CALGARY, Dec. 11 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ:ONCY) announced today that it has exceeded the primary statistical
endpoint in its multi-centre Phase 2 clinical trial to evaluate the
intravenous administration of REOLYSIN® in patients with various sarcomas
that have metastasized to the lung.
"The proportion of patients on study with significant, durable,
clinically meaningful responses is highly encouraging," said Dr. Frank Giles,
Director of the Institute of Drug Development, the Cancer Therapy and Research
Center at the University of Texas Health Science Center, San Antonio, Texas.
"This very novel agent has delivered a positive answer to its first critical
efficacy question."
To meet the statistical endpoint, at least three out of 52 patients had
to experience stabilization of disease or better for more than six months. Of
33 evaluable patients treated to date, five have experienced stable disease
for periods greater than six months, including one patient who has maintained
stable disease for more than 16 months. An additional 10 patients have
experienced stable disease for periods ranging from three to six cycles (cycle
= 28 days). Twelve patients are continuing on study, including the five
patients who have been stable for more than six months.-------------------------------------------------------------------------
Tumour Type
Months on Study
Best Response
-------------------------------------------------------------------------
Synovial sarcoma
16(*)
SD
-------------------------------------------------------------------------
Ewing's sarcoma
9(*)
SD
-------------------------------------------------------------------------
Osteosarcoma
9(*)
SD (tumour resection
after cycle 4)
-------------------------------------------------------------------------
Chordoma
6(*)
SD
-------------------------------------------------------------------------
Unspecified Spindle Cell
6(*)
SD
-------------------------------------------------------------------------
(*) patients still on study"We are very pleased to have met the statistical endpoint in our first
U.S. Phase 2 study, particularly in such a difficult-to-treat form of cancer,"
said Dr. Brad Thompson, President and CEO of Oncolytics. "The interim data
indicate that REOLYSIN® is active in various types of metastatic sarcoma,
and that late-stage clinical trials are justified."
Sarcomas are malignant tumors growing from connective tissues, such as
cartilage, fat, muscle, or bone. According to the American Cancer Society,
only 16.3% of patients with distant spread of sarcoma live longer than five
years. There is an unmet medical need for effective treatments for patients
with this type of disease.
Clinical Trial Design
The trial (REO 014) is a Phase 2, 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® is delivered intravenously to patients at a dose of 3x10(10)
TCID(50) for five consecutive days, every 28 days. 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/II 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, except as required by applicable
laws.
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