|OXiGENE Announces Agreement With FDA on Phase 3 Trial of ZYBRESTAT(R); Vaccine for Staph More Lethal Than Skin Cancer Tested|
|By Staff and Wire Reports|
|Monday, 17 September 2012 19:25|
OXiGENE, Inc. (NASDAQ:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that it has come to agreement with the U.S. FDA on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid cancer (ATC). The FACT 2 study is designed as a randomized, placebo-controlled, double-blinded study of 300 subjects randomized 1:1 to receive carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo. The primary endpoint of the study will be to compare the median overall survival between the two arms.
Commented Peter J. Langecker, M.D., Ph.D., President and Chief Executive Officer: "We appreciate the FDA's granting of the SPA for the pivotal FACT 2 trial of ZYBRESTAT in patients with anaplastic thyroid cancer. ATC is a tough disease tough for patients who are faced with dire prospects, tough for doctors who have very little to offer in terms of therapy to their patients, tough for the company trying to develop a novel treatment and even tough for regulators who see the need but who also have to see certain criteria met to be able to approve a drug. We want to thank the agency for their very thoughtful and constructive process.
"ATC is the indication for which we have the most compelling data, suggesting an overall survival benefit for patients who receive ZYBRESTAT along with carboplatin and paclitaxel chemotherapy and that is the reason for our continued pursuit of this indication. ATC is a very rare tumor from which most patients die within few months of initial diagnosis, and thus represents a significant unmet medical need. We are hopeful that the receipt of the SPA will strengthen our ability to obtain funding to conduct the FACT 2 study, either through financing or partnering. We believe that vascular disrupting agents can make a valuable contribution to anticancer therapeutic regimens, and we look forward to advancing our VDA programs not only in ATC, but also in ovarian cancer, carcinoid syndrome, myeloid leukemia and other potential indications."
Pfizer Inc. (NYSE:PFE) and GlaxoSmithKline Plc (NYSE:GSK), two of the world’s biggest drugmakers, and NovaDigm Therapeutics Inc., a closely held biotechnology company, are each testing novel vaccines to halt methicillin-resistant Staphylococcus aureus, or MRSA, face a dangerous infection in hospitals and nursing homes and which is now increasingly finding its way into daycare centers, schools and prisons.
The vaccines are in early studies and years away from possible approval. Two other drug companies have already tried and failed to make an effective vaccine, most recently Merck & Co. (MRK) in 2011. Still, as infections spread, doctors are eager for a vaccine that works.
“It’s very clear we need a vaccine, and we need it soon,” said Robert Daum, a pediatrics professor at the University of Chicago and principal investigator at the school’s MRSA Research Center, in a telephone interview. “The challenge is, we don’t really know what makes people immune to staph infections.”
Mostly benign Staphylococcus aureus bacteria live widely on people’s skin and in their nasal passages. About 1 percent of those with the bacteria carry MRSA, a toxic form of the illness that enters the bloodstream and is resistant to most treatments. MRSA, which kills more than 11,400 Americans a year, can enter the body through a cut, a sore, a catheter or a breathing tube.
Once infected, patients are typically treated with powerful antibiotics. The more these therapies are used, though, the more likely it is that the bacteria will develop resistance to them as well.
“Are they optimal? No,” said Frank Lowy, a pathology professor at Columbia University in New York, in a telephone interview. Thus the need for an effective vaccine.
Each of the experimental vaccines being developed take a different tack toward their goal of snuffing out the bacteria. Pfizer’s and Glaxo’s products attack on several biological fronts at once, following the model of HIV drug cocktails, while NovaDigm’s sparks an immune system response to kill the bug before it enters the body.
In hospitals, a vaccine would be used for patients going into surgery or those with compromised immune systems, Daum said. Beyond hospitals, people could get routine vaccinations to help protect them against proliferating staph bacteria in places like daycare centers for children and gym locker rooms.
AdCare Health Systems, Inc. (NYSE MKT: ADK), a leading long-term care provider, announced that on September 14, 2012 it filed a resale registration statement on Form S-3 with the Securities and Exchange Commission.
AMRI (NASDAQ: AMRI) announced today that it has entered into a new strategic agreement with Knopp Biosciences LLC, a drug discovery and development company focused on breakthrough treatments for unmet needs in neurological disorders.
Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX), www.connectyx.com, a Healthcare BPO that provides unique products for the healthcare market including MedFlash®, the electronic Personal Health Manager (ePHM), Medical Transcription, Disease Management, Revenue Cycle Management, and Medical Consulting - Billing, announced the acquisition of U.S.A. Medical Monitoring Services LLC, www.usaalertinfo.com, a profitable private company engaged in the Personal Emergency Response Systems/Services (PERS) market.
Intersil Corporation (NASDAQ: ISIL), a world leader in the design and manufacture of high performance analog and mixed signal semiconductors, today expanded its family of radiation hardened op amps with a quad precision version featuring the industry's best combination of low noise, low power consumption, high precision and high DC accuracy.
Life Technologies Corporation– (NASDAQ: LIFE) the world's leader in human identification solutions, today launched GlobalFiler™ and GlobalFiler™ Express, two new DNA kits that will revolutionize how crime labs perform forensic testing around the world -- making it faster, easier and cheaper to process DNA samples.
Lifeline Biotechnologies, Inc. (OTC Market: LLBO) announces the award of US Patent #8,231,542 B2 for System For Analyzing Thermal Data Based on Breast Surface Temperature to Determine Suspect Conditions.
ProPhase Labs, Inc. (NASDAQ: PRPH) (www.ProPhaseLabs.com) announced today that it previously received an unsolicited, non-binding proposal from Matrixx Initiatives, Inc. ("Matrixx") to acquire the Company for $1.40 per share in cash, subject to further due diligence by Matrixx.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that James M. Gower, the company's chairman and chief executive officer, is scheduled to present a company overview at the UBS Global Life Sciences Conference in New York City on Thursday, September 20th at 4:30 p.m. ET.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of a new test to assess a patient's viral load of cytomegalovirus (CMV).
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics, will host a conference call on Tuesday, October 2, 2012 at 10:00 a.m. Eastern (7:00 a.m. Pacific) to provide an update on the Company's business and respond to questions.
Synergetics USA, Inc. (NASDAQ: SURG) announced today that it will release summary financial results for the fourth quarter and the fiscal year 2012 before the market opens on Monday, October 1, 2012. At 9:30 a.m. Central Time (10:30 a.m. Eastern) of that day the Company will host a conference call to discuss financial results for its fourth fiscal quarter and fiscal year, ended July 31, 2012.
Walgreens (NYSE: WAG) (NASDAQ: WAG), the nation's largest drug store chain, and Rx Response, an initiative of the bio-pharmaceutical supply system, today announced a new health care collaboration developed to help ensure patient access to medications following a natural disaster.