Last updated on April 16, 2014 at 11:49 EDT

Oncolytics Biotech(R) Inc. Announces Positive Results of U.S. Phase 2 Clinical Trial Investigating REOLYSIN(R) in Combination with Paclitaxel and Carboplatin in Head and Neck Cancers

November 14, 2011

CALGARY, Nov. 14, 2011 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) today announced that positive results from a
Phase 2 clinical trial (REO 015) using intravenous administration of
REOLYSIN(®) in combination with paclitaxel and carboplatin in patients with
advanced head and neck cancers will be presented at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics.
The conference is being held in San Francisco, CA from November 12(th) to 16(th) 2011. The Principal Investigator of the U.S. study was Dr. Monica Mita
of the Cancer Therapy & Research Center at The University of Texas
Health Science Center at San Antonio (CTRC).

The U.S. trial was a single arm open-label, phase-2 study of REOLYSIN
given intravenously with paclitaxel (175 mg/m(2)) and carboplatin (AUC 5) every three weeks in patients with
platinum-refractory recurrent and/or metastatic squamous cell cancers
of the oral cavity, larynx, or pharynx. The primary end point was to
determine the objective response rate (complete response (CR) + partial
response (PR)) of the treatment regimen in the study population.
Secondary objectives included the determination of disease control rate
(CR + PR + stable disease (SD)) and the safety and tolerability of the
treatment regimen.

Of the 14 enrolled patients, all had received prior chemotherapy,
radiotherapy, or combinations thereof for their metastatic or recurrent
disease. Ten of the 14 patients received prior chemotherapy treatment
with taxanes. Of the 13 patients evaluable for response, four had PRs,
for an objective response rate of 31%. Six patients had SD or better
for 12 weeks or longer for a disease control rate (SD or better) of
46%. Two of the four patients with PRs and both patients with SD had
received prior treatment with taxanes.

“This study was undertaken as a confirmatory trial of an earlier study
performed in the UK with a similar patient population (REO 011). It
confirmed the high rate of responses observed in the U.K. study, and
was noteworthy as this U.S. patient population included a higher
proportion of patients that had failed prior taxane-based therapy,”
said Dr. Matt Coffey, COO of Oncolytics. “Historically, head and neck
cancer has been characterized by a very low rate of success in
treatment of patients who have already failed chemotherapy. Standard
second-line therapies for platinum refractory head and neck cancer
using currently approved cytotoxics have yielded 3 to 7% response rates(1).”

“These data further confirm the utility of REOLYSIN in this indication,
even in a heavily pre-treated patient population,” said Dr. Brad
Thompson, President and CEO of Oncolytics. “These results are an
important step towards making this potential therapy available to head
and neck cancer patients, and represent a significant milestone for

(1)Le³n X et al. (2005) A retrospective analysis of the outcome of patients
with recurrent and/or metastatic squamous cell carcinoma of the head
and neck refractory to a platinum-based chemotherapy. ClinOncol 17:
418-424; Specenier P et al. (2011) Weekly Docetaxel in Patients With
Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and
Neck. Am J ClinOncol 34: 472-7.

Conference Call Information
Dr. Brad Thompson, President and CEO of Oncolytics, will host a
conference call and webcast on Monday, November 14(th), 2011 at 6:30 a.m. MT (8:30 a.m. ET) to discuss in more depth the
presentation covering the U.S. Phase II head and neck cancer data. 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/viewEvent.cgi?eventID=3743300 or through the Company’s website at www.oncolyticsbiotech.com. 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 November 21(st), 2011. To access the telephone replay, dial 1-416-849-0833 or
1-855-859-2056 and enter reservation number 27729561 followed by the
number sign.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of oncolyticviruses 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 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 combination
REOLYSIN/paclitaxel/carboplatin clinical trial for patients with
advanced head and neck cancers, 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 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 statements. 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