Healthcare Industry News: TNFerade
News Release - November 11, 2008
TNFerade(TM) Receives FDA Fast Track Designation for Treatment of Pancreatic CancerDesignation Represents a Significant Regulatory Achievement for TNFerade(TM)
GAITHERSBURG, Md.--(HSMN NewsFeed)--GenVec, Inc. (Nasdaq:GNVC ) announced today that 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. The designation is based on GenVec having “provided evidence of the potential to improve survival in patients with pancreatic cancer.”
Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast track designation does not apply to a product alone but to a combination of a product and specific indication. This designation provides for expedited regulatory review. Should events warrant, GenVec will be eligible to submit a U.S. biologics license application (BLA) for TNFerade on a rolling basis. Under certain conditions, this permits the FDA to review sections of the BLA prior to receiving the complete submission.
“This Fast Track designation is an important step in the increasing focus on the clinical potential of TNFerade as a treatment for locally advanced pancreatic cancer,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. “As further data emerge regarding TNFerade, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade.”
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFa in the tumor. 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 candidate, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer and is being evaluated in additional clinical trials in other tumor types. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including foot-and-mouth disease, malaria, HIV, respiratory syncytial virus (RSV), HSV-2, and influenza. 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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