CALGARY, June 11 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ: ONCY) has commenced patient enrolment in its U.K. clinical trial to
evaluate the anti-tumour effects of systemic administration of REOLYSIN(R) in
combination with gemcitabine (Gemzar(R)) in patients with advanced cancers
including pancreatic, lung and ovarian. The combination of reovirus and
gemcitabine has been shown in preclinical studies to be more effective than
gemcitabine or reovirus alone at killing certain cancer cell lines.
"Exciting preclinical work conducted in collaboration with Cornell
University in New York provided the rationale for this human trial," said
Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "The data gathered in
this trial and in our other ongoing trials in the U.K. and the U.S. is
expected to further define the optimal path to product registration."
The principal investigators are Dr. Johann de Bono of The Royal Marsden
NHS Foundation Trust and The Institute of Cancer Research, London, and
Professor Jeff Evans of the University of Glasgow and the Beatson Oncology
Centre in Glasgow, Scotland.
The trial (REO 009) has two components. The first is an open-label,
dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with
gemcitabine every three weeks. A standard dosage of gemcitabine will be
delivered with escalating dosages of REOLYSIN(R) intravenously. A maximum of
three cohorts will be enrolled in the REOLYSIN(R) dose escalation portion. The
second component of the trial will immediately follow and will include the
enrolment of a further 12 patients at the maximum dosage of REOLYSIN(R) in
combination with a standard dosage of gemcitabine. This trial is one of three
expected to begin in 2007 that will examine the role of REOLYSIN(R) in
combination with standard chemotherapeutics.
Eligible patients include those who have been diagnosed with advanced or
metastatic solid tumours such as pancreatic, lung and ovarian cancers that are
refractory (have not responded) to standard therapy or for which no curative
standard therapy exists. The primary objective of the trial is to determine
the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended
dose and dosing schedule and safety profile of REOLYSIN(R) when administered
in combination with gemcitabine. Secondary objectives include the evaluation
of immune response to the drug combination, the body's response to the drug
combination compared to chemotherapy alone and any evidence of anti-tumour
In the U.K. and the U.S., approximately 280,000 people are diagnosed
annually with pancreatic, lung and ovarian 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 Phase I 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
For more information about gemcitabine (Gemzar(R)) please visit
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 U.K. combination REOLYSIN(R)/gemcitabine clinical trial 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 tolerability
of REOLYSIN(R) outside a controlled test, 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
For further information:
For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167
Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403)
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5th Ave. SW, Calgary, AB, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916,
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