GENVEC EXPANDS TNFERADE PANCREATIC CANCER STUDY
GenVec has received clearance from the FDA to expand its current Phase II clinical trial with TNFerade in locally advanced pancreatic cancer into a Phase II/III trial with a 12-month survival endpoint. Targeted enrollment will be expanded from 74 to 330 patients. The expanded Phase II/III trial will include additional study sites outside the U.S.
Patients will be randomized two-to-one to receive chemotherapy (fluorouracil) and radiation therapy for five weeks, with or without a weekly intratumoral injection of TNFerade, followed by maintenance therapy (gemcitabine with or without Tarceva). The primary endpoint of the study will be overall survival at 12 months. GenVec is actively recruiting new study sites in the U.S., India and Israel in addition to the U.S. sites that have been participating in the ongoing Phase II trial.