looking Statements
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by this cautionary statement and any other cautionary statements which may accompany the forward-looking statements. In addition, the company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
For more information, please contact:
Tina Xiao
Weitian Group LLC
Phone: +1-917-609-0333
Email: tina.xiao@weitian-ir.com
Web: http://www.weitian-ir.com
(GALE) Launches Abstral(R) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain
First Commercial Product for Galena Biopharma Available Nationwide
PORTLAND, Ore., Oct. 3, 2013 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the official product launch of Abstral® (fentanyl) Sublingual Tablets in the United States. Abstral is a sublingual (under the tongue) fentanyl tablet indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Galena acquired Abstral in March 2013 and since that time has scaled its field commercial team, manufactured the drug for commercial sale, secured broad access and reimbursement support from commercial and federal health insurance entities, implemented a robust patient assistance program, and developed a broad product distribution network. Abstral can be prescribed by healthcare professionals and is available to patients at all retail pharmacies nationwide.
“As an oncology company dedicated to improving patients’ lives, we are thrilled to introduce Abstral as our first commercial product and offer cancer patients relief from their breakthrough pain,” said Mark J. Ahn, President and Chief Executive Officer. “We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no speacial handling or disposal. We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena. I look forward to reporting our continued progress later this year.”
Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. Breakthrough cancer pain occurs in the majority of patients who are already receiving chronic, long-acting opioid pain management and yet have episodes of severe tumor- and treatment-related cancer pain. Breakthrough pain occurs frequently in these patients, particularly as they try to conduct normal daily activities, with a mean number of episodes of 4 per day (range of 1-14 per day) and a median duration of 30 minutes (range of 1-240 minutes). The wide range of time to relief of these severe pain episodes leads to high levels of distress and impaired quality of life experienced by patients.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impact 40%-80% of cancer patients. Abstral is approved by the U.S. Food and Drug Administration, and is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.
Important Abstral Safety Information
- There is a risk of respiratory depression, medication errors, and abuse potential with the use of Abstral. See full prescribing information for important complete black-box warning.
- Due to the risk of fatal respiratory depression, ABSTRAL is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
- Keep out of reach of children.
- Use with CYP3A4 inhibitors may cause fatal respiratory depression.
- When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL.
- When dispensing, do not substitute with any other fentanyl products.
- Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
- ABSTRAL is available only through a restricted program called the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena’s product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations for our commercial success, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
CONTACT: Remy Bernarda Senior Director, Communications (503) 405-8258 rbernarda@galenabiopharma.com
(ICH) Signs Letter of Intent to Acquire Investors Capital Holdings
NEW YORK, and LYNNFIELD, Mass., Oct. 2, 2013 — RCS Capital Corporation (“RCAP”) (NYSE: RCAP) and Investors Capital Holdings, Ltd. (“ICH”) (NYSE MKT: ICH) announced today that they have entered into a letter of intent relating to the acquisition by RCAP of ICH. Following this transaction, ICH and its subsidiaries will become RCAP’s sixth line of business (after the recently announced acquisition of the Hatteras Funds Group) and, through the leadership of Tim Murphy, President and Chief Executive Officer of ICH, and his management team, will continue to operate autonomously under ICH’s respective brands as part of the RCAP family of companies.
Incorporated in 1995, ICH is a financial services holding company that operates primarily through its wholly-owned broker-dealer and registered investment advisor subsidiary, Investors Capital Corporation. ICH provides independent broker-dealer services and investment advisory services.
With its approximately 550 registered representatives across the United States, ICH is expected to complement and diversify RCAP’s revenue stream from its other lines of business: an existing wholesale broker-dealer, investment banking and capital markets services, transaction management and transfer agency businesses. Upon the closing of the ICH acquisition, RCAP expects that it will have deployed the remaining proceeds from its June 2013 initial public offering.
The closing of the transaction will be subject to certain to-be-agreed-upon conditions including SEC and FINRA approval of the proposed change in control and approval of the transaction by the stockholders of ICH. Any definitive agreement will contain customary representations, warranties and closing conditions. There can be no assurance, however, that RCAP and ICH will be successful in negotiating a definitive agreement or whether the terms of such definitive agreement will differ substantially from those described herein.
Subject to the satisfaction of these conditions, the transaction is expected to close in the first quarter of 2014.
About RCAP
RCAP is a publicly traded Delaware holding company listed on the New York Stock Exchange formed to operate and grow businesses focused on the retail direct investment industry. RCAP holds a direct minority economic interest in Realty Capital Securities, LLC, a FINRA-registered wholesale broker-dealer and an investment banking and capital markets business, American National Stock Transfer, LLC, an SEC-registered transfer agent, and RCS Advisory Services, LLC, a transaction management services business. Additional information about RCAP can be found on its website at www.rcscapital.com. RCAP may disseminate information about itself, including the results of its operations and financial information, via social media platforms such as Facebook, LinkedIn and Twitter.
About ICH
Investors Capital Holdings, Ltd. of Lynnfield, Massachusetts is a diversified financial services holding company that operates primarily through Investors Capital Corporation. Our mission is to provide premier, 5-star service and support to our valued registered representatives, including advisory programs, strategic practice management and marketing services, and technology, to help them grow their businesses and exceed their clients’ expectations. Business units include Investors Capital Corporation, ICC Insurance Agency, Inc., and Investors Capital Holdings Securities Corporation. For more information, please call (800) 949-1422 x4814 or visit www.investorscapital.com.
Forward-Looking Statements
Information set forth herein (including information included or incorporated by reference herein) contains “forward-looking statements” (as defined in Section 21E of the Securities Exchange Act of 1934, as amended), which reflect RCAP’s expectations regarding future events. The forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements.
Such forward-looking statements include, but are not limited to, the inability to negotiate or agree on definitive documentation; the ability to obtain requisite approvals for the acquisition, including, among other things, regulatory approval of certain changes in control of the ICH’s FINRA-regulated broker-dealer business; market volatility; unexpected costs or unexpected liabilities that may arise from the potential acquisition, whether or not consummated; the inability to retain key personnel; the deterioration of market conditions; and future regulatory or legislative actions that could adversely affect the parties to the transaction. Additional factors that may affect future results are contained in RCAP’s filings with the SEC, which are available at the SEC’s website at www.sec.gov. Further, forward-looking statements speak only as of the date they are made, and RCAP undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time, unless required by law.
