Targeted enrollment will be expanded from 74 to 330 patients. The expanded phase II/III trial will include additional study sites outside the US. In order to support the expansion, GenVec has entered into a $30 million financing agreement with Kingsbridge Capital Limited.
This trial will now seek to enroll approximately 330 patients with locally advanced pancreatic cancer. 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 recruiting new study sites in the US, India and Israel in addition to the US sites that have been participating in the ongoing phase II trial.
“Expanding the phase II study in this manner will allow us to continue to enroll patients at current clinical sites, avoid the potential delays associated with starting a new trial and facilitate international registration and partnering efforts by including medical centers from outside the US,” said Dr Paul Fischer, GenVec’s president and CEO.