Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN(R) in Combination With Cyclophosphamide
23/10/2007 23:26
PR Newswire
CALGARY, Canada, October 23 /PRNewswire/ -- 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(equal sign)2054580 or
through the Company's website at http://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 http://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 http://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.
Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: +1-403-670-7377, Fax: +1-403-283-0858, cathy.ward@oncolytics.ca; The Equicom Group, Nick Hurst, 325, 300 5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: +1-403-538-4845, Fax: +1-403-237-6916, nhurst@equicomgroup.com; The Investor Relations Group, Erika Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: +1-212-825-3210, Fax: +1-212-825-3229, emoran@investorrelationsgroup.com