TNFerade(TM) to Continue in Phase II Trial
May 25, 2005 - 8:52:00 PM, Reviewed by: Dr.
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"Our clinical results to date with TNFerade(TM) in a variety of solid tumors, including pancreatic and rectal cancer, have been very encouraging and we look forward to expanding our efforts in rectal cancer."
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By GenVec, Inc.,
GenVec, Inc. (Nasdaq:GNVC) announced today that the U.S. Food and Drug Administration (FDA) informed the company that it may resume its Phase II clinical trial of TNFerade(TM) in rectal cancer. This trial will be conducted in collaboration with the Surgery Branch of the National Cancer Institute to evaluate the use of TNFerade in combination with chemoradiation for rectal cancer to improve complete response rates, surgical outcomes and survival.
The FDA indicated that the clinical hold issues have been satisfactorily addressed for the rectal and esophageal indications and, as such, the clinical hold has been removed from the TNFerade(TM) IND. GenVec will resume the enrollment process for the Phase II rectal study. For the esophageal study, the patient accrual is now completed and closed. Follow-up of the patients in the esophageal study is ongoing.
"We are pleased to resume clinical testing of TNFerade(TM) for the treatment of rectal cancer and greatly appreciate the FDA's efforts to resolve the clinical hold on this program," said Dr. Paul H. Fischer, President and CEO of GenVec. "Our clinical results to date with TNFerade(TM) in a variety of solid tumors, including pancreatic and rectal cancer, have been very encouraging and we look forward to expanding our efforts in rectal cancer." 
- U.S. Food and Drug Administration (FDA)
www.genvec.com
The company will highlight the TNFerade(TM) program during a corporate presentation on Thursday, May 26, 2005 at 1:00 pm ET at the Fourth Annual Needham & Company Biotechnology Conference. The presentation will be webcast live on GenVec's website at www.genvec.com under "Webcasts and Data."
GenVec, Inc. is a clinical stage biopharmaceutical company developing TNFerade(TM) for cancer as well as BIOBYPASS(R) for severe coronary artery disease and AdPEDF for age-related macular degeneration. Additional information on 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 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.
Contacts
GenVec, Inc.
Rena Cohen, 240-632-5501
[email protected]
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