CALGARY, Jan. 31 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has met the
initial criteria to proceed to full enrolment in its U.S. Phase II trial to
evaluate the intravenous administration of REOLYSIN(R) in patients with
various sarcomas that have metastasized to the lung.
According to the trial protocol, to proceed to full enrolment of 52
patients, Oncolytics had to demonstrate that at least one patient in the first
38 patients treated experienced a complete or partial response, or stable
disease for greater than six months. The third patient treated in the study
was demonstrated to have stable disease by RECIST criteria for more than six
months as measured by CT scan. A PET scan taken at the same time showed that
any residual mass was metabolically inert.
A total of 12 patients have received REOLYSIN(R) treatment to date, with
five remaining on study. All 12 patients have been treated at the Cancer
Therapy and Research Center, University of Texas Health Science Center in San
Antonio, Texas (CTRC at UTHSCSA).
“We are very pleased to proceed to the second stage of the REOLYSIN(R)
study,” said Dr. Monica Mita, Principal Investigator at CTRC at UTHSCSA. “This
unique targeted compound has met our expectations so far in terms of both
tolerability and efficacy endpoints and we feel it is very important to
continue to offer this agent to our patients.”
“While still early, these are very encouraging results,” said Dr. Karl
Mettinger, Chief Medical Officer of Oncolytics. “There are few treatment
options for patients with bone or soft tissue cancers, and we are pleased that
the trial participants appear to be benefiting from REOLYSIN(R) treatment.”
Patients are expected to be enrolled at three additional sites, which
include the Montefiore Medical Center/Albert Einstein College of Medicine in
the Bronx, New York, the University of Michigan Comprehensive Cancer Center in
Ann Arbor, Michigan, and the Mayo Clinic in Rochester, Minnesota.
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(R) in patients with bone and soft tissue sarcomas metastatic to the
lung. REOLYSIN(R) is delivered intravenously to patients at a dose of 3×10(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.
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.S. Phase II sarcoma 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 January 31, 2008