GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq: GNVC) announced today that an independent data safety monitoring board (DSMB) has completed a planned interim analysis of safety data from the ongoing Phase II/III clinical trial with TNFerade™ in locally advanced pancreatic cancer. In addition to its recommendation that the trial continue, the DSMB supported the use of endoscopic ultrasonography (EUS) as an alternative to percutaneous tumor administration. GenVec has provided its interim safety data to the U.S. Food and Drug Administration (FDA) and is waiting for final clearance to move forward with EUS administration.
The Phase II/III clinical trial, known as PACT, is a multi-center, randomized and controlled study of 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care, versus standard of care alone (SOC) in patients with locally advanced 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, M.D., Ph.D., senior vice president of product development for GenVec. “We think it is noteworthy that the DSMB agrees with our conclusion that following receipt of TNFerade + SOC versus SOC in 25 versus 15 patients respectively, there was no statistical difference in the incidence rates of protocol-defined thromboembolic events between the two groups (20% vs. 20%, respectively).” Dr. Thornton added, “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."
The independent Data Safety Monitoring Board (DSMB) established by GenVec, is comprised of medical, surgical and statistical experts in pancreatic cancer and is responsible for monitoring the patients participating in the Phase II/III clinical trial and conducting periodic analyses of drug safety and efficacy. The board operates under a written charter, consistent with good clinical practice guidelines.
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFα), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Additional information about GenVec and its portfolio of product candidates is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.
source - Business Wire