CALGARY, May 29 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) has commenced patient enrolment in its
U.K. clinical trial to evaluate the anti-tumour effects of systemic
administration of REOLYSIN(R) in combination with paclitaxel and carboplatin
in patients with advanced cancers including head and neck, melanoma, lung and
ovarian. This trial is one of three expected to begin in 2007 that will
examine the role of REOLYSIN(R) in combination with standard
chemotherapeutics.
“This study is the first to examine the use of REOLYSIN(R) with drug
combinations that are used in first or second line therapy,” said Dr. Matt
Coffey, Chief Scientific Officer for Oncolytics. “Our collaborators have shown
in preclinical studies that the activity of these agents is dramatically
enhanced by the addition of REOLYSIN(R) and we are pleased to be examining
this combination in patients.”
The principal investigators are Dr. Kevin Harrington of The Institute of
Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall
of St. James’s Hospital in Leeds, U.K.
The trial (REO 011) has two components. The first is an open-label,
dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with
paclitaxel and carboplatin every three weeks. Standard dosages of paclitaxel
and carboplatin 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 paclitaxel and
carboplatin.
Eligible patients include those who have been diagnosed with advanced or
metastatic solid tumours such as head and neck, melanoma, 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
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 paclitaxel and carboplatin. 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 350,000 people are diagnosed
annually with head & neck, melanoma, lung and ovarian 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 paclitaxel and carboplatin, please visit
www.bms.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. combination REOLYSIN(R)/paclitaxel and carboplatin 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.
SOURCE Oncolytics Biotech Inc.
Released May 29, 2007