FDA Grants Orphan Drug Designation for TNFerade
Wed, 11/04/2009 - 3:27am
GenVec, Inc. announced today that the U.S. Food and Drug Administration (FDA) hasgranted orphan drug designation to TNFerade for the treatment ofpancreatic cancer. The FDA grants orphan drug designation to drugs that may provide asignificant therapeutic advantage over existing treatments and targetconditions affecting 200,000 or fewer U.S. patients per year. Orphan drugdesignation provides potential financial and regulatory incentives includingstudy design assistance, waiver of FDA user fees, tax credits, and up to sevenyears of market exclusivity upon marketing approval. "Orphan drug designation is a critical step for the development ofTNFerade and will strengthen the TNFerade program at GenVec by offeringpotential clinical development and commercialization benefits," stated Dr.Paul Fischer, GenVec's President and CEO. TNFerade, which has not yet been approved for use, is an adenovector, orDNA carrier, which contains the gene for tumor necrosis factor-alpha(TNF-alpha), an immune system protein with potent and well-documentedanti-cancer effects, for direct injection into tumors. After administration,TNFerade stimulates the production of TNF-alpha in the tumor. TNFerade hasbeen granted Fast Track product designation by the U.S. Food and DrugAdministration (FDA) for its proposed use in the treatment of locally advancedpancreatic cancer.