Biotech Values

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GNVC - protocol change.

I would appreciate any thoughts from the statistically inclined who inhabit the board on the implications of these changes for TNFerade's ultimate chance of approval.

GenVec Announces Protocol Changes for PACT Study After Discussions with FDA
Thursday January 3, 7:30 am ET
Regulatory Path for TNFerade(TM) Now Clearly Defined


GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq:GNVC - News) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) to implement the following changes to the company’s Phase 2/3 pancreatic cancer clinical trial (PACT study) with TNFerade™ in patients with locally advanced pancreatic cancer:
Measure overall survival as the primary efficacy endpoint, rather than 12-month survival. No increase in study size will be required, and a benefit in overall survival can be considered as a basis for full regulatory approval of TNFerade for this indication;
Conduct two additional interim analyses of overall survival following one-third (92) and two-thirds (184) of the total events (deaths) for the study, with the potential to stop the trial if there is clear evidence of the drug’s efficacy. The two interim analyses will be performed with minimal statistical penalties of 0.001 and 0.004, respectively.
Dr. Mark Thornton, GenVec’s senior vice president of product development, stated: “We greatly appreciate the FDA’s assistance in developing these protocol changes which will allow us to evaluate TNFerade’s potential efficacy by using the standard and well-accepted measure of overall survival. The next interim analysis, which we anticipate to occur in the fourth quarter of 2008, will be a substantially more robust analysis of overall survival data in terms of number of patients and follow-up period compared to data presented at ASCO last year. With these protocol changes, we believe we now have a clear understanding of the requirements for obtaining regulatory approval of TNFerade.”

The PACT trial, a multi-center randomized and controlled trial, is designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in 330 subjects with locally advanced pancreatic cancer. Chemotherapy and radiation are the current standard-of-care for treating this patient population. Patients in the trial are randomized in a 2:1 ratio to TNFerade plus standard therapy, or standard therapy alone.