Additional Information
Nothing in this release shall constitute a solicitation to buy or an offer to sell any securities. Any offer and sale of securities will only be made pursuant to an effective registration statement. RCAP stockholders and other investors are urged to read the registration statement, including the proxy statement/prospectus to be contained therein, to be filed with the SEC, because it will contain important information about the transactions. A copy of the registration statement and the proxy statement/prospectus, once filed, will be available free of charge at the SEC’s website (www.sec.gov). Copies of the proxy statement/prospectus and the filings with the SEC that will be incorporated by reference in the proxy statement/prospectus also will be obtainable, without charge, by directing a request to RCS Capital Corporation, 405 Park Ave., 15th Floor, New York, New York, Attention: Investor Relations, Telephone: (866) 904-2988.
Participants in Solicitation
The directors and executive officers of RCAP and other persons may be deemed to be participants in the solicitation of proxies in respect of proposals to approve the transaction. Information regarding RCAP’s directors and executive officers and other participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be available in the proxy materials to be filed with the SEC.
(FONR) Announces Fiscal 2013 Year End Results
MELVILLE, NY–(Oct 2, 2013) – FONAR Corporation (NASDAQ: FONR)
- Fiscal 2013 net revenues increase 25% over 2012 to $49.1 million
- Fiscal 2013 net income increases 49% over 2012 to $10.3 million
- Diluted Net Income Available to Common Shares for the Fiscal year ending June 30, 2013 was $1.34, which includes a partial reversal of the deferred tax valuation allowance of $2.5 million, or $0.41
- FONAR records fourteenth straight quarter of positive net income and income from operations
- FONAR added- to the Russell Microcap Index
FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported its fiscal 2013 results for the year ended June 30, 2013. The Company’s two industry segments are: development, manufacturing and servicing of the UPRIGHT® Multi-Position™ MRI, and management of Stand-Up® MRI (UPRIGHT® MRI) centers. The Company is known as the first Company to invent and manufacture an MRI (Magnetic Resonance) scanner. Leading the list of FONAR’s most recent patented inventions is its technology enabling full weight-bearing MRI imaging for the first time on all the gravity sensitive regions of the human anatomy, e.g. the spine, brain, hip, knee, ankle, foot, shoulder, and pelvis. The FONAR UPRIGHT® Multi-Position™ MRI scanner is the world’s only MRI scanner licensed under FONAR’s multiple UPRIGHT® MRI patents to scan all the patient’s body parts in their normal fully weight-bearing UPRIGHT® position.
FONAR (NASDAQ: FONR), Melville, NY, The Inventor of MR Scanning™, was incorporated in 1978, and is the first, oldest and most experienced MRI company in the industry. FONAR introduced the world’s first commercial MRI in 1980, and went public in 1981. Since its inception, nearly 300 recumbent-OPEN MRIs and 157 UPRIGHT® Multi-Position™ MRI scanners have been installed worldwide. FONAR’s stellar product is the UPRIGHT® MRI (also known as the Stand-Up® MRI), the only whole-body MRI that performs Position™ imaging (pMRI™) and scans patients in numerous weight-bearing positions, i.e. standing, sitting, in flexion and extension, as well as the conventional lie-down position. The FONAR UPRIGHT® MRI often sees the patient’s problem that other scanners cannot because they are lie-down and non “weight-bearing” only. The patient-friendly UPRIGHT® MRI has a near-zero claustrophobic rejection rate by patients. As a FONAR customer states, “If the patient is claustrophobic in this scanner, they’ll be claustrophobic in my parking lot.” Approximately 85% of patients are scanned sitting while they watch a 42″ flat screen TV. FONAR is headquartered on Long Island, New York.
###
UPRIGHT® and STAND-UP® are registered trademarks and The Inventor of MR Scanning™, Full Range of Motion™, Multi-Position™, Upright Radiology™, The Proof is in the Picture™, True Flow™, pMRI™, Spondylography™, Dynamic™, Spondylometry™, CSP™, and Landscape™, are trademarks of FONAR Corporation.
This release may include forward-looking statements from the company that may or may not materialize. Additional information on factors that could potentially affect the company’s financial results may be found in the company’s filings with the Securities and Exchange Commission.
Contact:
Daniel Culver
Director of Communications
E-mail: Email Contact
www.fonar.com
(CRRS) to Expand Professional Services
Corporate Resource Services, Inc. (NASDAQ:CRRS), a diversified technology, staffing, recruiting and consulting services firm, today announced that it is expanding the Professional Services segment of its business.
“Over the past eighteen months, we have been building our accounting and finance staffing and recruiting services practice, spearheaded from our Irvine, California and New York City offices,” said John Messina, Chief Executive Officer of Corporate Resource Services. “Our initial investment has paid off as this business has rapidly achieved gross margins much higher than our traditional business and operating margins that are impressive for a start-up. We have been fortunate to establish high-end relationships with many prominent financial institutions and professional services firms throughout the United States.”
“This is a business unit that we established in 2012, knowing that we had the opportunity to realize higher gross margins on bill rates in excess of $100 per hour,” said Mark S. Levine, Chief Operating Officer of CRS. “We have executed on our plan and built a team of consulting professionals that have past experience with major CPA Firms and large business consulting firms like Cap Gemini and Jefferson Wells. In addition, we have partnered with a large national CPA firm to provide contract staff for their project based solutions. We expect that this relationship alone will generate several million dollars in consulting business with 35%+ gross margins. This is just the tip of the iceberg for CRS in this high-end niche and we are investing in additional resources for our accounting and finance staffing team. We understand this business and are eager to capitalize on the opportunity for diversification of our portfolio of services, increasing our profitability and creating greater shareholder value.”
