CALGARY, May 22 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has successfully
transferred cGMP production for REOLYSIN(R) at the 40-litre batch size to SAFC
Pharma(TM), a Division of Sigma-Aldrich Corporation. This follows the
successful scale-up from 20 litres to 40 litres announced by the Company last
year.
Yields at the 40-litre scale should provide sufficient doses to support
future development plans leading to registration and also anticipated early
stage commercial requirements. Development work to support further scale-up to
the 100-litre level is currently underway.
“Manufacturing at a commercial scale is an integral part of our
development plans for REOLYSIN(R),” said Dr. Matt Coffey, Chief Scientific
Officer of Oncolytics. “We have built a solid relationship with SAFC Pharma
through numerous projects ranging from media optimization to scale up efforts,
and we are very pleased to be working with an international leader with a
proven track record in biologic manufacturing.”
“We are very proud to be Oncolytics’ chosen partner for cGMP production of
REOLYSIN(R). Consistent with our previous announcement of a $12 million
expansion of capacity, we will be in a position to support commercial
production of REOLYSIN(R),” said Jeffrey L. Strobel, Ph.D., Site Director at
SAFC Pharma’s Carlsbad operation. The Carlsbad operation of SAFC Pharma
supports the viral vector and vaccine community with its process development
and analytical laboratory expertise, as well as its cGMP capability (cell and
virus banks, bulk virus manufacturing, and formulated, filled, and finished
drug).
About SAFC: SAFC(R) is the custom manufacturing and services group within
Sigma-Aldrich that focuses on high-purity inorganics for high technology
applications, cell culture products and services for biopharmaceutical
manufacturing, biochemical production and the manufacturing of complex,
multi-step organic synthesis of APIs and key intermediates. SAFC has
manufacturing facilities around the world dedicated to providing manufacturing
services for companies requiring a reliable partner to produce their custom
manufactured materials. SAFC has four focus areas – SAFC Pharma, SAFC Supply
Solutions(R), SAFC Biosciences(TM), and SAFC Hitech(TM) – and had annual sales
of nearly $600 million in 2007. SAFC is one of the world’s 10 largest fine
chemical businesses. For more information about SAFC, visit
www.safcglobal.com.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High
Technology company. Its biochemical and organic chemical products and kits are
used in scientific and genomic research, biotechnology, pharmaceutical
development, the diagnosis of disease and as key components in pharmaceutical
and other high technology manufacturing. The Company has customers in life
science companies, university and government institutions, hospitals, and in
industry. Over one million scientists and technologists use its products.
Sigma-Aldrich operates in 36 countries and has 7,900 employees providing
excellent service worldwide. Sigma-Aldrich is committed to Accelerating
Customer Success through Leadership in Life Science, High Technology and
Service. For more information about Sigma-Aldrich, please visit its
award-winning Web site at http://www.sigma-aldrich.com.
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 Phase I/II and Phase II
human trials using REOLYSIN(R), its proprietary formulation of the human
reovirus, alone and in combination with radiation or chemotherapy. 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 expectations related to
the manufacturing process, sufficiency of the 40-litre scale and
commercialization, and the Company’s belief as to the potential of REOLYSIN(R)
as a cancer therapeutic, 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(R) as a cancer treatment, the
success and timely completion of clinical studies and trials, the Company’s
ability to successfully commercialize REOLYSIN(R), uncertainties related to
the research and development of pharmaceuticals and uncertainties related to
the regulatory process. 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.
SOURCE Oncolytics Biotech Inc.
Released May 22, 2008