|News Bytes: XOMA, InterMune, Dara BioSciences, Genvec|
|By Staff and Wire Reports|
|Wednesday, 04 November 2009 09:03|
There are four companies likely to move on news today and they include XOMA Ltd. (Nasdaq:XOMA) which is involved in the discovery and development of therapeutic antibodies. Today they announced plans to initiate an investigator sponsored Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients.The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. The trial sponsor is Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052. XOMA will provide XOMA 052 drug product for the trial.
As many as 3 million Americans may have Type 1 diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the patient's own immune system destroys the patient's beta cells in their pancreas that normally control blood sugar level. Patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump every day for the rest of their lives. And even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
In addition, XOMA announced the grant of its first European Patent related to the XOMA 052 program. Granted by the European Patent Office, the patent covers XOMA's interleukin-1 beta (IL-1 beta) antibody XOMA 052, as well as nucleic acids, expression vectors and production cell lines for the manufacture of XOMA 052. The patent provides exclusivity in Europe into 2026.
InterMune, Inc. (Nasdaq: ITMN) has announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."
DARA BioSciences, Inc. (Nasdaq:DARA) has announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 12/112,213 entitled "Methods for Decreasing or Preventing Pain Using Spicamycin Derivatives." When issued, the patent will allow protection through 2021. DARA BioSciences has exclusive licenses with Massachusetts General Hospital and Kirin Pharmaceuticals of Japan for the treatment of pain with Spicamycin derivatives.
Earlier this year, the company successfully completed a clinical proof-of-concept study for the treatment of neuropathic pain in patients with advanced cancer using KRN5500. The results of this Phase 2 study will be presented as a poster, "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain Intensity in Patients with Cancer" at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain to be held in San Francisco, November 19-21, 2009. Sharon M. Weinstein, MD, a leading investigator in the study, will present the poster.
GenVec, Inc. (Nasdaq: GNVC) has announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TNFerade(TM) for the treatment of pancreatic cancer.
"Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits," stated Dr. Paul Fischer, GenVec's President and CEO.
The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation provides potential financial and regulatory incentives including study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval.