Healthcare Industry News: TNFerade
News Release - March 29, 2006
GenVec Begins Phase II Melanoma Study with TNFerade(TM)GAITHERSBURG, Md.--(HSMN NewsFeed)--March 29, 2006--GenVec, Inc. (Nasdaq:GNVC ) has begun a Phase II clinical study to evaluate the anticancer activity of TNFerade(TM) in patients with metastatic melanoma. The open-label, single-arm, multi-center study will assess tumor response after four weeks of intratumoral injections of TNFerade(TM) plus concomitant radiation therapy in 29 patients with stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options. Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.
"This study expands the TNFerade(TM) development program into a potential indication where there is a significant medical need," said Thomas Davis, M.D., chief medical officer of GenVec. "This is an important study as it also provides a good clinical setting for us to test whether TNFerade(TM) can induce the body's immune system to fight systemic cancer."
In a Phase I trial in patients with solid tumors, three patients with stage IV metastatic melanoma had complete local response and prolonged disease-free survival after local TNFerade(TM) lesion injection plus concomitant radiation; two of those patients remain disease-free approximately four years after treatment. This compares to the average survival rate of less than 2 years for patients with stage IV metastatic melanoma. Previous studies have demonstrated the ability of TNFerade(TM) to suppress the metastasis of melanoma into the lymph nodes in an animal model (see GenVec press release dated April 20, 2005). GenVec recently announced the expansion of its ongoing Phase II study of TNFerade(TM) in patients with locally advanced pancreatic cancer into a 330 patient Phase II/III clinical trial.
TNFerade(TM) 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(TM) stimulates the production of TNF-alpha in the tumor. GenVec is developing TNFerade(TM) for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. 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.
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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