CALGARY, Oct. 24, 2012 /PRNewswire/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC, NASDAQ:ONCY) today announced that it has completed patient
enrollment in its U.S. Phase II clinical trial using intravenous
administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017).
The trial is a 33-patient study using a one sample, two-stage design. In
the first stage, 17 patients were to be enrolled, and best response
noted. If three or more responses were observed (defined as complete
response (CR) or partial response (PR) or stable disease (SD) for 12
weeks or more) among the 17 patients, the study would enroll an
additional 16 patients for a total of 33 evaluable patients. As
previously disclosed, this initial endpoint was met after six evaluable
patients were enrolled. The primary objective of the trial is to
determine the clinical benefit rate (CR + PR + SD) of intravenous
multiple doses of REOLYSIN in combination with gemcitabine in patients
with advanced or metastatic pancreatic cancer. The secondary objectives
are to determine the progression-free survival (PFS), and to determine
the safety and tolerability of REOLYSIN when administered in
combination with gemcitabine.
"Completion of enrollment in this study is another positive step forward
for our clinical program," said Dr. Brad Thompson, President and CEO of
Oncolytics. "The results from this study will be cross referenced with
the results of the randomized Phase II pancreatic cancer clinical study
using REOLYSIN in combination with carboplatin and paclitaxel that is
currently enrolling patients in the U.S."
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 using
REOLYSIN®, its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
About Pancreatic Cancer
The American Cancer Society estimates that 43,920 Americans will be
diagnosed with pancreatic cancer and 37,390 Americans will die from the
disease in 2012, making this type of cancer the fourth leading cause of
cancer death for both men and women in the United States. For more
information about pancreatic cancer, please go to www.cancer.org.
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 II clinical trial investigating
REOLYSIN in combination with Gemcitabine in patients with advanced or
metastatic pancreatic cancer, 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.