GAITHERSBURG, Md., June 1 /PRNewswire-FirstCall/ -- Overall survival data in locally advanced pancreatic cancer patients treated with TNFerade(TM) in GenVec's ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade(TM) (PACT) were presented yesterday at the 45th American Society of Clinical Oncology Annual Meeting in Orlando, FL.
The poster, entitled "Multi-Center Randomized Controlled Phase III Clinical Trial using TNFerade(TM) with Chemoradiation in Patients with Locally Advanced Pancreatic Cancer: Interim Analysis of Overall Survival," reported on results of an interim analysis from the PACT trial. This interim analysis of overall survival was conducted after the 92nd death (one-third of total expected events) had occurred.
The analysis concluded that TNFerade appeared to be safe and well-tolerated. The analysis also indicated a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone (Hazard Ratio = 0.75; 95% Confidence Interval [0.494 - 1.15]).
Dr. Mark Thornton, GenVec's Senior Vice President of Product Development commented on the poster, noting, "In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. Although the data still need time and events to reach maturity, we are encouraged by the survival trend being observed at this point in the trial."
This poster can be accessed online by visiting www.genvec.com and clicking on "Investor Relations" then "Webcasts & Data" then "Data Presentations."
GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.
TNFerade, which has not yet been approved for use, is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF alpha), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF alpha in the tumor. TNFerade has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade(TM), is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.
|SOURCE GenVec, Inc.|
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