Full Press Release Details
Oncolytics Biotech Inc. Collaborators Present Positive Head and Neck Results in Phase I/II Combination REOLYSIN and Paclitaxel/Carboplatin Trial
CALGARY, AB, --- March 20,
2009 -Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that
interim clinical results from its Phase I/II U.K. trial of REOLYSIN 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.
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
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.
I/II trial has two components. The first is a Phase I, open-label,
dose-escalating, non-randomized study of REOLYSIN 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 . 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 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.
independent, confirmatory Phase II trial using the same combination of REOLYSIN
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 in combination with carboplatin/paclitaxel in this patient
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.
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 , the Company's expectations related to the results of
trials investigating delivery of REOLYSIN , the Company's analysis of the
results of the Phase I/II REOLYSIN paclitaxel and carboplatin trial 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 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, 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
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