CALGARY, Sept. 12, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics” or the “Company”) (TSX:ONC,
NASDAQ:ONCY) today provided an update on its Phase III trial of
REOLYSIN in combination with carboplatin and paclitaxel for the
treatment of head and neck cancers (REO 018).
The Company has conducted an internal analysis of the blinded combined
clinical data for all 80 patients enrolled in the first stage of the
study. The study remains blinded at this time. At the time of the
analysis, 23 patients of the 80 had not yet progressed but were
included for the purposes of analysis. The median evolving progression
free survival (PFS) of the 80 patients, which comprises the combined
control and test groups, was greater than expected, as was the best
response rate. On further examination, it was observed that patients
for whom only metastatic disease was being measured by clinicians, were
responding differently to treatment than patients who had local
regional head and neck disease. Patients in whom only metastatic
disease was measured had a median evolving PFS of 120 days, which was
statistically significantly greater than those patients with a noted
local regional head and neck tumor. There was a statistically
significant difference in PFS between these two groups (n=80, p=0.008,
hazard ratio=0.536). Oncolytics therefore believes that, based on
differential PFS, it has identified two distinct patient groups are
being enrolled in this clinical study, patients with local recurrent
disease, with or without metastases, and those with distal metastases.
Each of these two groups contains patients from both the control and
test arms of the study. Oncolytics believes that these two groups of
patients must therefore be considered to be different for the purpose
of both analysis and investigation.
The Company has consulted with its principal investigators and the
independent statistician for the study, and, on September 10, 2012, met
with the U.S. Food and Drug Administration in Washington, D.C. Based on
these discussions, the Company plans to expand enrollment in the first
stage of the study to include 160 patients, all of whom have now been
enrolled. Oncolytics intends to introduce an additional segregation to
differentiate between patients with local recurrent disease, with or
without metastases, and patients with distal metastases. Based on the
analysis of the 160 patients, Oncolytics expects to generate randomized
data from two discrete patient populations. The Company believes this
will provide a sufficient number of patients to conduct a meaningful
analysis of the two identified patient groups, as well as increased
powering for the overall analysis. Oncolytics intends to treat this
expanded first stage of the REO 018 clinical trial as a separate
supportive study to a planned registration study that will be similar
to, and take the place of, the original second stage of the REO 018
clinical trial. Enrollment in the first stage of the study is complete
and no additional patients will be enrolled pending approval of a
planned registration study. The Company intends to submit protocol
amendments to regulators in the immediate near term to reflect these
changes. It will require additional time to follow the expanded group
of patients and allow the evolving PFS data to mature.
“Segregating and separately evaluating the two identified patient groups
means we will be able to obtain our first randomized data in these two
patient populations, including one with only metastatic disease,” said
Dr. Brad Thompson, President and CEO of Oncolytics. “All six of our
randomized Phase II studies are examining indications with significant
metastatic disease involvement. Patients with metastatic disease
represent a large potential market.”
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a
conference call and webcast on Wednesday, September 12th, 2012 at 6:00 a.m. MT (8:00 a.m. ET) to discuss in more depth the
Company’s Phase III study in head and neck cancers. 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 link: http://www.newswire.ca/en/webcast/detail/1034181/1121577 or through the Company’s website at www.oncolyticsbiotech.com/presentations. Please connect at least 10 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 at www.oncolyticsbiotech.com and will also be available by telephone through September 19th, 2012. To access the telephone replay, dial 1-416-849-0833 or
1-855-859-2056 and enter reservation number 30393545 followed by the
number sign. The Company also intends to post the prepared remarks from the call to
its corporate website following the call.
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 the U.S. Securities Act of 1933, as amended, and U.S.
Securities Exchange Act of 1934, as amended, and forward-looking
information within the meaning of Canadian securities laws. Statements,
other than statements of historical facts, included in this press
release that address activities, events or developments that Oncolytics
expects or anticipates will or may occur in the future, including such
things as, intended introduction of additional segregation to
differentiate between patient groups, enrollment of 160 patients
providing sufficient numbers to conduct meaningful analysis of two
identified patient groups and increasing power of overall analysis,
treatment of expanded first stage of REO 18 clinical trial as separate
support to a planned registration study to take the place of original
second stage REO 18 clinical trial, anticipated timing for submission
of protocol amendments to regulators, the Company’s expectations
related to the Phase III head and neck cancers trial of REOLYSIN in
combination with carboplatin and paclitaxel, and the Company’s belief
as to the potential of REOLYSIN as a cancer therapeutic, and other such matters are forward-looking statements and
forward-looking information and 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 and
forward-looking information. Such risks and uncertainties include,
among others, risks related to the statistical sufficiency of patient
enrollment numbers in separate patient groups, 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 statement and forward-looking information. Investors
are cautioned against placing undue reliance on forward-looking
statements and forward-looking information. The Company does not
undertake to update these forward-looking statements and
forward-looking information, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.
Released September 12, 2012