SAFC commences process validation activities for Oncolytics' REOLYSIN

Nov 21 2011

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced that SAFC, a Division of Sigma-Aldrich Corporation, has commenced validation activities designed to demonstrate the manufacturing process for the commercial production of REOLYSIN^®, Oncolytics' proprietary formulation of reovirus, is robust and reproducible. Process validation is required to ensure that the resulting product meets required specifications and quality standards and will form part of the Company's submission to regulators, including the US Food and Drug Administration (FDA), for product approval.

"Process validation is a critical piece of the commercialization process for REOLYSIN assuming our clinical studies are ultimately successful," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We have worked diligently to advance our manufacturing program in parallel with our clinical efforts to ensure we have sufficient quantities for both late-stage clinical testing and commercial launch."

Oncolytics' broad clinical program currently has more than 10 trials enrolling patients including a Phase III study in head and neck cancer using a protocol agreed by the FDA under the Special Protocol Assessment process, and randomized Phase II studies in ovarian and metastatic pancreatic cancers.