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 disease."
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 3x1010
TCID50 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 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 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 drug REOLYSIN.
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.