CALGARY, Feb. 14 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) today announced preliminary results from a U.S.
Phase 2 clinical trial (REO 017) using intravenous administration of
REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. The trial is being
conducted at the Cancer Therapy & Research Center at The University of
Texas Health Science Center at San Antonio (CTRC). The Principal
Investigator is Dr. Monica Mita of the CTRC.
“When we opened the study we anticipated positive results based on
preclinical models and on the high frequency of Ras pathway
abnormalities in pancreatic cancer,” said Dr. Monica Mita. “We are,
however, impressed by the fact that the study met the endpoint so
early. We are eager to complete the study and to proceed to the next
step of development for this combination.”
The trial is a single arm, open-label, Phase 2 study of REOLYSIN given
intravenously with gemcitabine every three weeks. The study’s primary
objective is to determine the clinical benefit rate (complete response
(CR) + partial response (PR) + stable disease (SD)) of REOLYSIN in
combination with gemcitabine in patients with advanced or metastatic
pancreatic adenocarcinoma with measurable disease who have not received
any prior chemotherapy or biotherapy. The secondary objectives are to
determine progression-free survival, and the safety and tolerability of
REOLYSIN when administered in combination with gemcitabine. Seventeen
evaluable patients with pancreatic cancer were expected to be treated
in the first stage and if three or more patients received clinical
benefit, the study would then proceed to the next stage. This endpoint
was met after six evaluable patients were enrolled. All patients
treated reported symptomatic improvement. Three of six patients showed
SD for 12 weeks or greater. In addition, one patient had stable disease
at nine weeks of treatment, but was taken off of the study for
alternative treatment, and one patient had a PR of less than 12 weeks
duration, and then died from a medical issue unrelated to treatment.
The Company now intends to complete enrollment in the first stage of
the study and then continue with further studies.
“This study is supportive of the decision to conduct the randomized
Phase II study being sponsored by the NCI examining REOLYSIN in
combination with carboplatin/paclitaxel,” said Dr. Brad Thompson,
President and CEO of Oncolytics.
About Pancreatic Cancer
The American Cancer Society estimates that 43,140 Americans were
diagnosed with pancreatic cancer and 36,800 Americans died from the
disease in 2010, 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.
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.
The Cancer Therapy & Research Center (CTRC) at The University of Texas
Health Science Center at San Antonio is one of the elite academic cancer centers in the country to be named
a National Cancer Institute (NCI) Designated Cancer Center, and is one
of only four in Texas. A leader in developing new drugs to treat
cancer, the CTRC Institute for Drug Development (IDD) conducts one of
the largest oncology Phase I clinical drug programs in the world, and
participates in development of cancer drugs approved by the U.S. Food &
Drug Administration. For more information, visit www.ctrc.net.
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/gemcitabine clinical trial for patients with 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
SOURCE Oncolytics Biotech Inc.
Released February 14, 2011