The analysis was conducted by an independent data safety monitoring board (DSMB). In addition to its recommendation that the trial continue, the DSMB supported the use of endoscopic ultrasonography. GenVec has provided its interim safety data to the FDA and is waiting for final clearance.
The phase II/III trial is designed to evaluate the safety and efficacy of TNFerade plus standard of care, versus standard of care alone in patients with pancreatic cancer. This interim evaluation was based on data from 40 patients, 25 of whom received standard of care plus TNFerade.
“We are pleased to receive a positive recommendation from the DSMB in this first-ever review of comparative safety data for TNFerade,” said Mark Thornton, senior vice president of product development for GenVec.
“The DSMB supports expansion of the routes by which patients can receive TNFerade, and we believe administration of TNFerade through endoscopic ultrasonography should accelerate enrollment of eligible patients and attract additional clinical sites,” Dr Thornton added.