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FDA Halts TNFerade Clinical Trials

GAITHERSBURG, Md., Oct. 7 /PRNewswire-FirstCall/ -- GenVec (Nasdaq: GNVC) today announced that the U.S. Food and Drug Administration (FDA) has requested that clinical trials of TNFerade be placed on clinical hold, pending review of information pertaining to a potential increase in the incidence of blood clots in patients with esophageal cancer who received the highest dose of TNFerade in a Phase 2 clinical trial. Interim results from this dose-escalation trial were reported by GenVec and presented at the European Organization for Research and Treatment of Cancer (EORTC) meeting in Geneva, Switzerland on October 1, 2004. GenVec will be providing additional data to the FDA over the next several days and expects to receive a letter from the agency confirming the clinical hold and providing details of the follow up actions needed before the company can resume clinical trials. TNFerade is currently in Phase 2 clinical studies for locally advanced pancreatic, esophageal, and rectal cancer.

"Our patients' safety is very important to us. We are responding quickly to the FDA and look forward to addressing their questions, and will provide an update on the status of our discussions as soon as more substantive information is available," said Paul H. Fischer, Ph.D., GenVec's President and CEO.

Source: GenVec

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