GAITHERSBURG, Md., Jan. 15 GenVec, Inc. (Nasdaq: GNVC) announced today that 184 events (deaths) have occurred in its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade(TM) (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.
"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 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.
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.
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.
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 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.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
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SOURCE GenVec, Inc.