CALGARY, Jan. 18 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC, NASDAQ: ONCY) announced today that the Cancer Therapy
Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S.
National Cancer Institute (NCI), which is part of the National
Institutes of Health, has agreed to sponsor a 2-Arm randomized Phase II
study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of
patients with recurrent or metastatic pancreatic cancer. The NCI is
sponsoring the trial under its Clinical Trials Agreement with
Oncolytics, while Oncolytics will provide clinical supplies of
REOLYSIN. The Principal Investigator is Dr. Tanios Bekaii-Saab of The
Ohio State University Comprehensive Cancer Center - Arthur G. James
Cancer Hospital and Richard J. Solove Research Institute.
"Pancreatic cancer is typically diagnosed at a later stage, when there
is a poor prognosis for long-term survival," said Dr. Tanios
Bekaii-Saab, principal investigator. "Although the standard of care has
evolved over the last few years, it has only managed to generate very
modest improvements in response rate and median overall survival. Given
these poor outcomes, we are eager to evaluate new and promising
treatments in this indication."
The study is an open-label, multi-institution, 2-arm Phase II randomized
study of patients with metastatic pancreatic cancer. Patients will be
randomized to receive either carboplatin, paclitaxel plus REOLYSIN (Arm
A) or carboplatin and paclitaxel alone (Arm B). Patients in both arms
will receive treatment every three weeks (21-day cycles). Patients in
both arms will be receiving standard intravenous doses of paclitaxel
and carboplatin on day one only. In Arm A, patients will also receive
intravenous REOLYSIN at a dose of 3x1010 TCID50 on days one through five. Tumor response assessment will be done by CT
scan and conducted every eight weeks. Patients that progress on
carboplatin and paclitaxel (Arm B) will have REOLYSIN added. If
patients experience significant toxicity related to carboplatin and/or
paclitaxel they may continue with single agent REOLYSIN.
The primary objective of the trial is to assess improvement in
progression-free survival with REOLYSIN, carboplatin and paclitaxel
relative to carboplatin and paclitaxel alone in patients with
metastatic pancreatic cancer. The primary endpoint is progression free
survival in both arms. Secondary endpoints include overall response
rate and overall survival. The study is expected to enroll
approximately 70 patients.
"We continue to expand our clinical relationship with the NCI, as they
push forward innovative research initiatives," said Dr. Brad Thompson,
President and CEO of Oncolytics. "Partnering with the NCI allows us to
cost-effectively expand the evaluation of REOLYSIN into new
indications, with a focus on identifying additional targets for future
late-stage clinical testing."
This is the fourth clinical trial using REOLYSIN to be sponsored by the
NCI. The NCI is currently conducting a Phase II metastatic melanoma
trial, a Phase I/II ovarian, peritoneal and fallopian tube cancer
trial, and has announced its intention to sponsor a randomized Phase II
trial in patients with persistent or recurrent ovarian, fallopian tube
or primary peritoneal cancer.
About Pancreatic Cancer
The American Cancer Society estimates that 43,140 Americans were
diagnosed with pancreatic cancer and an estimated 36,800 Americans were
expected to die from the disease in 2010. The prognosis for patients
diagnosed with pancreatic cancer, regardless of stage, is generally
poor; the relative five-year survival rate for all stages combined is
About the NCI
The U.S. National Cancer Institute (NCI) is part of the National
Institutes of Health and the U.S. Department of Health and Human
Services. NCI's main responsibilities include coordinating the National
Cancer Program; conducting and supporting cancer-related research;
training physicians and scientists; and disseminating state-of-the-art
information about cancer detection, diagnosis, treatment, prevention,
control, palliative care, and survivorship.
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.
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 Phase 2 randomized pancreatic cancer trial
sponsored by the NCI, 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.
For further information:
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