Oncolytics Biotech Announces Decision to Pursue Phase II/III Pivotal Clinical Trial
News Nov 05, 2008
Oncolytics Biotech Inc. announced that it has made a decision to pursue a pivotal (Phase II/III) randomized trial using the combination of REOLYSIN® with paclitaxel/carboplatin in refractory patients with head and neck cancers. The decision was made following a review of results by the Company's Board of Directors from the Company's ongoing U.K.
Phase I and Phase II combination REOLYSIN® and paclitaxel/carboplatin clinical trials. The results were presented November 1, 2008 at the International Society for Biological Therapy of Cancer (iSBTc) annual meeting in San Diego, CA.
"Eight out of nine head and neck patients reported on to date from the Phase I and Phase II studies had either a partial response or stabilization of disease," said Dr. Brad Thompson, President and CEO of Oncolytics, "This response rate exceeds that of the current standard of care for this patient group, and more than warrants proceeding to a pivotal program."
Oncolytics is currently convening a group of experts in Europe and the U.S. to design a protocol for the Phase II/III trial, which will then be submitted to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMEA) for review. Following FDA and EMEA review, Oncolytics expects to file for approval for this trial early in 2009.