In October 2004, the FDA placed the TNFerade clinical program on hold after blood clots were observed in patients with esophageal cancer in a separate phase II trial. In February, GenVec was granted permission to move forward with the pancreatic cancer study but studies in esophageal and rectal cancer remained on clinical hold.
The phase II rectal cancer trial will now proceed, however, and will be conducted in collaboration with the Surgery Branch of the National Cancer Institute to evaluate the use of TNFerade in combination with chemoradiation 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.
For the esophageal study, the patient accrual is now completed and closed. Follow-up of the patients in the esophageal study is ongoing.