GenVec's Pancreatic Cancer Treatment Assigned Orphan Drug Status – Stocks To Watch
11/4/2009 8:58:02 AM(RTTNews) GenVec, Inc. (GNVC) said the FDA has granted orphan drug designation to its pancreatic cancer treatment – TNFerade, which is also the company's lead product candidate.
Orphan drug designation for a drug provides the sponsor of the study with 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 approval.
The drug has also been assigned a Fast Track designation for the pancreatic cancer indication that will cut the drug review time to 6 months instead of the standard 10-months it generally takes.
TNFerade is currently in Phase III testing for pancreatic cancer, a disease for which there is no effective therapy. The company says TNFerade is particularly useful in pancreatic cancer because it is a strong anti-cancer protein to fight a very serious tumor without major side effects for the patients. The drug appears to help control pancreatic cancer and improve survival in those suffering from the hard-to-treat disease, the company claims.
TNFerade is also being evaluated in other cancer indications including esophageal cancer, rectal cancer, and head and neck cancer.
by RTT Staff Writer
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