Outcome supports focus on HR+/HER2- patient
group that reported an
effective doubling of median overall survival from 10.8 to 21.0
months
CALGARY and SAN DIEGO, Sept. 18,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN® (pelareorep) a
first-in-class, intravenously delivered immuno-oncolytic virus that
activates the innate and adaptive immune systems, today announced a
successful End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) for REOLYSIN in combination with paclitaxel,
for the treatment of hormone receptor positive, HER2 receptor
negative (HR+/HER2-) metastatic breast cancer (mBC) patients. The
purpose of the meeting was to discuss the preclinical and clinical
programs, including the design of the phase 3 registration study to
support a future Biologics License Application (BLA) submission in
the U.S.
"The FDA's feedback and positive End-of-Phase 2 meeting outcome
support our proposed target patient population of HR positive/HER2
negative metastatic breast cancer patients for our registration
study," said Dr. Matt Coffey,
President and CEO of Oncolytics Biotech. "With statistically
significant and clinically compelling overall survival data, Fast
Track designation and now clear guidance from the FDA, we are
focused on finalizing the adaptive study design that will include
approximately four hundred patients with a pre-determined interim
analysis. Importantly, the FDA provided guidance that if the study
achieves its primary endpoint, then it will be the only study
required for BLA approval. The design of the study and this
FDA guidance will also continue to drive our partnering
process."
Oncolytics' proposed target population for its phase 3 study of
pelareorep is patients with HR+/HER2- mBC, which represents
approximately 73 percent of metastatic breast cancer cases that
have limited treatment options that offer survival benefit. Details
of the pivotal phase 3 registration study will be made available
following evaluation and completion of discussions with clinical
advisors, European regulators and potentially partners.
About Metastatic Breast Cancer
Metastatic breast
cancer, also known as advanced or Stage 4 breast cancer, has
spread to other parts of the body. Most commonly the lungs,
liver, bones or brain. The disease affects over 154,000 women
in the United States and according
to the American Cancer Society, has a five-year survival rate of
just 22 percent. Significantly lower than stage 3, with a five-year
relative survival rate of 72 percent and stage 2, with a five-year
survival rate over 90 percent.
About REOLYSIN
REOLYSIN® 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, an intravenously
delivered immuno-oncolytic virus. The compound induces selective
tumor lysis and promotes an inflamed tumor phenotype 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;
immuno-therapy combinations to produce adaptive immune responses;
and immune modulator (IMiD) combinations to facilitate innate
immune responses. Oncolytics is currently planning its first
registration study in metastatic breast cancer, as well as studies
in combination with checkpoint inhibitors as well as targeted and
IMiD therapies in solid and hematological malignancies. 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 belief as to the potential of REOLYSIN® as a
cancer therapeutic; the Company's expectations as to the success of
its research and development programs in 2017 and beyond, the
Company's planned operations, the value of the additional patents
and intellectual property; the Company's expectations related to
the applications of the patented technology; the Company's
expectations as to adequacy of its existing capital resources; the
design, timing, success of planned clinical trial programs; 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 REOLYSIN as a cancer
treatment, 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, 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.
SOURCE Oncolytics Biotech Inc.