CALGARY, May 14 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that 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
Phase II 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. Kevin Harrington of The
Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.
“Interim data recently presented from our U.K. Phase I dose escalation
trial of REOLYSIN(R) in combination with paclitaxel and carboplatin indicated
strong and durable responses in patients with advanced head and neck cancers,”
said Dr. Brad Thompson, President and CEO of Oncolytics. “We believe it is
important to further explore these findings by conducting a Phase II trial in
this specific patient population.”
This trial is a 14 patient, single arm, open-label, dose-targeted,
non-randomized, multi-centre trial of REOLYSIN(R) given intravenously in
combination with a standard dosage of paclitaxel and carboplatin. Patients
with a variety of advanced cancers, including head and neck cancers, will
continue to be treated in the ongoing U.K. combination paclitaxel and
carboplatin trial.
Eligible patients include those with advanced or metastatic head and neck
cancer that are refractory to standard therapy or for which no curative
standard therapy exists. The primary objective of the Phase II 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 cancer.
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/II 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.K. Phase II 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 14, 2008