About Corporate Resource Services, Inc.:
Corporate Resource Services, Inc. provides cloud-based enterprise applications and hosting services to PEO and staffing companies, as well as diversified staffing, recruiting, and consulting services. The Company offers trained employees in the areas of Insurance, Information Technology, Accounting, Legal, Engineering, Science, Healthcare, Life Sciences, Creative Services, Hospitality, Retail, General Business and Light Industrial work. The company’s blended staffing solutions are tailored to our customers’ needs and can include customized employee pre-training and testing, on-site facilities management, vendor management, risk assessment and management, market analyses and productivity/occupational engineering studies.
The Company’s ability to deliver broad-based solutions provides its customers a “one stop shop” to fulfill their staffing needs from professional services and consulting to clerical and light industrial positions. Depending on the size and complexity of an assignment, Corporate Resource Services can create an on-site facility for recruiting, training and administration at the customers’ location. Company recruiters have the latest state of the art recruiting resources available to help customers secure the best candidates in today’s ever-changing marketplace. CRS’s national network of recruiters has staffing experts that get excellent results by focusing within their areas of expertise.
The Company operates 231 staffing and on-site facilities in 42 states and the District of Columbia and it offers its services to a wide variety of clients in many industries, ranging from sole proprietorships to Fortune 1000 companies. To learn more, visit http://www.crsco.com.
This press release contains forward-looking statements, which are subject to risks and uncertainties. Such statements are based on assumptions and expectations which may not be realized and are inherently subject to risks and uncertainties, many of which cannot be predicted with accuracy and some of which might not even be anticipated. Future events and actual results, financial and otherwise, may differ from the results discussed in the forward-looking statements. A number of these risks and other factors that might cause differences, some of which could be material, along with additional discussion of forward-looking statements, are set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.
(JMSN) Announces Appointment of Corporate Development Executive
LAS VEGAS, NV–(Oct 2, 2013) – Jameson Stanford Resources Corp. (OTCQB: JMSN) (the “Company”), an emerging metals and minerals exploration and development company, announced that it has appointed Michael Christiansen as Executive Vice President, Corporate Development. His responsibilities include capital markets, investor relations and corporate administration. Christiansen previously served as Executive Vice President and Chief Financial Officer with the Company and Bolcàn Mining Corporation prior to the October 2012 merger. Prior to joining the Company, Christiansen was Managing Director at WestPark Capital where he served in the corporate finance group from 2007 to 2012.
Christiansen has more than 15 years of investment banking experience, having served previously with Prudential Securities from 1997 to 2001, and with Seidler Amdec Securities and Laffer Associates from 1986 to 1992. Christiansen also served as executive vice president and chief financial officer of Vizional Technologies, Inc. from 2002 through 2006, and as executive vice president and chief financial officer of PortaCom Wireless, Inc. from 1994 to 1996.
Michael Stanford, CEO of Jameson Stanford, commented, “We are pleased that Michael Christiansen has re-joined our management team, and we look forward to his leadership in securing additional capital necessary to expand the Company’s minerals exploration and discovery program.”
About Jameson Stanford Resources Corp.
Jameson Stanford Resources is focused on developing significant mining claims, mineral leases and excavation rights for projects located in historic mining districts and other sites in central and southwestern Utah. The Company is presently engaged in mineral exploration activities in connection with copper, gold, silver and base metals properties located in historic mining districts in Beaver County and Juab County, Utah. In addition, Jameson Stanford Resources has acquired excavation rights and special permitting related to deposits of alluvial minerals and silica sand located in Weber County, Utah.
Safe Harbor Forward-Looking Statements
In connection with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Jameson Stanford Resources Corporation, is hereby providing cautionary statements identifying important factors that could cause our actual results to differ materially from those projected in forward-looking statements (as defined in such act). Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “intends,” “plans,” “believes” and “projects”) may be forward-looking and may involve estimates and uncertainties which could cause actual results to differ materially from those expressed in the forward-looking statements. These statements include, but are not limited to, our expectations concerning the presence of minerals and our ability to mine and process minerals commercially at a profit.
We caution that the factors described herein could cause actual results to differ materially from those expressed in any forward-looking statements we make and that investors should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors emerge from time to time, and it is not possible for us to predict all of such factors. Further, we cannot assess the impact of each such factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Contact:
Jameson Stanford Resources Corp.
Las Vegas, NV
www.JamesonStanford.com
702-933-0808
IR@JamesonStanford.com
Mission Investor Relations
Atlanta, GA
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(CLPI) Indian Subsidiary Direct Bill Payment Integration with Indian Utilities Hits 25M Consumers
Calpian, Inc. (OTC: CLPI) CEO Harold Montgomery and Money on Mobile CEO Shashank M Joshi announced today that the Company’s subsidiary, mobile payment subsidiary, Money on Mobile, has completed formal direct bill payment integration arrangements with five Indian utility providers covering a total customer base of over 25 million consumers nationwide. These new integrations allow consumers to pay monthly utility bills using their cell phones through the Money on Mobile network of over 157,000 retail stores. Money on Mobile is the largest mobile payments company in India. Below is the list of new Money on Mobile alliances:
- Bihar Electricity Bill Payment: Roughly 20 million electricity consumers of North/South Bihar
- Reliance Energy Bill Payment : 2.8 million Consumers in Mumbai, India
- BEST Electricity Bill Payment: Roughly 1.0 million consumers in Mumbai
- Mahanagar Gas Limited: Approximately 700,000 MGL consumers in Mumbai and 1.5 million customers in Thane & Navi Mumbai.
- Tikona Bill Payment: Roughly 300,000 Mumbai consumers
About Money on Mobile
Money on Mobile is India’s largest mobile payment platform with 157,000 participating retail locations and over 67 million unique users since April, 2012. Money on Mobile is bringing quick, simple and efficient mobile payments to the Indian consumer.
About Calpian, Inc.
