|Vertex's Data from Phase 2 VX-809 Study Supports Plan for Program in Early 2013; Pfizer Announces Top-Line Results From Phase 3 ALO-02|
|By Staff and Wire Reports|
|Thursday, 11 October 2012 18:14|
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced data from a Phase 2 study of VX-809 combined with ivacaftor in people with the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del, will be presented by lead study investigator Michael P. Boyle, M.D., F.C.C.P., Associate Professor, Director of the Johns Hopkins Adult Cystic Fibrosis Center, at the 26th Annual North American Cystic Fibrosis Conference (NACFC), in Orlando, Fla., October 11 to 13, 2012. The oral presentation will take place today at 11:40 a.m. EDT.
Final study results, announced in June 2012, support Vertex's plans to initiate a pivotal program in early 2013, which is expected to evaluate VX-809 in combination with ivacaftor in people with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation, pending discussions with regulatory agencies.
Pfizer (NYSE: PFE) announced top-line results today from a Phase 3 open-label long-term safety study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, non-cancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations; the most common adverse events were nausea, constipation, vomiting and headache. The study supports the safety profile of this investigational analgesic.
ALO-02 uses technology designed to encourage use as intended. The technology may discourage common methods of tampering associated with prescription opioid misuse and abuse and consists of extended-release oxycodone pellets that surround a sequestered core of naltrexone. When used as directed, the naltrexone core remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed, the naltrexone is released and is designed to counteract the effects of oxycodone.
“These top-line data provide evidence of the long-term safety of ALO-02 in patients with moderate-to-severe non-cancer pain regardless of prior prescription opioid treatment,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.
Study ALO-02-10-3001 included adult patients with moderate-to-severe chronic non-cancer pain lasting at least 3 months and requiring a continuous around-the-clock opioid analgesic for an extended period of time. Before enrolling in the study, subjects could be receiving a prescription opioid for the management of chronic pain or could be opioid-naïve. The primary objective of this single-arm, multicenter, safety study was to evaluate the long-term safety of ALO-02 administered once or twice daily for up to 12 months. The study enrolled 395 patients, the majority of whom – 77 percent – were opioid-experienced. The majority of patients had chronic lower back pain (61 percent) and 18 percent had pain from osteoarthritis. Patients enrolled in the study had pain for an average of nine years. A total of 193 (48.9%) patients received ALO-02 for approximately 6 months and 105 (26.6%) patients for approximately one year.
The most common treatment-emergent adverse events (>10%) while on ALO-02 were nausea, constipation, vomiting and headache. The most common serious adverse events were acute myocardial infarction, non-cardiac chest pain, pneumonia, convulsion, and kidney stones, each of which occurred in 2 patients. A total of 237 (60%) patients discontinued from the study over the one-year study period, with 19 percent of patients reporting adverse events as the primary reason for discontinuation. The adverse events that most commonly (>2%) lead to discontinuation were nausea and constipation. The discontinuation rate was within the expected range based on similar long-term safety studies with other extended-release opioid formulations.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centred on its proprietary anti-apoptotis therapeutic protein MANF, today announced that it has acquired an exclusive option to license the LymPro Alzheimer's Diagnostic Blood Test from Memory Dx, LLC (MDx), formerly known as Provista Life Sciences, LLC.
Amgen (NASDAQ: AMGN) announced that on Oct. 10, 2012, its Board of Directors declared a $0.36 per share dividend for the fourth quarter of 2012.
AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque and to safely improve lipid profiles in humans, today announced that it has closed a sale to accredited investors of an aggregate of 5,850,000 units, which are composed of one share of the Company's common stock and a warrant to purchase 0.5 shares of common stock.
BioElectronics Corporation (BIEL: OTCPK), maker of consumer medical electronics products for pain management announced that Andrew J. Whelan, President, was featured on 'The Stocks and Jocks Radio' show to describe the Company's rapid international expansion, its US FDA market clearance progress, recent published medical journal articles, new clinical studies, and the availability of ActiPatch® on Amazon.co.uk in Europe, where its customer's product satisfaction is 97%.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the third quarter 2012 on Tuesday, November 6, 2012, after the close of the market.
Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a leading developer of biologically active regenerative therapies, today announced that safety data from the first 10 patients in the Phase II RECOVER-Stroke study of ALD-401, a unique and differentiated stem cell population derived from patients' own bone marrow, are being presented today at the World Stroke Congress in Brazil.
eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families, and small businesses, announced today that the company plans to release third quarter 2012 financial results on October 25, 2012.
Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) announced today that on October 10, 2012, Elbit Medical Technologies Ltd. ("Elbit Medical") (TASE: EMTC-M) (in which the Company holds approximately 90%), and InSightec Ltd. ("InSightec") (in which Elbit Medical holds approximately 64.3%, and 53% on a fully diluted basis), have entered into a share purchase agreement (the "Investment Agreement") with GE Healthcare (a division of GE Company) ("GE") and certain other shareholders of InSightec (the "Other Investors"), pursuant to which GE and the Other Investors shall invest an amount of approximately US$ 31.4 million in InSightec (the "Transaction").
Emergent BioSolutions Inc. (NYSE: EBS), a global biopharmaceutical company based in Maryland, USA, has selected the QUMAS Compliance Platform to manage regulatory documents and quality processes across the organization.
Golden Age Resources, Inc. (PINKSHEETS: GDAR) announced today that it has entered into a Letter of Intent to acquire 100% of the issued and outstanding stock of Griffin Holdings and IT Solutions, Inc.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today called attention to an article about health IT featured this week in CivSource that focused on MMR's health IT patent portfolio and implications to government-supported initiatives.
Rapid Fire Marketing (PINKSHEETS: RFMK), a developer, producer and distributor of vapor inhalers, is proud to announce that its company representative, Cheryl Shuman, will head Rapid Fire Marketing's rebuild and rebrand of Medical Cannabis Management (MCM).
Revolutions Medical Corporation (OTCQB: RMCP) announced today that the Company will exhibit at the Chicago Hyatt Regency Convention Center for the 2012 Health Industry Distributors Association (HIDA), October 11-12.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that E. Robert Wassman, M.D. and Dganit Bar, Ph.D. will join the Company in the newly created positions of Chief Medical Officer and Chief Scientific Officer, respectively, as of October 22, 2012.
SunSi Energies Inc. ("SunSi") (OTCQB: SSIED) (OTCQB: SSIE), an international manufacturer, seller and distributor of energy products and solutions, today announced it has entered into an agreement with one of the largest private hospital groups in the U.S. to conduct a trial of SunSi's Lightsky LED lighting products at one of its facilities in the Midwest.