Healthcare Industry News: TNFerade
News Release - January 27, 2006
Long-Term Survival Data from Genvec's Phase II Study of TNFerade(TM) in Esophageal Cancer Presented at ASCO GISurvival Profile Compares Favorably with Recent Studies
GAITHERSBURG, Md.--(HSMN NewsFeed)--Jan. 27, 2006--GenVec, Inc. (Nasdaq:GNVC ) announced today that Dr. Neil Senzer, Medical Director of the Mary Crowley Research Center, located in Dallas, Texas, has presented long-term follow-up data on the Phase II study of GenVec's investigational oncology drug, TNFerade, at the American Society of Clinical Oncology's Gastroenterological Cancer Symposium, currently in session in San Francisco. In oral and poster presentations, Dr. Senzer discussed results from a regimen in which 24 patients with locally advanced, resectable esophageal cancer were treated prior to surgery with chemotherapy, radiation, and TNFerade injections to the tumor in doses ranging from 4x10e8 p/u to 4x10e11 p/u.
Esophageal cancer is a difficult to treat disease, and only modest progress has been made in patient survival post-diagnosis during the past decade. After one year, 88% of the Phase II study patients were alive, which compares favorably with the average one-year survival of 52% reported in six comparable recent studies. Seven of the surviving patients have been followed out past 24 months. The two-year survival percentage for all dosage levels of TNFerade combined is currently 73%, with follow-up continuing. The average two-year survival percentage reported in five comparable recent studies was 33%. The median survival point for all patients in GenVec's study has not yet been reached, with follow-up ranging from 16 to 34 months.
"TNFerade has been tested in a wide variety of cancers and continues to show promising indications of activity even in some of the more difficult to treat solid tumors such as esophageal and pancreatic cancer," said Thomas A. Davis, M.D., GenVec's Chief Medical Officer.
GenVec is currently conducting a multi-center Phase II trial with TNFerade in locally advanced pancreatic cancer (the PACT Study), a Phase II trial in rectal cancer in collaboration with the National Cancer Institute, and a Phase II trial in metastatic melanoma.
GenVec, Inc. is a biopharmaceutical company focused on the development of TNFerade for cancer. Additional information on GenVec and its portfolio of product candidates is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission. The ASCO GI poster contains additional information relating to the Phase II esophageal study, including background information, objectives, study design, safety and efficacy results and conclusions. A copy of the poster presentation can be found on GenVec's website by selecting Webcasts & Data/Recent Data Presentations/Esophageal Cancer.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future programs and studies, 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 relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators, risks relating to the commercialization, if any, of GenVec's proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); 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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