Oncolytics Biotech® Receives Special Protocol Assessment Agreement from FDA for Phase 3 Clinical Trial of Pelareorep In Meta...
10 Mai 2018 - 1:00PM
Oncolytics Biotech® Inc. (TSX:ONC) (OTCQX:ONCYF), currently
developing REOLYSIN® (pelareorep), an intravenously delivered
immuno-oncolytic virus turning cold tumors hot, today announced
that it has reached an agreement with the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) for
the protocol design, clinical endpoints and statistical analysis
approach for the company's phase 3 study evaluating pelareorep for
the treatment of metastatic breast cancer. The company previously
received Fast Track Designation for pelareorep for the treatment of
metastatic breast cancer in May 2017.
"This agreement with the FDA, outlining the
specific clinical pathway forward in metastatic breast cancer, is
an important milestone in advancing pelareorep along a path to
potential regulatory approval," said Dr. Matt Coffey, President and
CEO of Oncolytics Biotech. "It’s a confirmation from the FDA that
our design and protocols will support an application for approval
and advances pelareorep to be a phase 3 asset. We now look forward
to implementation of the Agency’s guidance and to the advancement
of pelareorep through this final phase of clinical
development."
Final details of the phase 3 clinical trial will
be made available at the launch of the study and on
www.clinicaltrials.gov.
About
REOLYSIN/Pelareorep REOLYSIN, also known as
pelareorep, is a non-pathogenic, proprietary isolate of the
unmodified reovirus: a first-in-class intravenously delivered
immuno-oncolytic virus for the treatment of solid tumors and
hematological malignancies. The compound induces selective tumor
lysis and promotes an inflamed tumor phenotype through innate and
adaptive immune responses to treat a variety of cancers.
About Oncolytics Biotech
Inc.Oncolytics is a biotechnology company developing
REOLYSIN®, also known as pelareorep, an intravenously delivered
immuno-oncolytic virus. The compound induces selective tumor lysis
and promotes an inflamed tumor phenotype -- turning "cold" tumors
"hot" -- through innate and adaptive immune responses to treat a
variety of cancers. Oncolytics' clinical development program
emphasizes three pillars: chemotherapy combinations to trigger
selective tumor lysis and immuno-therapy and immune modulator
(IMiD) combinations to produce innate and adaptive immune
responses. Oncolytics is currently planning its first registration
study in metastatic breast cancer, as well as studies in
combination with checkpoint inhibitors and targeted and IMiD
therapies in solid and hematological malignancies. For further
information, 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 and forward-looking information
under applicable Canadian securities laws (such forward-looking
statements and forward-looking information are collectively
referred to herein as “forward-looking statements”).
Forward-looking statements, including the Company's belief as to
the potential and mode of action of REOLYSIN, also known as
pelareorep, as a cancer therapeutic; and other statements related
to anticipated developments in the Company's business and
technologies 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 pelareorep as a cancer treatment, the success and timely
completion of clinical studies and trials, the Company's ability to
successfully commercialize pelareorep, uncertainties related to the
research and development of pharmaceuticals, uncertainties related
to the regulatory process and general changes to the economic
environment. 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.
Company ContactMichael MooreVice President,
Investor Relations & Corporate
Communications858-886-7813mmoore@oncolytics.ca |
|
Investor
RelationsRobert UhlWestwicke Partners858-356-5932
robert.uhl@westwicke.com |
Media
ContactJason SparkCanale Communications
619-849-6005jason@canalecomm.com |
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