GenVec Gets FDA Clearance for Study of TNFerade in Pancreatic Cancer

GenVec has received a letter from the FDA that allows the company to proceed with the randomized, controlled portion of the Phase II clinical trial of TNFerade in patients with locally advanced pancreatic cancer.

This clinical study is designed to assess the clinical benefit of using TNFerade in combination with standard-of-care treatment in patients with this disease.

In October 2004, the FDA placed the TNFerade clinical program on hold due to blood clots seen in patients with esophageal cancer in a separate Phase II trial. In response, GenVec submitted data to the FDA and requested permission to move forward only with the pancreatic cancer study. Other indications that were affected (esophageal and rectal cancer) remain on clinical hold.

The 74-patient randomized, controlled portion of the Phase II study will assess the activity of TNFerade when administered concurrently with 5- flourouracil (5-FU) plus radiation followed by Gemcitabine, versus 5-FU plus radiation followed by Gemcitabine. Outcome measures will include progression-free survival at three months post-treatment, median survival, tumor resectability post-treatment and objective tumor response.