Biotech Values

[bladerunner1717]

re: GNVC

(These results seem rather underwhelming to me, but I'd appreicate comments from people more knowledgeable than I.)



GenVec Announces Interim Survival Data in Pivotal Trial of TNFerade™ in Locally Advanced Pancreatic Cancer
Interim Analysis Supports Continuation of GenVec’s PACT Study

Conference Call Scheduled for Today at 9:00AM

GAITHERSBURG, Md.--(BUSINESS WIRE)-- GenVec, Inc. (Nasdaq:GNVC) announced today top-line results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade™ (PACT) in patients with locally advanced pancreatic cancer. This interim analysis of overall survival, conducted after the 92nd death (one-third of total expected events), was designed to determine whether the study should continue and took place in the time frame originally estimated.

Interim data demonstrated an approximately 25% lower risk of death in the TNFerade plus standard of care (SOC) arm relative to the SOC alone (Hazard Ratio= 0.753; 95% Confidence Interval [0.494-1.15]). An independent Data Safety Monitoring Board reviewed the interim analysis data and recommended the trial continue as planned.

Kaplan-Meier analysis of data, based on this interim analysis, demonstrated that overall survival at 12 months was 39.9% in the TNFerade plus SOC arm versus 22.5% in the SOC arm. Overall survival at 18 months was 30.5% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. At 24 months, overall survival was 10.6% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. Median survival was 9.9 months in both arms of the trial.

“Successfully passing this milestone in the PACT trial represents an important step forward in the clinical development of TNFerade,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. Thornton continued, “We believe these data are encouraging and justify moving forward with the trial. The continuation of the trial will allow the data to mature and provide for future analyses. We currently estimate we will reach the required number of events needed to conduct the next analysis of data in the PACT study in late 2009.”

The next interim analysis will be conducted after 184 deaths have occurred (two-thirds of total expected events) in the PACT trial. “At our current rate of enrollment we also anticipate having enrolled over 300 out of 330 total patients planned for the trial by the end of next year,” added Thornton.



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