Full Press Release Details
Biotech Inc. Receives
Approval from the U.K. MHRA to Conduct Phase 3 Trial for REOLYSIN in
Head and Neck Cancers
to Host Clinical Update Conference Call--
CALGARY, AB, --- February 16,
2010 - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY)
today announced that it has received a letter of approval from the U.K.
Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase
3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in
patients with platinum-refractory head and neck cancers. This is the same trial
that the Company previously reached an agreement on with the U.S. Food and Drug
Administration (FDA) under the Special Protocol Assessment (SPA)
of this approval clears the way for final preparations at the participating
centres in anticipation of the start of enrolment in this trial and we expect to
provide an update on timing in the near future," said Dr. Brad Thompson,
President and CEO of Oncolytics. "Conducting this trial in both the U.S. and
Europe allows us to access many of the physicians that have worked with REOLYSIN
previously and, if the trial is successful, provides us with the basis for
regulatory submissions in both the key American and European
previously disclosed, the randomized, two-arm, double-blind, multicentre,
two-stage, adaptive Phase 3 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 3x1010
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.
Oncolytics intends to conduct the first stage of the trial at approximately 25
centres in the U.S., U.K., and Belgium
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 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 enrolment being 195 patients
in this stage. This adaptive trial design allows frequent data
evaluation to determine if the probability of reaching a statistically
significant endpoint has been achieved.
decision to pursue a Phase 3 trial in head and neck cancers was predicated on
positive results seen in the Company's U.K. Phase 1 and Phase 2 combination
REOLYSIN and paclitaxel/carboplatin clinical trials, as well as significant
preclinical work demonstrating synergy in combination with taxane or
platinum-based drugs. Updated results from the U.K. Phase 1/2 trial
reported in November 2009 demonstrated an overall response rate (PR and CR) of
42% and a total clinical benefit rate (PR + CR + stable disease) of
74%. The Company is currently conducting a confirmatory Phase 2 trial
in the U.S. in patients with advanced head and neck cancers.
Thompson, President and CEO of Oncolytics, will host a conference call and
webcast today, February
16th, 2010 at 2:00 p.m. MT (4:00 p.m.
ET) to update investors on the Company's ongoing clinical program for
REOLYSIN. To access the conference call by telephone, dial 1-647-427-7450 or
1-888-231-8191. A live audio webcast will also be available at the following
through the Company's website at www.oncolyticsbiotech.com. Please
connect at least 15 minutes prior to the webcast to ensure adequate time for any
software download that may be needed. A replay of the webcast will be available
and will also be available by telephone through February 23rd,
2010. To access the telephone replay, dial 1-416-849-0833 or 1-800-642-1687 and
enter reservation number 57104101#.
a proprietary formulation of the human reovirus that acts primarily as a direct
cytotoxic agent. Reovirus is naturally occurring (not genetically engineered)
and has been demonstrated to replicate specifically in tumour cells bearing an
activated Ras pathway, leaving healthy normal cells intact. At least two thirds
of carcinomas and more than 90% of metastatic disease has Ras
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 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.
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 MHRA's approval
of a Phase 3 combination REOLYSIN and paclitaxel/carboplatin trial for patients
with platinum-refractory head and neck cancers, the planned timing and
implementation of the Phase 3 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