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

Oncolytics Biotech® Inc. Meets Primary Endpoint for First Stage of U.S. Phase 
2 Metastatic Melanoma Trial 
CALGARY, May 22, 2013 /CNW/ - 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 
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 
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: 
This press release contains forward-looking statements, within the meaning of 
Section27A 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 
The Equicom Group Nick Hurst 300 5th Ave. SW, 10th Floor Calgary, Alberta, T2P 
3C4 Tel: 403.218.2835 Fax: 403.218.2830 nhurst@tmxequicom.com  Dian Griesel, 
Inc. Susan Forman 396 West Broadway, 2nd Floor New York, NY 10012 Tel: 
212.825.3210 Fax: 212.825.3229 sforman@dgicomm.com   
SOURCE: Oncolytics Biotech Inc. 
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CO: Oncolytics Biotech Inc.
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-0- May/22/2013 10:30 GMT
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