CALGARY, June 27 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ: ONCY) announced today that patient enrolment has commenced in its U.S.
Phase II trial to evaluate the intravenous administration of REOLYSIN(R) in
patients with various sarcomas that have metastasized to the lung. Patients
are being enrolled at the Montefiore Medical Center/Albert Einstein College of
Medicine in the Bronx, New York, the University of Michigan Comprehensive
Cancer Center in Ann Arbor, and the Cancer Therapy and Research Center,
Institute for Drug Development in San Antonio, Texas.
"The initiation of this trial represents an important milestone for the
Company," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are now
treating patients with advanced cancers in Phase II clinical trials in the
U.S. and the U.K., with additional Phase II trials expected to begin before
the end of the year. These trials are expected to yield information that will
guide the late stage clinical development program for REOLYSIN(R)."
The trial (REO 014) is a Phase II, open-label, single agent study whose
primary objective is to measure tumour responses and duration of response, and
to describe any evidence of antitumour activity of intravenous, multiple dose
REOLYSIN(R) in patients with bone and soft tissue sarcomas metastatic to the
lung. REOLYSIN(R) will be given intravenously to patients at a dose of
3x10(10) TCID(50) for five consecutive days. Patients may receive additional
five-day cycles of therapy every four weeks for a maximum of eight cycles. Up
to 52 patients will be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to
the lung deemed by their physician to be unresponsive to or untreatable by
standard therapies. These include patients with osteosarcoma, Ewing sarcoma
family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma
"There are very few treatment options for patients with bone or soft
tissue sarcomas," said Dr. Matt Coffey, Oncolytics' Chief Scientific Officer.
"Our decision to choose this indication is based on the observed activity of
REOLYSIN(R) against sarcomas in both preclinical and clinical studies."
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
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.S. Phase II sarcoma 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 statements.
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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