CALGARY, April 2, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) announced today that it has completed enrollment
in the first, 80 patient stage of its Phase III clinical trial
examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with
platinum-refractory head and neck cancers (REO 018).
“This is an important milestone for this study,” said Dr. Brad Thompson,
President and CEO of Oncolytics. “A data analysis that will involve
examining evolving progression free survival will now be performed on
this patient group to determine the probability of success in the
second stage of the study.”
The randomized, two-arm, double-blind, multi-centre, two-stage, adaptive
Phase III trial will assess the intravenous administration of REOLYSIN
with the chemotherapy combination of paclitaxel and carboplatin versus
the chemotherapy alone in patients with metastatic or recurrent
squamous cell carcinoma of the head and neck, or squamous cell cancer
of the nasopharynx, who have progressed on or after prior
platinum-based chemotherapy. All patients will receive treatment every
three weeks (21 day cycles) with paclitaxel and carboplatin and will
also receive, on a blinded basis, either intravenous placebo or
intravenous REOLYSIN. All dosing takes place in the first five days of
each cycle, with all patients receiving standard intravenous doses of
paclitaxel and carboplatin on day one only, and on days one through
five, either intravenous placebo or intravenous REOLYSIN at a dose of
3×1010 TCID50. Patients may continue to receive the trial combination therapy for up
to eight, 21-day cycles and, thereafter, blinded placebo or blinded
REOLYSIN until the patient has progressive disease or meets other
criteria for removal from the trial.
The primary endpoint for the trial is overall survival (OS). Secondary
endpoints include progression free survival (PFS), objective response
rate (complete response (CR) + partial response (PR)) and duration of
response, and safety and tolerability of REOLYSIN when administered in
combination with paclitaxel and carboplatin. The first stage of the
trial is non-adaptive, and was designed to enroll 80 patients. The
second stage is adaptive, and is designed to enroll between 100 and 400
patients with the most probable statistical enrollment being 195
patients in this stage. This adaptive trial design allows data
evaluation to determine if the probability of reaching a statistically
significant endpoint has been achieved.
The trial is currently being conducted in more than 80 centres in 12
countries in North America and Europe, including the U.S. following an
agreement with the U.S. Food and Drug Administration (FDA) under the
Special Protocol Assessment (SPA) process with respect to the trial’s
design.
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 human trials
including a Phase III trial in head and neck cancers using REOLYSIN,
its proprietary formulation of the human reovirus. 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 Phase III head and neck cancers 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 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.
SOURCE Oncolytics Biotech Inc.
Released April 2, 2012