Oncolytics Biotech Inc. Announces Positive Top Line REOLYSIN(R) Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers
CALGARY, Dec. 13, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics” or
the “Company”) (TSX: ONC) (NASDAQ: ONCY) today announced initial
positive top line data from the first endpoint in its double-blinded
randomized Phase III clinical study examining REOLYSIN in combination
with carboplatin and paclitaxel in second-line patients with
platinum-refractory, taxane-naÃ¯ve head and neck cancers (REO 018).
The endpoint examines initial percentage tumour changes between the
pre-treatment and first post-treatment scans (typically performed at
six weeks post-first treatment) of all patients enrolled in the study.
The analysis was designed to assess early differences in response
between loco-regional tumours and metastatic tumours, as classified and
observed by the investigators. This is the first, and to this point
only, endpoint to be un-blinded for this study.
The first analysis compared the relative percentages of patients in the
test and control arms with tumours that had either stabilized or
exhibited shrinkage. For the purposes of this endpoint, the definition
of tumour stabilization was restricted to zero percent growth only. Of
the 105 total patients with evaluable metastatic tumours, 86 percent
(n=50) of those in the test arm of the study exhibited tumour
stabilization or shrinkage, compared with 67 percent of patients (n=55)
in the control arm. This was statistically significant, with a p-value
The second analysis examined the magnitude of tumour response on a per
patient basis using a comparison of percentage tumour shrinkage at six
weeks in each patient with evaluable metastatic tumours. This analysis
showed that REOLYSIN in combination with carboplatin and paclitaxel was
statistically significantly better than carboplatin and paclitaxel
alone at stabilizing or shrinking metastatic tumours, yielding a
p-value of 0.03.
At the six week point, there is a numeric trend in favour of the test
group towards differing activity between the test and control groups in
patients with loco-regional tumours.
In an intragroup analysis of the test arm, an improvement in the
percentage of patients’ metastatic tumours over loco-regional tumours
was noted (p=0.083) and an improvement of magnitude of response in
metastatic tumours over loco-regional tumours was also noted (p=0.13).
By contrast, in an intragroup analysis of the control arm, no
statistical differences were noted between the responses of patients
with evaluable metastatic tumours and patients with evaluable
“To the best of our knowledge, this is the first successful
double-blinded randomized data from a clinical study using an
intravenously-administered oncolytic virus. We are delighted to have
obtained statistically significant data for REOLYSIN in a randomized
clinical setting,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “We continue to await the data for the other endpoints of
this study, to which all parties still remain blinded at this point.”
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a
conference call and webcast on Thursday, December 13(th), 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/1087657/1184933 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/presentations and will also be available by telephone through December 20(th), 2012. To access the telephone replay, dial 1-416-849-0833 or
1-855-859-2056 and enter reservation number 81080621 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, 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.