[Not stated in this PR is whether GNVC will disclose the hazard ratio observed at the latest interim analysis, as was done after the first interim analysis, or whether the disclosure to investors will be limited to yes/no on meeting the stringent p-value threshold for success at this point in the trial.]
GAITHERSBURG, Md., Jan. 15 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that 184 events (deaths) have occurred in its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade (PACT) in patients with locally advanced pancreatic cancer. This event, which represents two-thirds of the total events expected in the trial, triggers the next interim analysis of overall survival in the trial. GenVec expects data from this interim analysis to be available in approximately 10-12 weeks.[But what, exactly, will be disclosed to investors?]
"This is another significant milestone for the PACT trial. The data released at the last interim look were encouraging and we are looking forward to the top-line results of the upcoming data analysis," stated Dr. Mark Thornton, GenVec's Senior Vice President of Product Development.
The first interim analysis of overall survival in the PACT trial was released in November 2008. These data demonstrated an approximately 25% lower risk of death[i.e. a hazard ratio of 0.75] in the TNFerade plus standard of care arm relative to standard of care alone. The next and final analysis will be conducted after 276 deaths have occurred (total expected events) in the PACT trial.
About PACT
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.
About TNFerade
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. TNFerade has also received Orphan Product designation by the FDA for treating pancreatic cancer. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade, 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 influenza, 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.‹
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