GenVec Cleared to Resume Phase II Trial in Rectal Cancer with TNFerade

May 25, 2005

The FDA has informed GenVec that it may resume its Phase II clinical trial of TNFerade 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 investigational new drug application.

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.