CALGARY, June 5 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ: ONCY) announced today positive results from its U.S. Phase I clinical
trial examining the systemic administration of REOLYSIN(R) in patients with
advanced cancers. The results indicate that REOLYSIN(R) can be delivered
systemically to patients with advanced and metastatic cancers and cause
"REOLYSIN(R) administered as a one-hour infusion on a monthly schedule is
safe and well-tolerated even in multiple doses," said Principal Investigator
Dr. Sanjay Goel of the Montefiore Medical Center and Albert Einstein College
of Medicine, New York. "This preliminary data suggests there is anti-tumour
activity of REOLYSIN(R) administered as a single agent, and warrants further
studies either alone or in combination with cytotoxic chemotherapy, which are
currently being planned."
A total of 18 patients were treated in the escalating dosage trial to a
maximum daily dose of 3x10(10) TCID(50) in a one-hour infusion. Of the 18
patients treated, eight demonstrated stable disease as measured by RECIST
(Response Evaluation Criteria in Solid Tumours) including a patient with
progressive breast cancer who experienced a 28.5% shrinkage in tumour volume.
The trial was originally designed to demonstrate the safety of a single,
one-hour infusion of REOLYSIN(R). During the treatment of the 4th cohort of
patients however, Oncolytics applied for and was granted approval to allow
subsequent patients to receive repeat monthly treatments of REOLYSIN(R). Of
the patients eligible for retreatment, three patients received a range of two
to seven one-hour infusions of REOLYSIN(R).
Toxicities possibly related to REOLYSIN(R) treatment in this trial were
generally mild (grade 1 or 2) and included chills, fever and fatigue.
The primary objective of the Company's U.S. Phase I trial is to determine
the maximum tolerated dose, (MTD), dose limiting toxicity (DLT), and safety
profile of REOLYSIN(R) when administered systemically to patients. A secondary
objective is to examine any evidence of anti-tumour activity. Eligible
patients included those who had been diagnosed with advanced or metastatic
solid tumours that are refractory (have not responded) to standard therapy or
for which no curative standard therapy exists.
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 results of the Phase I US Systemic Administration clinical trial
investigating delivery of REOLYSIN(R) for advanced cancers, 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 success and
timely completion of clinical studies and trials, actual patient tolerance,
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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