CALGARY, May 9 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has begun
patient enrolment in a clinical trial using intravenous administration of
REOLYSIN(R) in combination with cyclophosphamide, a chemotherapeutic agent as
well as immune modulator, in patients with advanced cancers. The Principal
Investigators are Dr. James Spicer of King’s College in London, Dr. Johann de
Bono and Dr. Kevin Harrington of The Royal Marsden NHS Foundation Trust and
The Institute of Cancer Research, London, and Professor Hardev Pandha of the
Royal Surrey County Hospital NHS Trust, Surrey and Mount Alvernia Hospitals.
“We are hopeful that this trial will provide more information on how we
might improve the effectiveness of this promising new approach to treating
cancer,” said Dr. Spicer.
“In animal models, pretreatment with low-dose immune modulators has been
shown to significantly enhance the antitumour activity of REOLYSIN(R)(ref.),”
added Dr. Brad Thompson, President and CEO of Oncolytics. “This study will
help confirm if this can also be achieved in humans. If it can, it could lead
to exciting opportunities to expand the use of REOLYSIN(R) for cancer
treatment.”
The trial (REO 012) is an open-label, dose-escalating, non-randomized
trial of REOLYSIN(R) given intravenously with escalating doses of
cyclophosphamide. A standard dose of REOLYSIN(R) is administered intravenously
over five consecutive days, while an intravenous dose of cyclophosphamide is
administered three days before REOLYSIN(R) treatment and continues through the
course of the treatment cycle. The total number of patients studied will
depend on the number of dose levels tested, but it is anticipated to be
approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or
metastatic solid tumours including pancreatic, lung and ovarian cancers that
are refractory (have not responded) to standard therapy or for which no
curative standard therapy exists. The primary objectives of the trial include
determining the Minimum Effective Immunomodulatory Dose (MED) of
cyclophosphamide to obtain successful immune modulation. Secondary objectives
include determining the safety profile of the combination and gathering any
evidence of anti-tumour activity.
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.
Ref:
Clin. Cancer Res. 2008 14:259-269
Cancer Gene Ther. 2006 Aug; 13(8): 815-8
Cancer Res, 2003 Jan 15; 63(2):348-53
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.K. combination REOLYSIN(R)/cyclophosphamide clinical trial, 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
statements.
SOURCE Oncolytics Biotech Inc.
Released May 9, 2008