CALGARY, Nov. 21, 2011 /CNW/ - 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.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase 3 trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's relationship with SAFC and the manufacture of REOLYSIN; belief as to the potential of REOLYSIN as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2011 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.