Oncolytics Biotech Inc.
("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced that the U.S.
National Cancer Institute (NCI), part of the National Institutes of Health,
has started enrolment in a Phase 2 clinical trial for patients with
metastatic melanoma using systemic administration of REOLYSIN(R),
Oncolytics' proprietary formulation of the human reovirus. The trial is
being carried out by the Mayo Phase 2 Consortium under the NCI's Clinical
Trials Agreement with Oncolytics, while Oncolytics will provide clinical
supplies of REOLYSIN(R). The Principal Investigator is Dr. Evanthia Galanis
of the Mayo Clinic Cancer Center.
The primary objectives of the study are to assess the antitumour
effects of REOLYSIN(R) in patients with metastatic malignant melanoma, as
well as the safety profile of REOLYSIN(R). Secondary objectives include
assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN(R) at a dose
of 3x10(10) TCID(50) per day on days 1-5 of each 28 day cycle, and patients
may receive up to 12 cycles of treatment. The trial is expected to enroll
up to 47 patients with metastatic melanoma.
Approximately 60,000 people are diagnosed with melanoma in the U.S.
every year.
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(R), its proprietary formulation of the human
reovirus, alone and in combination with radiation or chemotherapy. For
further information about Oncolytics, please visit
oncolyticsbiotech
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. NCI Phase 2 systemic administration clinical trial for patients
with metastatic melanoma, 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.
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