TNFerade(TM) to Continue in Phase II Trial
May 25, 2005 - 8:51:38 PM
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."
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