Calpian, Inc. (CLPI) is a publicly traded company with corporate offices in Dallas, Texas, operating centers in Georgia, and New York and mobile payments emerging-market operations through its subsidiary in India. Calpian’s Indian subsidiary offers Money-on-Mobile, a pre-paid mobile payment solution, to more than 157,000 Indian retail locations. Calpian’s management team has over 70 years in combined experience in the payments business. Please visit our website at www.calpian.com
(LXRX) Achieves Positive Results in Type 2 Diabetes Patients with Renal Impairment
THE WOODLANDS, Texas, Oct. 1, 2013 — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that LX4211, a first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), successfully met the primary endpoint of reducing post-prandial glucose, in a study of patients with type 2 diabetes and moderate to severe renal impairment. Reducing elevated post-prandial glucose, high blood sugar levels after meals, is a key objective of diabetes therapy.
In a placebo-controlled, proof-of-concept study, LX4211 provided clinically meaningful and statistically significant reductions (p<0.05) in post-prandial glucose in diabetes patients with moderate to severe renal impairment (Stage 3 and 4 kidney disease). Importantly, these effects were maintained in a sub-group with the most advanced renal impairment, pre-defined as those with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2. LX4211 also produced significant elevations in GLP-1, a hormone involved in control of glucose and appetite.
Renal impairment occurs in approximately 30% of patients with type 2 diabetes and represents a major unmet medical need with limited treatment options. LX4211’s inhibition of SGLT1 in the gastrointestinal (GI) tract, reducing glucose absorption and triggering GLP-1 secretion, offers the potential for treating this medically challenging population with compromised kidney function. In previous Phase 2 studies, LX4211 improved glycemic control in patients with type 2 diabetes with normal renal function.
“Our hypothesis was that LX4211 would improve glycemic control even in patients with the greatest degree of renal impairment due to its inhibition of SGLT1 in the GI tract,” said Pablo Lapuerta, M.D., Lexicon’s chief medical officer. “The post-prandial glucose reductions and GLP-1 elevations observed in this study population support the rationale for demonstrating effective HbA1c reduction in a larger, longer-term Phase 3 trial, and provide further support for the clinical differentiation of LX4211 as a first-in-class dual SGLT1 and SGLT2 inhibitor.”
In this multicenter study, 30 patients with poorly controlled type 2 diabetes and moderate to severe renal impairment were randomized to either placebo or a 400 mg dose of investigational drug LX4211 taken orally once per day before breakfast. Patients’ post-prandial glucose was measured after a standardized meal both at baseline before treatment and after one week of therapy. In addition to achieving the primary efficacy objective of post-prandial glucose reduction, there were no serious adverse events observed in the study and no discontinuations of LX4211 due to adverse events. Lexicon plans to present full results of the study at scientific congresses in 2014.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX4211, characterizations of the results of and projected timing of clinical trials of LX4211, and the potential therapeutic and commercial potential of LX4211. The press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
(RVLT) Provides Business Update
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a leader in advanced LED lighting technology, today provided a business update following President and Chief Financial Officer Charlie Schafer’s presentation at Craig-Hallum’s 4th Annual Alpha Select Conference on September 26, 2013 in New York City.
Key highlights of Schafer’s presentation and Revolution Lighting’s financial performance included:
- A robust pipeline of $150M in actionable opportunities over the next three to twelve months
- Expected organic growth of greater than 50% for 2014-2016
- Target gross margins of 35% or greater for 2014-2016
- Expected pro forma revenue of approximately $17M for the second half of 2013
- Expected full year pro forma 2013 revenue of approximately $35M
- Adjusted EBITDA margins of 15% or greater for 2014-2016
Schafer indicated that pro forma revenue for the second half of 2013 will be approximately $17 million. As a result of certain international orders coming in later than expected, third quarter revenue is expected to be between $5-6 million and fourth quarter revenue is expected to be in excess of $10 million. Pro forma revenue for all of 2013 is expected to total approximately $35 million after giving effect to the Relume and Seesmart acquisitions, representing 100% organic growth over 2012 pro forma revenues.
Schafer added, “2013 has been a successful year for Revolution Lighting. We expanded our distribution network and completed the acquisition of Relume Technologies, which broadened our product portfolio, and strengthened our engineering and management capabilities. We are now well-positioned for the anticipated growth to come in 2014 and beyond.”
Schafer’s presentation and live audio webcast are accessible via the Revolution Lighting website at the following link: http://ir.rvlti.com/ir-calendar
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. is a leader in the design, manufacture, marketing, and sale of light emitting diode (LED) lighting solutions focusing on the industrial, commercial and government markets in the United States, Canada, and internationally. Through advanced technology and aggressive new product development, Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive advanced product platform. The company goes to market through its Seesmart brand, which designs, engineers and manufactures an extensive line of high-quality interior and exterior LED lamps and fixtures; Lighting Integration Technologies Inc., which sells and installs Seesmart products; Lumificient, which supplies LED illumination for the signage industry; Relume Technologies, a leading manufacturer of outdoor LED products; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting Technologies markets and distributes its product through a network of independent sales representatives and distributors, as well as through energy savings companies and national accounts. Revolution Lighting Technologies trades on the NASDAQ under the ticker RVLT. For additional information, please visit: www.rvlti.com.
Cautionary Statement for Forward-Looking Statements
Certain of the above statements contained in this press release are forward-looking statements that involve a number of risks and uncertainties, including the anticipated benefits of the Relume acquisition and statements relating to the anticipated future growth and profitability of our business. Such forward-looking statements are within the meaning of that term in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Reference is made to Revolution Lighting’s filings under the Securities Exchange Act for additional factors that could cause actual results to differ materially, including our history of losses, the potential for future dilution to our existing common stockholders, our status as a controlled company, the risk that demand for our LED products fails to emerge as anticipated, competition from larger companies, and risks relating to third party suppliers and manufacturers, as well as the other Risk Factors described in Item 1A of our Form 10-K for the fiscal year ended December 31, 2012. Revolution Lighting Technologies, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those indicated in the forward-looking statements as a result of various factors. Readers are cautioned not to place undue reliance on these forward-looking statements.
