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.
SOURCE Oncolytics Biotech Inc.
For further information:
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