Full Press Release Details
210, 1167 Kensington Cres. NW
Announces Start of Enrolment in U.S. Phase 2
Clinical Trial for Non-Small Cell Lung Cancer Patients with
or EGFR-Activated Tumours
CALGARY, AB, --- March 12,
2009 - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY)
announced today that it has started patient enrolment in a Phase 2 clinical
trial using intravenous administration of REOLYSIN in combination with
paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC)
with K-RAS or EGFR-activated tumours. The Principal Investigator is
Dr. Miguel Villalona-Calero, Professor, Division of Hematology/Oncology and
Department of Internal Medicine and Pharmacology at The Ohio State University
Comprehensive Cancer Center.
quite excited about this trial, since there are no known therapies that to date
have effectively targeted K-RAS in cancer patients," said Dr.
Villalona-Calero. "If this therapy works, this could substantially
impact the outlook for our patients."
trial (REO 016) is a single arm, single-stage, open-label, Phase 2 study of
REOLYSIN given intravenously with paclitaxel and carboplatin every 3
weeks. Patients will receive four to six cycles of paclitaxel and
carboplatin in conjunction with REOLYSIN , at which time REOLYSIN may be
continued as a monotherapy. It is anticipated that up to 36 patients will be
treated in this trial.
patients include those with metastatic or recurrent NSCLC with K-RAS or
EGFR-activated tumours, who have not received chemotherapy treatment for their
metastatic or recurrent disease. Patients must have demonstrated mutations in
K-RAS or EGFR, or EGFR gene amplification in their tumours (metastatic or
primary) in order to qualify for the trial.
Oncolytics Biotech Inc.
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 , 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.S. Phase 2 combination
REOLYSIN /paclitaxel and carboplatin clinical trial for patients with non-small
cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours, and the Company's belief as to the
potential of REOLYSIN 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 as a cancer
treatment, the tolerability of REOLYSIN outside a controlled test, the success
and timely completion of clinical studies and trials, the Company's ability to
successfully commercialize REOLYSIN , 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, except as
required by applicable laws.
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