Adjusted EBITDA
We use Adjusted EBITDA as a non-GAAP measure of financial performance. Adjusted EBITDA is calculated by adding back to net income or loss interest and financing related transactions, acquisition related transactions, income taxes, depreciation and amortization, asset impairments, stock based compensation charges, and severance and transition costs. Adjusted EBITDA is provided to investors to supplement the results of operations reported in accordance with GAAP. Management believes that Adjusted EBITDA is useful to help investors analyze the operating trends in the business and to assess the relative underlying performance of businesses with different capital and tax structures. Management believes that Adjusted EBITDA provides an additional tool for investors to use in comparing our financial results with other companies that use Adjusted EBITDA in their communications with investors. By excluding non cash charges such as amortization and depreciation, stock based compensation, asset impairments as well as non operating charges for income taxes, interest and financing charges, acquisition related and severance and transition costs charges investors can evaluate our operations and compare our results with the results of other companies on a more consistent basis. Management also uses Adjusted EBITDA to evaluate potential acquisitions, establish internal budget and goals and evaluate the performance of business units and management.
We consider Adjusted EBITDA to be an important indicator of our operational strength and performance and a useful measure of historical and prospective trends. However there are significant limitations of the use of Adjusted EBITDA since it excludes interest income and expenses, financing related and acquisition related transactions and severance and transition costs, income taxes, all of which impact profitability, as well as depreciation and amortization related to the use of long lived assets that benefits future periods. We believe that limitations are compensated by providing Adjusted EBITDA only with GAAP performance measures and clearly identifying the differences between the two measures. Consequently, Adjusted EBITDA should not be considered in isolation or as a substitute for net income or loss or operating income or loss presented in accordance with GAAP. Moreover, Adjusted EBITDA as defined by the Company may not be comparable to similarly titled measure provided by other entities.
(HOTR) Closes Acquisition of American Roadside Burgers
Acquisition Adds Five New Locations to HOTR’s Growing Restaurant Portfolio
CHARLOTTE, NC–(October 01, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or the “Company”), headquartered in Charlotte, N.C., announced today that the Company has purchased all of the outstanding shares of American Roadside Burgers, Inc (“ARB”). ARB is a Charlotte, N.C. based chain of 5 casual restaurants known for serving high-quality Premium beef burgers, providing value to its customers. Subject to Board and regulatory agency approvals, Tom Lewison, a current Director of American Roadside Burgers and the former Chief Operating Officer of Bojangles, will join the Chanticleer Holdings Board of Directors and provide strategic direction for the companies.
Mike Pruitt, Chairman and Chief Executive Officer of the Company, stated: “This acquisition of an exciting chain of restaurants is our first departure from our ongoing development of Hooters restaurants in foreign countries. We believe that acquiring American Roadside at this stage of their development presents Chanticleer a strategic opportunity to participate in a high-growth space with an already established brand. We plan to continue to expand the American Roadside chain as future opportunities occur as well as continue on our development of Hooters restaurants internationally. Additionally, the opportunity to work with one of the better restaurant executives in the country, Tom Lewison, is an extremely important step in our corporate transformation.”
ARB, a 10-year-old chain is known for its diverse menu featuring fresh salads; customized burgers made from fresh beef, turkey or veggies; milk shakes; and a large selection of various sandwiches, beers and wine. In-restaurant dining is fast and convenient and the existing restaurant locations are strategically located in high traffic areas. Each restaurant features a nostalgic “made in America” theme.
The first American Roadside Burgers location opened in 2006 in Smithtown, N.Y. Since then it has expanded to 2 locations in Charlotte, N.C., 1 location in Columbia, S.C. and the newest location is in Greenville, S.C. It was founded in 2003 by John Tunney, III, a nationally renowned creator of award winning restaurants throughout the United States.
About Chanticleer Holdings, Inc.
Chanticleer Holdings (HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets. Chanticleer currently owns in whole or part of the exclusive franchise rights to develop and operate Hooters restaurants in South Africa, Hungary and parts of Brazil, and has joint ventured with the current Hooters franchisee in Australia, while evaluating several additional international opportunities. The Company currently owns and operates in whole or part of six Hooters restaurants in its international franchise territories: Durban, Johannesburg, Cape Town and Emperor’s Palace in South Africa; Campbelltown in Australia; and Budapest in Hungary.
In 2011, Chanticleer and a group of noteworthy private equity investors, which included H.I.G. Capital, KarpReilly, LLC and Kelly Hall, president of Texas Wings Inc., the largest Hooters franchisee in the United States, acquired Hooters of America, a privately held company. Today, Hooters of America is an operator and the franchisor of over 430 Hooters® restaurants in 28 countries. Chanticleer maintains a minority ownership stake in Hooters of America and its CEO, Mike Pruitt, is also a member of Hooters’ Board of Directors.
For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
About American Roadside Burgers, Inc.
For further information on American Roadside Burgers, Inc., visit http://americanroadside.com
For further information on Hooters of America, visit www.Hooters.com
Facebook: www.Facebook.com/Hooters
Twitter: http://Twitter.com/Hooters
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.
Mike Pruitt
Chairman/CEO
Phone: 704.366.5122 x 1
mp@chanticleerholdings.com
(ZAZA) Second Transaction with JV Partner In Eaglebine/Eagle Ford East
JV Partner Accelerates Joint Venture Phases and Exchanges Acreage and Production ZaZa to Receive $16.5 MM Net Cash Plus Production Interests in 23 Wells (~$16.1 MM PDP)
ZaZa Energy Corporation (“ZaZa” or the “Company”) (NASDAQ:ZAZA) today announced that it has signed a Second Amendment and First Restatement of Joint Exploration and Development Agreement (the “Agreement”) with its current joint venture partner, one of the largest independent crude oil and natural gas companies in the United States, to further develop and expand its Eaglebine/Eagle Ford East assets.
