Oncolytics Announces Independent Data Monitoring Committee Recommends Continued Enrollment in Phase III Study of REOLYSIN(R) in Head and Neck Cancers Following Review of Safety Data
CALGARY, June 20, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX: ONC) NASDAQ: ONCY) announced today that the Company’s independent
Data Monitoring Committee (DMC) has reviewed the safety data for the
first stage of its Phase III trial of REOLYSIN in combination with
carboplatin and paclitaxel for the treatment of head and neck cancers
(REO 018). Based on the review of the safety data the DMC has
recommended that enrollment continue in the study.
“The safety data from the first stage of the Phase III study met our
expectations and confirms the positive safety data from our other
clinical studies using REOLYSIN,” said Dr. Brad Thompson, President and
CEO of Oncolytics. “We will now focus our time and attention on
conducting the statistical analysis of the efficacy of the first
stage’s patient population, which is forthcoming.”
The study design stipulates that the study will proceed to full
enrollment in Stage 2 (ranging from 100 to 400 additional patients)
provided that the DMC concludes that safety data in Stage 1 is
acceptable for continuation to Stage 2, and an independent statistical
analysis of Progression-Free Survival (PFS, a measure of efficacy) in
Stage 1 predicts probability of success in Stage 2. The data collection
for this analysis is currently being performed.
The safety analysis was performed on the 80 patients enrolled in Stage 1
of the study, once every patient had sufficient follow up after
starting treatment on the study (six weeks). The statistical analysis
will be performed once every patient has had sufficient follow up after
starting treatment (12 weeks) to determine potential differences in PFS
between the control and test arms of the study.
The study is a randomized, two-arm, double-blind, multi-centre,
two-stage, adaptive Phase III trial assessing 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. On April 2, 2012, the
Company announced that enrollment in the non-adaptive, 80-patient first
stage of the trial had been completed. Enrollment is currently underway
in the adaptive second stage, which is designed to enroll between 100
and 400 patients. This adaptive trial design allows data evolution to
determine if the probably of reaching a statically significant endpoint
has been achieved. The trial is currently being conducted at more than
80 centres in 14 countries in North America and Europe, including the
United States 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
SOURCE Oncolytics Biotech Inc.