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

PR Newswire

CALGARY, 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 

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 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:

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 

SOURCE Oncolytics Biotech Inc.


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