Oncolytics Biotech(R) Inc. Announces Start of Enrollment in Randomized Phase II Pancreatic Cancer Study
(TSX:ONC, NASDAQ:ONCY) announced today that enrollment has begun in a
2-Arm randomized Phase II study of carboplatin, paclitaxel plus
REOLYSIN((R)) versus carboplatin and paclitaxel alone in the first line treatment of
patients with recurrent or metastatic pancreatic cancer. The Principal
Investigator is Dr.
Gastrointestinal Oncology at The
Cancer Center – Arthur G. James Cancer Hospital and
Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI),
which is part of the National Institutes of Health, is sponsoring the
trial under its Clinical Trials Agreement with Oncolytics, while
Oncolytics will provide clinical supplies of REOLYSIN.
“Pancreatic cancer has seen very little progress over the last few
decades,” said Dr.
clinical trial will allow us to evaluate a promising new treatment for
pancreatic cancer with the goal of improving long-term survival for
patients who typically have a poor prognosis.”
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 3×10(10) TCID(50) 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.
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
Cancer Hospital and Richard J. Solove Research Institute
(cancer.osu.edu) is one of only 40 Comprehensive Cancer Centers in
U.S. News & World Report among the top cancer hospitals in the nation,
The James is the 205-bed adult patient-care component of the cancer
program at The
seven funded programs in the country approved by the NCI to conduct
both Phase I and Phase II clinical trials.
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
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.