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Last updated on April 16, 2014 at 6:04 EDT

Oncolytics Biotech(R) Inc. Meets Primary Endpoint for First Stage of U.S. Phase 2 Metastatic Melanoma Trial

May 22, 2013

CALGARY, May 22, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) today announced preliminary results from its
U.S. Phase 2 clinical trial in patients with metastatic melanoma using
intravenous administration of REOLYSIN(®) in combination with carboplatin and paclitaxel (REO 020). The Principal
Investigator is Dr. Devalingam Mahalingam, M.D., Ph.D., MRCP(UK),
MRCP(I), clinical investigator in GI/thoracic oncology and drug
development at the Cancer Therapy & Research Center at the University
of Texas Health Science Center (CTRC).

Eligible patients include those with metastatic malignant melanoma who
have failed one or more prior therapies or those not considered a
candidate for standard first line therapy. The primary objective of the
Phase 2 trial is to assess the antitumour effect of the treatment
regimen in the study population in terms of objective response rates.
The secondary objectives are to assess progression-free survival and
overall survival for the treatment regimen; the disease control rate
(complete response (CR) plus partial response (PR) plus stable disease
(SD)) and duration, and to assess the safety and tolerability of the
treatment regimen in the study population.

The study is a two stage design. Up to 18 evaluable patients with
metastatic melanoma were to be treated in the first stage. If three or
more patients demonstrated a PR or better, the study could then proceed
to the second stage, with up to 43 patients being treated in the entire
study. This endpoint was met after 14 evaluable patients were
enrolled.  Three of 14 patients exhibited a PR, and an additional seven
patients had SD for a disease control rate of 71.5%.

Past research has indicated that human melanoma cell lines were highly
permissive to reovirus type 3 Dearing in in vitro experiments, and that intravenous administration of the virus as a
monotherapy resulted in significant tumour growth retardation. A
subsequent Phase 2 monotherapy intravenous administration clinical
study demonstrated viral replication in biopsy samples of patients. A
Phase 1 all comers intravenous administration clinical study in
combination with docetaxel demonstrated partial response and stable
disease outcomes in a small (four) melanoma patient subpopulation.

“These preliminary results are very encouraging and support progressing
to subsequent studies,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “Past clinical research has shown that REOLYSIN delivered
intravenously replicates in melanoma tumours, and this is the second
clinical study to demonstrate responses in patients with REOLYSIN in
combination with other therapeutics.”

The emergence of genotyping and increasingly targeted therapies is
changing how cancer is treated. As a result of recent and potential
additional near-term changes to the standard of care for the treatment
of melanoma which include agents targeting B-Raf and PD-1, Oncolytics
is now conducting research to evaluate REOLYSIN in combination with
other emerging treatments for a number of patient sub-populations. The
Company intends to continue with a follow on clinical study in melanoma
once this research is concluded.  On that basis, the second stage of
this clinical trial will not proceed at this time.

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 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements, including the Company’s expectations
related to the U.S. Phase 2 metastatic melanoma cancer trial, future
trials in this indication, 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,
development and manufacturing of pharmaceuticals, changes in
technology, general changes to the economic environment 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
should consider statements that include the words “believes”,
“expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”,
“should”, or other expressions that are predictions of or indicate
future events or trends, to be uncertain and forward-looking. 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.


Source: PR Newswire