Oncolytics Biotech Inc. Announces U.K. Phase II Clinical Trial Investigating REOLYSIN(R) in Combination with Paclitaxel and Carboplatin
14/05/2008 08:03
PR Newswire
CALGARY, Canada, May 14 /PRNewswire/ -- 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
http://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.
For further information: Oncolytics Biotech Inc.: Cathy Ward, 210, 1167
Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: +1-403-670-7377, Fax:
+1-403-283-0858, cathy.ward@oncolytics.ca; The Equicom Group: Nick Hurst,
325, 300 5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: +1-403-538-4845, Fax:
+1-403-237-6916, nhurst@equicomgroup.com; The Investor Relations Group: Erika
Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: +1-212-825-3210,
Fax: +1-212-825-3229, emoran@investorrelationsgroup.com
For further information: Oncolytics Biotech Inc.: Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: +1-403-670-7377, Fax: +1-403-283-0858, cathy.ward@oncolytics.ca; The Equicom Group: Nick Hurst, 325, 300 5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: +1-403-538-4845, Fax: +1-403-237-6916, nhurst@equicomgroup.com; The Investor Relations Group: Erika Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: +1-212-825-3210, Fax: +1-212-825-3229, emoran@investorrelationsgroup.com
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