CALGARY, March 20 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ:
ONCY) announced that interim clinical results from its Phase I/II U.K. trial
of REOLYSIN(R) combined with paclitaxel/carboplatin for patients with advanced
cancers were presented at the Fifth International Meeting on Replicating
Oncolytic Virus Therapeutics. The meeting is being held in Banff, Alberta from
March 18th to 22nd, 2009. The principal investigator for the trial is Dr.
Kevin Harrington of The Institute of Cancer Research.
To date, fifteen head and neck cancer patients have been treated in the
Phase I/II trial (REO 011). All but one patient had prior platinum treatment.
Of 12 patients evaluable for clinical response, five have experienced Partial
Response (PR) and four have experienced Stable Disease (SD) ranging from two
to six months. For patients who have been followed for at least six months
since their initial treatment, the median progression-free survival (PFS) is
currently six months, while the overall survival is currently seven months.
The literature suggests that platinum refractory patients typically have a PFS
of approximately two months and a median survival ranging from 4.5 to 6.5
months. The overall survival figure may evolve as many of the patients are
still alive.
"In patients previously treated with platinum agents, where the response
rate (PR and Complete Response (CR)) is generally in the 3-10% range, a
response rate of 42% and a 75% clinical benefit rate (SD, PR, and CR) are
dramatic," said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics.
The Phase I/II trial has two components. The first is a Phase I,
open-label, dose-escalating, non-randomized study of REOLYSIN(R) given
intravenously in combination with paclitaxel and carboplatin every three
weeks. In this portion of the trial, standard dosages of paclitaxel and
carboplatin are delivered to patients with escalating intravenous dosages of
REOLYSIN(R). Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours such as head and neck, melanoma, lung and
ovarian that are refractory (have not responded) to standard therapy or for
which no curative standard therapy exists. The second component of the trial
is a Phase II, 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.
An independent, confirmatory Phase II trial using the same combination of
REOLYSIN(R) and carboplatin/paclitaxel for patients with head and neck cancers
is currently underway in the U.S. Interim results from both the U.K. and the
U.S. study formed the basis of the Phase III pivotal program now being
developed for REOLYSIN(R) in combination with carboplatin/paclitaxel in this
patient population.
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 implication of the materials
presented at this meeting with respect to REOLYSIN(R), the Company's
expectations related to the results of trials investigating delivery of
REOLYSIN(R), the Company's analysis of the results of the Phase I/II
REOLYSIN(R) paclitaxel and carboplatin 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 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, uncertainties related to the regulatory
process and general changes to the economic environment. 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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For further information: Oncolytics Biotech Inc.: Cathy Ward, 210, 1167
Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403)
283-0858, cathy.ward@oncolytics.ca; The Equicom Group: Nick Hurst, 325, 300
5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: (403) 538-4845, Fax: (403)
237-6916, nhurst@equicomgroup.com; The Investor Relations Group: Erika Moran,
11 Stone St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212)
825-3229, emoran@investorrelationsgroup.com
