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news.GenVec has received FDA clearance to proceed with the randomized portion of the phase II clinical trial of TNFerade in locally advanced pancreatic cancer, after the program was put on hold last year.
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The study is designed to assess the clinical benefit of using TNFerade in combination with the standard of care treatment.
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 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 (Eli Lilly’s Gemzar), versus 5-FU plus radiation followed by gemcitabine. Outcome measures will include progression-free survival, median survival, tumor resectability and objective tumor response.
Results of the dose-escalation portion of this study of TNFerade in patients with pancreatic cancer showed the dose for the upcoming randomized trial to be generally well-tolerated.
“We are very pleased to resume clinical testing of TNFerade in patients with pancreatic cancer and look forward to enrolling patients in this phase of the study as quickly as possible,” said Dr Paul Kessler, GenVec’s executive director of clinical research. “In the meantime, we will work closely with the FDA to chart a course for the potential clinical development of other promising indications for TNFerade.”
GenVec clinical investigators have been evaluating TNFerade in combination with radiation and chemotherapy for the treatment of various cancers.