CALGARY, Oct. 23 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a
letter of approval from the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA) for its Clinical Trial Application (CTA) to begin 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.
The Company also intends to host a conference call Wednesday, October 24,
2007 to provide an update on its expanding clinical program. The dial-in
details appear below.
“We are really looking forward to treating patients in this trial,” said
Principal Investigator Dr. James Spicer. “The hope is that it will provide
valuable information about the relationship between oncolytic viral therapy
and the immune response of the patient.”
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 the safety profile of the combination and gathering any evidence of
anti-tumour activity.
Conference Call Details
Oncolytics will host a conference call at 2:00 p.m. EST on Wednesday,
October 24, 2007, to provide a general update on its ongoing clinical trial
program. To access the conference call by telephone, dial 1-416-644-3414 or
1-800-731-5319. A live audio webcast will be available at:
http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2054580 or through the
Company’s website at www.oncolyticsbiotech.com. Please connect at least 15
minutes prior to the webcast to ensure adequate time for any software download
that may be needed. A replay of the webcast will be available at
www.oncolyticsbiotech.com and will also be available by telephone through
October 31, 2007. To access the telephone replay, dial 1-416-640-1917 or
1-877-289-8525 and enter reservation number 21251367 followed by the number
sign.
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 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.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 October 23, 2007