TRANSACTION HIGHLIGHTS
- Acceleration of Phase II. ZaZa’s joint venture partner has elected into Phase II ahead of the schedule set forth in the original agreement. As consideration for the Phase II election, ZaZa will receive (i) $17 MM in cash consideration and (ii) interests in 15 of its venture partner’s wells outside of the Area of Mutual Interest (“AMI”) line in Madison County (the “Southern Madison Wells”) with a PDP present value of $3 MM based on an independent reserves report. In addition to the preceding, ZaZa will receive 100 percent carry consideration for one (1) vertical well completion, two (2) horizontal well completions and a $1.25 MM credit towards miscellaneous land or operational expenses. In return, ZaZa will assign to its joint venture partner 20,000 net Phase II acres. The Company also continues to anticipate timely drilling and completion of three (3) carried Phase I obligation wells.
- Acceleration of Phase III. As consideration for the assignment of at least 6,000 net former Phase III acres, ZaZa will receive additional interests in the Southern Madison Wells with an incremental PDP present value of approximately $9 million based on an independent reserves report. Pro forma for this transaction, ZaZa will retain approximately 14,000 net Phase III acres, and its joint venture partner has the option to elect into some or all of this acreage on or before January 31, 2014, by making a further cash payment to ZaZa. The original agreement called for a Phase III election by January 31, 2015.
- Acreage and Production Exchange. The Company’s joint venture partner will assign to ZaZa (i) a 25 percent working interest in approximately 19,000 net additional acres recently acquired by its venture partner in the Agreement’s AMI and (ii) related AMI interests in multiple producing wells with a PDP present value of approximately $4.1 MM. The Company also expects additional production in the near future from two (2) recently drilled wells, in various stages of completion, within this newly assigned acreage. In return for the 25 percent working interest and immediately available production, ZaZa will pay $2 MM and assign a 75 percent working interest in approximately 18,500 net acres of its retained acreage position in Walker and Madison Counties, Texas.
MANAGEMENT COMMENTS
According to Todd A. Brooks, ZaZa’s President and CEO, “This is a significant step forward for our company as we establish our production base and create the right platform for growth. Through this transaction we’ve successfully increased our contiguous JV acreage footprint, established $16.1 million in PDP value across interests in 23 producing wells and will see an influx of $16.5 million in net cash. I look forward to providing investors with operational updates as the joint venture progresses.”
About ZaZa Energy Corporation
Headquartered in Houston, Texas, ZaZa Energy Corporation is a publicly-traded exploration and production company with primary assets in the Eagle Ford and Eaglebine/Eagle Ford East resource plays in Texas. More information about the Company may be found at www.zazaenergy.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by words such as “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “forecasts” and similar references to future periods. These statements include, but are not limited to, statements about ZaZa’s ability to execute on exploration, production and development plans, estimates of reserves, estimates of production, future commodity prices, exchange rates, interest rates, geological and political risks, drilling risks, product demand, transportation restrictions, actual recoveries of insurance proceeds, the ability of ZaZa to obtain additional capital, and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission. While forward-looking statements are based on our assumptions and analyses that we believe to be reasonable under the circumstances, whether actual results and developments will meet our expectations and predictions depend on a number of risks and uncertainties that could cause our actual results, performance and financial condition to differ materially from our expectations. See “Risk Factors” in our 2012 Form 10-K and 2013 First and Second Quarter Form 10-Q filed with the Securities and Exchange Commission for a discussion of risk factors that affect our business. Any forward-looking statement made by us in this news release speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future development, or otherwise, except as may be required by law.
(OINK) Announces $3.2 Million Private Placement Transaction
WUHAN, China, Sept. 30, 2013 — Tianli Agritech, Inc. (NASDAQ:OINK) (“Tianli” or the “Company”), a leading producer of breeder hogs, market hogs and black hogs, headquartered in Wuhan City, China, today announced that the Company has agreed to sell 2,760,000 shares of its common stock at a price of $1.16 per share ($3.2 million in the aggregate) to Mr. Wei Gong (the “Investor”), a citizen of the PRC. The offering price represents an approximately 43% premium over Tianli’s share price at last Friday’s market close of $0.81.
To comply with Nasdaq Marketplace Rule 5635(d) which limits the number of shares of the Company’s common stock that can be sold in a private placement to no more than 20% of the 11,194,000 shares outstanding, subject to certain exceptions as provided in the Nasdaq Marketplace Rules, the Company sold 2,238,000 shares of its common stock to the Investor for a total consideration of $2,596,080 on September 28, 2013. The balance, 522,000 shares with a total consideration of $605,520, is expected to be completed within three days after the first to occur of (1) the receipt by the Company from Nasdaq of an acknowledgement that it is exempt from Marketplace Rule 5635(d) or (ii) the receipt by the Company of a vote of its shareholders approving the sale by the Company to the Investor of a number of shares greater than 20% of the shares currently outstanding.
Mrs. Hanying Li, Chairwoman and CEO of Tianli Agritech commented, “We are very pleased to welcome Mr. Wei Gong to be a substantial shareholder of Tianli and appreciate the support of our new and existing investors. As a prominent investor, a prolific author, and one of the pioneers of incubation centers in China, Mr. Gong currently serves as the Director of Wuhan East Lake Hi-tech Innovation Center, a position he has been holding since 1987. We believe the value of having Mr. Gong as our substantial shareholder is both financial and strategic and expect to benefit tremendously from Mr. Gong’s involvement in our business.”
Mr. Wei Gong stated, “We believe China’s continuing transition from export- and investment- driven growth to domestic consumption-driven growth bodes well for the hog industry. With its well established market position, steadily growing Black Hog Program in Enshi Prefecture, and quickly expanding retail presence, in our view Tianli is well positioned to further strengthen its leading market position in the Wuhan market and take full advantage of the growing trend in pork consumption in China. With the stock trading at just 0.2x of its book value, we are thrilled to have the opportunity to take a large position in the Company at a very reasonable price. We look forward to a mutually beneficial relationship with Mrs. Li and the Tianli team for many years to come.”
About Tianli Agritech, Inc.
Tianli Agritech, Inc. is in the business of breeding, raising and selling breeder and market hogs in China and is developing a retail channel for its pork products including high-value, black hog meat. The Company is focused on growing high quality hogs for sale for breeding and meat purposes. The Company conducts genetic, breeding and nutrition research to steadily improve its production capabilities.
