CALGARY, Jan. 3 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a
letter of approval from the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical
trial using intravenous administration of REOLYSIN(R) in combination with
docetaxel (Taxotere(R)) in patients with advanced cancers including bladder,
prostate, lung and upper gastro-intestinal. The principal investigator is
Professor Hardev Pandha of The Royal Surrey Hospital, U.K. Docetaxel is used
in patients with lung, breast and prostate cancers, and is also used widely in
the treatment of many other types of cancers.
“The trial is expected to yield data that will further characterize
responses in these target patient populations and will help in designing the
late-stage development program for REOLYSIN(R),” said Dr. Brad Thompson,
President and CEO of Oncolytics.
In preclinical studies conducted at the U.S. National Cancer Institute
(NCI) and Royal Surrey Hospital in the U.K., the combination of REOLYSIN(R)
and various taxanes including docetaxel has been shown to be synergistic
against a variety of cancer cell lines.
The trial (REO 010) has two components. The first is an open-label,
dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with
docetaxel every three weeks. A standard dosage of docetaxel will be delivered
with escalating dosages of REOLYSIN(R) intravenously. A maximum of three
cohorts will be enrolled in the REOLYSIN(R) dose escalation portion. The
second component of the trial will immediately follow and will include the
enrolment of a further 12 patients at the maximum dosage of REOLYSIN(R) in
combination with a standard dosage of docetaxel.
Eligible patients include those who have been diagnosed with advanced or
metastatic solid tumours such as bladder, lung, prostate or upper
gastro-intestinal cancers that are refractory (have not responded) to standard
therapy or for which no curative standard therapy exists. The primary
objective of the trial is to determine the Maximum Tolerated Dose (MTD),
Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety
profile of REOLYSIN(R) when administered in combination with docetaxel.
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.
In the U.K. and the U.S., approximately 600,000 people are diagnosed
annually with bladder, lung, prostate and upper gastro-intestinal cancers.
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
For more information about docetaxel (taxotere(R)) please visit
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. combination REOLYSIN(R)/docetaxel 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
SOURCE Oncolytics Biotech Inc.
Released January 3, 2007