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Oncolytics Biotech Inc. Commences Patient Enrolment in U.S. Phase II Sarcoma Clinical Trial
CALGARY, Canada, June 27 /PRNewswire/ -- 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 meta static 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 and leiomyosarcoma.
"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.