Forward-Looking Statements
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by this cautionary statement and any other cautionary statements which may accompany the forward-looking statements. In addition, the company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
For more information, please contact:
Tina Xiao
Weitian Group LLC
Phone: +1-917-609-0333
Email: tina.xiao@weitian-ir.com
Web: http://www.weitian-ir.com
(CNR) Announces Aug 29 Groundbreaking Ceremony in Hengyang, Hunan Province
NEW YORK, NY–(Aug 30, 2013) – China Metro-Rural Holdings Limited (NYSE MKT: CNR) (the “Company”) is pleased to announce attendance of groundbreaking ceremony of its latest project in Hengyang Province (the “Hengyang Project”) invited by the Hengyang Government on August 29, 2013.
Prior to the groundbreaking ceremony, on August 28, 2013, the Secretary of Communist Party of China of Hunan Provincial Committee Mr. Xu Shousheng and the Governor of Hunan Province Mr. Du Jiahao have granted an interview with founding shareholders of the Company, the Chairman and CEO of the Company and senior management of the Hengyang Project company. Both Mr. Xu and Mr. Du have expressed that the Hengyang Project is highly important for the economic development of Hunan Province and the Hunan Government will provide all necessary supports for the development of the Hengyang Project.
The guests for the groundbreaking ceremony included Vice-Governor of Hunan Province, the Mayor of Communist Party of China of Hengyang Municipal Committee and the Mayor of Hengyang City. “With the assistance provided by the local government, we have already acquired approximately 2,000,000 square meters of land through auction for our development,” Sam Sio stated, CEO and Chairman of the Company.
The planned site area of the Hengyang Project is approximately 2.7 million square meters with corresponding maximum gross floor area of approximately 7.5 million square meters. The Hengyang Project will include trading outlets and other supporting facilities such as exhibition centres, residential and commercial areas. The development duration is expected to take approximately 10 years for the entire project.
ABOUT CHINA METRO-RURAL HOLDINGS LIMITED
China Metro-Rural Holdings Limited is a leading agricultural logistics platform development and rural-urban migration redevelopment company in China.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are, by their nature, subject to risks and uncertainties. This Act provides a “safe harbor” for forward-looking statements to encourage companies to provide prospective information about themselves so long as they identify these statements as forward-looking and provide meaningful cautionary statements identifying important factors that could cause actual results to differ from the projected results. All statements, including statements regarding industry prospects and future results of operations or financial position, made in this press release are forward looking.
Words such as “continue”, “consider”, “probably”, “will”, “strive” and similar expressions may identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to: the Company’s future performance, the Company’s expansion efforts, the state of economic conditions, the Company’s market and the governmental policy. These forward-looking statements are based on assumptions and analyses made by the Company in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors the Company believes to be appropriate in particular circumstances. However, whether actual results and developments will meet the Company’s expectations and predictions depends on a number of known and unknown risks and uncertainties and other factors, any or all of which could cause actual results, performance or achievements to differ materially from the Company’s expectations, whether expressed or implied by such forward-looking statements.
CONTACT:
China Metro-Rural Holdings Limited
Investor Relations Department
Phone: (852) 2111 3815
E-mail: Email Contact
(PTOO) PITOOEY!, Inc. Provides Focused Social Media Advertising
PHOENIX, AZ–(Sep 30, 2013) – PITOOEY!™, Inc. (OTCBB: PTOO) (the “Company”) is a complete digital marketing agency that specializes in social media advertising through services like Facebook, Twitter, YouTube and Instagram.
Use of social media continues to explode, with Facebook reporting over 1 billion monthly active users. Social media allows advertisers to reach a massive worldwide audience, as well as provides the ability to deliver laser-focused advertising. According to industry experts, global social advertising revenues are projected to reach $14 billion by 2014. Smart advertisers are turning their attention to social media, and, as a result, the Company reported record revenues and an ongoing expansion in its customer base.
According to Company executives, there is significant evidence that many business customers are aware of or have previously used social media to attract new customers. “Unfortunately, business owners have little time to dedicate to maintaining a presence on every social media platform in existence,” commented CEO, Jacob DiMartino. “PITOOEY! is here to provide businesses a focused approach to social media so that businesses can increase brand awareness, engage with consumers and drive sales.”
PITOOEY! and its subsidiaries have over 30 full-time employees dedicated to consulting and assisting businesses in delivering a cohesive and effective social media advertising campaign.
About PITOOEY!™, Inc.
PITOOEY!, Inc., via its wholly owned subsidiaries PITOOEY! Mobile, Inc. and Choice One Mobile, Inc., is a complete digital marketing agency offering businesses unique service packages based on the client’s requests. These requests, including the type of following or reach desired, are filtered through the Company’s subsidiaries to provide the perfect fit.
For more information, please visit:
www.PitooeyInc.com
www.Pitooey.com
www.ChoiceOneMobile.com
Safe Harbor
This release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of PITOOEY!, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy. The words “may,” “would,” “will,” “expect,” “estimate,” “can,” “believe,” “potential” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond PITOOEY!, Inc.’s ability to control and their actual results may differ materially from those projected in the forward-looking statements as a result of various factors. More information about the potential factors that could affect the business and financial results is and will be included in PITOOEY!, Inc.’s filings with the Securities and Exchange Commission.
For further information contact:
PITOOEY!, Inc.
Corporate Communications
Phoenix, AZ
www.PitooeyInc.com
480-999-6025
investorrelations@pitooey.com
(FNRG) Partners with the Louisiana Nursing Home Association Over LED Lighting
Market Comprised of 80,000 US Nursing Homes and Long-Term Care Establishments
NEW YORK, NY (September 30, 2013) ForceField Energy Inc. (“ForceField”) (OTCQB: FNRG), an international manufacturer, seller and distributor of energy products and solutions, today announced the signing of a consulting and sales agreement for LED lighting products with LNHA Service Corporation servicing the Louisiana Nursing Home Association’s Member (“LNHA”), a non-profit federation representing more than 250 nursing facilities and assisted living communities that care for approximately 30,000 elderly and disabled individuals. LNHA will support the marketing and sales efforts with its existing members, as well as, assist in penetrating the approximate 80,000 U.S.-based nursing homes and long-term care establishments with combined annual revenues approximating $200 billion.
