Full Press Release Details
Biotech Inc. Completes Enrolment in
REOLYSIN /Gemcitabine Trial
CALGARY, AB, --- March 25, 2009 - Oncolytics Biotech Inc.
("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced the completion
of patient enrolment in its U.K. clinical trial to evaluate the anti-tumour
effects of intravenous administration of REOLYSIN in combination with
gemcitabine (Gemzar ) in patients with advanced cancers including breast, and
head and neck. The principal investigators are Dr. Johann de Bono of
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research,
U.K., and Professor Jeff Evans of the University of Glasgow,
of 15 patients were enrolled in the trial. Of the ten patients
evaluable for response, two patients (breast and nasopharyngeal) had partial
responses (PRs) and five patients had SD (stable disease) for 4-8 cycles, for a
total disease control rate (CR (Complete response)+PR +SD) of 70%.
results to date using this treatment combination in late-stage cancer patients
indicate that further studies using this drug combination are warranted," said
Dr. Brad Thompson, President and CEO of Oncolytics. "We plan to initiate further
studies in the U.S. using a modified dosage regime of REOLYSIN and the commonly
used U.S. dosage of gemcitabine (800 mg/m2) in patients with advanced or
metastatic pancreatic cancer in partnership with the Cancer Therapy &
Research Center at The University of Texas Health Science Center in San Antonio,
trial (REO 009) is an open-label, dose-escalating, non-randomized study of
REOLYSIN given intravenously with gemcitabine every three
weeks. Gemcitabine (1000 mg/m2) was administered to patients in
combination with escalating dosages of REOLYSIN intravenously.
patients included those who had been diagnosed with advanced or metastatic solid
tumours including pancreatic, lung and ovarian cancers that are refractory (have
not responded) to standard therapy or for which no curative standard therapy
primary objective of the trial was to determine the Maximum Tolerated Dose
(MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and
safety profile of REOLYSIN 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
Oncolytics Biotech Inc.
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, 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
indicated for NSCLC, breast, pancreatic and ovarian cancer. For more
information about Gemzar , please
visit www.gemzar.com.
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. and U.S.
combination REOLYSIN/gemcitabine clinical trials and the Company's belief as to
the potential of REOLYSIN 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 as a cancer
treatment, the tolerability of REOLYSIN outside a controlled test, 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 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, except as
required by applicable laws.
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