Oncolytics Biotech® Inc. Announces Completion of Patient Enrollment in U.S. Randomized Phase II Pancreatic Cancer Study
CALGARY, July 8, 2014 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) today announced completion of patient enrollment
in a two-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 (OSU-10045).
The principal investigator is Tanios Bekaii-Saab, MD, associate
professor and gastrointestinal oncology section chief at The Ohio State
University Comprehensive Cancer Center – Arthur G. James Cancer
Hospital and Richard J. Solove Research Institute (OSUCCC – James). The
trial is sponsored by the U.S. National Cancer Institute (NCI) through
a clinical trials agreement between the Cancer Therapy Evaluation
Program, Division of Cancer Treatment and Diagnosis and Oncolytics.
Oncolytics is providing clinical supplies of REOLYSIN for the study.
“This is the second randomized study utilizing REOLYSIN to complete
enrollment,” said Dr. Brad Thompson, President and CEO of Oncolytics.
“This is an important study given the relatively limited treatment
options and generally poor prognosis for pancreatic cancer patients,
who are often not diagnosed until the more advanced stages of the
The study is an open-label, multi-institution, two-arm phase II
randomized study of patients with metastatic pancreatic cancer.
Patients were randomized to receive either carboplatin, paclitaxel plus
REOLYSIN (Arm A) or carboplatin and paclitaxel alone (Arm B). Patients
in both arms received treatment every three weeks (21-day cycles) and
standard intravenous doses of paclitaxel and carboplatin on day one
only. In Arm A, patients also received intravenous REOLYSIN at a dose
of 3×10(10) TCID(50) on days one through five. Tumor response assessment was done by
computed tomography (CT) scan and conducted every eight weeks. Patients
who progressed on carboplatin and paclitaxel (Arm B) had REOLYSIN
added. If patients experienced significant toxicity related to
carboplatin and/or paclitaxel, they could continue with single agent
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 enrolled 70 evaluable patients at
test centers across the United States.
As the sponsor of the study, the NCI is responsible for following
patients and collecting and collating all patient data. Once complete,
the data will be analyzed and provided to Oncolytics.
Bekaii-Saab, principal investigator of the clinical study, has no
financial interests in Oncolytics, manufacturer of the investigational
About Pancreatic Cancer
The American Cancer Society estimates that 46,420 Americans will be
diagnosed with pancreatic cancer and an estimated 39,590 Americans are
expected to die from the disease in 2014. 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
approximately six percent.
About The OSUCCC – James
The Ohio State University Comprehensive Cancer Center – Arthur G. James
Cancer Hospital and Richard J. Solove Research Institute strives to
create a cancer-free world by integrating scientific research with
excellence in education and patient-centered care, a strategy that
leads to better methods of prevention, detection and treatment. Ohio
State is one of only 41 National Cancer Institute (NCI)-designated
Comprehensive Cancer Centers and one of only four centers funded by the
NCI to conduct both phase I and phase II clinical trials. The NCI
recently rated Ohio State’s cancer program as “exceptional,” the
highest rating given by NCI survey teams. As the cancer program’s
228-bed adult patient-care component, The James is a “Top Hospital” in
the nation as ranked by U.S.News & World Report.
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 later-stage,
randomized human trials in various indications 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 the U.S. Securities Act of 1933, as amended, and U.S.
Securities Exchange Act of 1934, as amended, and forward-looking
information within the meaning of Canadian securities laws. Statements,
other than statements of historical facts, included in this press
release that address activities, events or developments that Oncolytics
expects or anticipates will or may occur in the future, including such
things as, the Company’s expectations related to the OSU-10045
randomized Phase 2 study of REOLYSIN in combination with carboplatin
and paclitaxel in patients with pancreatic cancer, the Company’s belief
as to the potential of REOLYSIN as a cancer therapeutic, and other such matters are forward-looking statements and
forward-looking information and 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 and
forward-looking information. Such risks and uncertainties include,
among others, risks related to the statistical sufficiency of patient
enrollment numbers in separate patient groups, 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 statement and forward-looking information. Investors
are cautioned against placing undue reliance on forward-looking
statements and forward-looking information. The Company does not
undertake to update these forward-looking statements and
forward-looking information, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.