CALGARY, March 25 /CNW/ - 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(R) in combination with gemcitabine (Gemzar(R)) 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, Scotland.
A total 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%.
"The 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/m(2)) 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, (CTRC at UTHSCSA)."
The U.K. trial (REO 009) is an open-label, dose-escalating,
non-randomized study of REOLYSIN given intravenously with gemcitabine every
three weeks. Gemcitabine (1000 mg/m(2)) was administered to patients in
combination with escalating dosages of REOLYSIN intravenously.
Eligible 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 exists.
The 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 activity.
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, 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
Gemzar(R) is indicated for NSCLC, breast, pancreatic and ovarian cancer.
For more information about Gemzar(R), please visit www.gemzar.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 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.
For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167
Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403)
283-0858, email@example.com; The Equicom Group, Nick Hurst, 325, 300
5th Ave. SW, Calgary, AB, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916,
firstname.lastname@example.org; The Investor Relations Group, Erika Moran, 11 Stone
St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212) 825-3229,