Oncolytics Biotech Inc. Commences Patient Enrolment in U.S. Phase II Sarcoma Clinical Trial
http://www.integratir.com/newsrelease.asp?news=2130983233&ticker=T.ONC&lang=EN&ny=on
6/27/2007 2:00:00 AM ET
CALGARY, AB, --- June 27, 2007 -
Oncolytics Biotech
Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that patient
enrolment has commenced in its U.S. Phase II trial to evaluate the intravenous
administration of
REOLYSIN®
in patients with various sarcomas that have metastasized to the lung. Patients
are being enrolled at the Montefiore Medical Center/Albert Einstein College of
Medicine in the Bronx, New York, the University of Michigan Comprehensive Cancer
Center in Ann Arbor, and the Cancer Therapy and Research Center, Institute for
Drug Development in San Antonio, Texas.
“The initiation of this trial represents an important milestone for the
Company,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are now
treating patients with advanced cancers in Phase II clinical trials in the U.S.
and the U.K., with additional Phase II trials expected to begin before the end
of the year. These trials are expected to yield information that will guide the
late stage clinical development program for REOLYSIN®.”
The trial (REO 014) is a Phase II, open-label, single agent study whose primary
objective is to measure tumour responses and duration of response, and to
describe any evidence of antitumour activity of intravenous, multiple dose
REOLYSIN® in patients with bone and soft tissue sarcomas metastatic to the lung.
REOLYSIN® will be given intravenously to patients at a dose of 3x10(10) TCID(50)
for five consecutive days. Patients may receive additional five-day cycles of
therapy every four weeks for a maximum of eight cycles. Up to 52 patients will
be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung
deemed by their physician to be unresponsive to or untreatable by standard
therapies. These include patients with osteosarcoma, Ewing sarcoma family
tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and
leiomyosarcoma.
“There are very few treatment options for patients with bone or soft tissue
sarcomas,” said Dr. Matt Coffey, Oncolytics’ Chief Scientific Officer. “Our
decision to choose this indication is based on the observed activity of REOLYSIN®
against sarcomas in both preclinical and clinical studies.”
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®,
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. Phase II
sarcoma clinical trial and the Company’s belief as to the potential of REOLYSIN®
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® 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 statements. Investors are
cautioned against placing undue reliance on forward-looking statements. The
Company does not undertake to update these forward-looking statements.
FOR FURTHER INFORMATION PLEASE CONTACT:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7377
Fax: 403.283.0858
cathy.ward@oncolytics.ca
The Equicom Group
Nick Hurst
325, 300 5th Ave. SW
Calgary, AB, T2P 3C4
Tel: 403.538.4845
Fax: 403.237.6916
nhurst@equicomgroup.com
The Investor Relations Group
Erika Moran
11 Stone St, 3rd Floor
New York, NY 10004
Tel: 212.825.3210
Fax: 212.825.3229
emoran@investorrelationsgroup.com