Many LED adopters have based their decision largely on safety aspects. The typical nursing home’s lighting is often inadequate and does not meet the needs of its residents. Furthermore, leading medical studies on major depressive disorders in elderly individuals have shown that using bright light treatment may improve mood, sleep, and hormonal rhythms in these patients. Better lighting in nursing homes could potentially enable residents to be more independent, while simultaneously reducing the demand on the facility’s staff.
Myron Chatelain, LNHA’s Service Corporation Manager remarked, “Improving staff efficiency, lowering operating costs, and enhancing safety first provide significant value to long-term care facility operators and their residents, and second addresses the key challenges that the industry faces as a result of the increased health needs of its residents and reimbursement pressures. In the light of these challenges and through the significant benefits available with LED lighting, we are confident that by partnering with ForceField we can accelerate the adoption of LED lighting in the market.”
Richard St-Julien, ForceField Energy’s Chairman commented, “The long-term care and healthcare markets represent significant opportunities given the continued aging of the general, domestic population and the push for greater efficiency by healthcare providers. With their more than 55 years of industry experience, we are proud to partner with a respected leader such as LNHA that clearly understands the needs of both the patients and facility of long-term care facilities. We are confident that the insight and accessibility LNHA brings to this partnership will enable us to increase awareness as to the many benefits of LED lighting and provide us with significant revenue opportunities for our products and services.”
About the US Nursing Home and Long Term Care Industry
The US nursing homes and long-term care facilities industry includes about 80,000 establishments (single-location companies and branches of multi-location companies) with combined annual revenue of about $200 billion. A key driver of demand is the aging population. Between 2015 and 2030, the number of Americans 65 and over is expected to increase to around 72 million (Based on First Research, a division of Hoover’s Inc.). According to the Center for Medicare and Medicaid Services, persons 75 years of age and older spend 60% more on healthcare than those 65-74 and 200% more than the population average. An increase in the number of older Americans is expected to fuel a large increase in demand for health care services and health care properties.
Demand for nursing care is linked to the demographics of the US population. The profitability of individual nursing facilities depends on efficient operations, as revenue per patient is largely controlled by the government insurance programs, Medicare, and Medicaid. Large companies have some economies of scale in administration and purchasing, but small operators can compete effectively by offering better service. The US industry is fragmented: the 50 largest companies account for about 20 percent of revenue.
About Louisiana Nursing Home Association (LNHA)
LNHA was founded in 1957 on the premise that members have a moral obligation to the residents they serve. LHNA is a non-profit federation representing more than 250 non-profit and for-profit nursing facilities and assisted living communities that care for approximately 30,000 elderly and disabled individuals each day. On behalf of our members, LNHA advocates for providing quality care and nurturing environments to Louisiana’s frail and elderly. LNHA is dedicated to serving the needs of our membership by providing public policy advocacy, education, professional development, quality initiatives and various other services. These tools allow members to offer the highest practicable measure of care to their residents. http://www.lnha.org/
About ForceField Energy, Inc.
ForceField Energy is a global company whose products and solutions focus on renewable energy and improved energy efficiency. ForceField’s subsidiary, TransPacific Energy Inc. (“TPE”) has patented a technology which uses proprietary multiple component fluids that are environmentally sound, non-toxic and non-flammable. Custom formulated mixtures efficiently capture and convert heat directly from the heat source at temperatures ranging from 75° F to 950° F. TPE’s technology offers applications at broader temperature ranges than other energy recovery systems. TPE’s systems in certain applications reduce operating and maintenance costs thereby significantly improving return on capital expenditures thus making the purchase of waste heat recovery systems which previously yielded nominal savings, economically viable. ForceField is the exclusive distributor in the U.S., Canada, Mexico, Latin America, and the Caribbean of Light Emitting Diode (“LED”) commercial lighting products and fixtures for a premier LED manufacturer, Lightsky. An LED is a semiconductor device which converts electricity into light. The LED light is considered “green” because of the absence of dangerous chemicals and an accompanying significant reduction in energy consumption depending on the application, from 50% to 70% of traditional lighting products.
ForceField is a distributor for PowerOneData International, Inc. a company that provides Advanced Metering Infrastructure and ASLM solutions to the international energy markets, reducing energy resource consumption and its negative impact on the environment and public health ForceField is also a significant manufacturer and distributor of trichlorosilane (“TCS”) in China. TCS is a specialty chemical primarily used in the production of polysilicon, which is an essential raw material in the production of solar cells for PV panels that convert sunlight to electricity. TCS is considered to be the first product in the solar PV value chain before polysilicon, and is also the principal source of ultrapure silicon in the semiconductor industry. For additional information regarding ForceField Energy Inc. or Transpacific Energy, Inc., please visit the companies’ websites at http://www.forcefieldenergy.com/, www.transpacenergy.com, www.lightsky-led.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward-looking. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “future,” “plan” or “planned,” “expects” or “projected.” These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company’s control that may cause actual results to differ materially from stated expectations. Some of the factors that could cause actual results to differ materially from the forward-looking statements contained herein include i) the Company’s ability to generate significant revenues and profits from its waste heat technology and LED lighting segments, (ii) the Company’s ability to obtain adequate financing to achieve its LED and waste heat technology business plan (iii) the successful installation and efficacy of the Company’s LED lighting products (iv) a decision by LNHA’s members to purchase LED lighting, (v) the ability of LNHA’s members to finance the purchase of LED lighting (vi) other factors without limitation which are detailed in documents we file from time to time with the Securities and Exchange Commission, which are available at www.sec.gov.
Contact information
ForceField Energy Inc.
Richard ST Julien
212-672-1786
www.ForceFieldenergy.com
Mission Investor Relations
Sherri Franklin
404-941-8975
www.MissionIR.com
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009