CALGARY, June 20 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food
and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2
clinical trial using intravenous administration of REOLYSIN(R) in combination
with paclitaxel and carboplatin in patients with advanced head and neck
cancers. The Principal Investigator is Dr. Monica Mita of the Cancer Therapy
and Research Center, University of Texas Health Science Center in San Antonio,
Texas (CTRC at UTHSCSA).
“REOLYSIN(R) is one of the more exciting targeted agents under development
in oncology,” said Dr. Frank Giles, Director of the Institute for Drug
Development. “Our investigators within the CTRC at UTHSCSA are very excited to
begin studying potential synergy with standard cytotoxic agents and are eager
to expand our studies into other tumor types and utilizing other chemotherapy
partner regimens.”
This trial is a 14-patient, single arm, open-label, dose-targeted,
non-randomized trial of REOLYSIN(R) given intravenously in combination with a
standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck
cancers that are refractory to standard therapy or for which no curative
standard therapy exists. The primary objective of the Phase 2 trial is to
measure tumour responses and duration of response, and to describe any
evidence of antitumour activity. The secondary objective is to determine the
safety and tolerability of REOLYSIN(R) when administered in combination with
paclitaxel and carboplatin to patients with advanced or metastatic head and
neck 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 1/2 and Phase 2 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
The Cancer Therapy & Research Center (CTRC) at The University of Texas
Health Science Center at San Antonio is among the nation’s leading academic
research and treatment centers, serving more than 4.4 million people in the
high-growth corridor of Central and South Texas including Austin, San Antonio,
Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in
the country to be named a National Cancer Institute (NCI) Designated Cancer
Center, and is one of only three in Texas. CTRC handles more than 120,000
patient visits each year and is a world leader in developing new drugs to
treat cancer. The CTRC Institute for Drug Development (IDD) is internationally
recognized for conducting the largest oncology Phase I clinical drug trials
program in the world, and participated in the clinical and/or preclinical
development of many of the cancer drugs approved by the U.S. Food & Drug
Administration. For more information, visit our Web site at
www.ctrc.uthscsa.edu.
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 2 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 June 20, 2008