CALGARY, June 10 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that patient enrolment
has started in a Phase 1/2 clinical trial for patients with metastatic
ovarian, peritoneal and fallopian tube cancers using concurrent intravenous
(IV) and intraperitoneal (IP) administration of REOLYSIN(R), Oncolytics’
proprietary formulation of the human reovirus. The National Cancer Institute
(NCI), 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(R). The Principal Investigator is Dr.
David E. Cohn, Associate Professor, Division of Gynecologic Oncology at The
Ohio State University College of Medicine in Columbus, Ohio.
“REOLYSIN(R) is an exciting agent to investigate in patients with ovarian
cancer,” said Dr. Cohn. “Targeting a specific alteration commonly present in
these tumors will hopefully lead to efficacy with minimal toxicity.”
“We are looking forward to working closely with the NCI to examine the
effects of using REOLYSIN(R) with two concurrent methods of administration,”
said Dr. Brad Thompson, President and CEO of Oncolytics. “Our REOLYSIN(R)
clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials
in the U.S. and the U.K. using REOLYSIN(R) as a monotherapy or in combination
with radiation or chemotherapy.”
In the Phase 1 portion of the trial, patients will receive a constant dose
of IV REOLYSIN(R) on days 1-5 every 28 days, as well as an escalating dose of
IP REOLYSIN(R) on days 1-2 every 28 days. In the Phase 2 portion of the study,
patients will receive a constant dose of IV REOLYSIN(R) on days 1-5 every 28
days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN(R) from the
Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety
and tolerability of intravenous and intraperitoneal administration of
REOLYSIN(R), and the MTD of IP REOLYSIN(R) when used with a fixed dose of IV
REOLYSIN(R). The primary objective of the Phase 2 trial is to determine the
objective response rate of treatment with IV and IP REOLYSIN(R) in patients
with recurrent, platinum-refractory ovarian, peritoneal and tubal carcinomas.
The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be
diagnosed with ovarian cancer in the U.S. in 2008, and more than 15,000 will
die from it.
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 Phase I/II and Phase II human trials
using REOLYSIN(R), its proprietary formulation of the human reovirus, alone
and in combination with radiation or chemotherapy. 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 U.S. NCI Phase I/II systemic and intraperitoneal administration clinical
trial for patients with metastatic ovarian, peritoneal and fallopian tube
cancers, and the Company’s belief as to the potential of REOLYSIN(R) 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(R) as a cancer treatment, the
tolerability of REOLYSIN(R) outside a controlled test, the success and timely
completion of clinical studies and trials, the Company’s ability to
successfully commercialize REOLYSIN(R), 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
SOURCE Oncolytics Biotech Inc.
Released June 10, 2008