- Proposed phase 3 study design is found acceptable and can form
the basis of a Marketing Authorization Application (MAA)
- Feedback continues to support our focus on HR+/HER2- patients
that reported a statistically significant increase in median
overall survival by nearly doubling from 10.8 to 21.0 months
- EMA advice consistent with feedback received from FDA paving
the way for a global phase 3 study
CALGARY and SAN DIEGO, CA, Dec. 5,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN®, also known as pelareorep,
an intravenously delivered immuno-oncolytic virus that activates
the innate and adaptive immune systems to turn 'cold' tumors 'hot',
today announced that the company has received a favorable Final
Advice Letter from the European Medicines Agency (EMA). The Letter
refers to the proposed use of pelareorep in combination with
paclitaxel, for the treatment of hormone receptor positive, HER2
receptor negative (HR+/HER2-) metastatic breast cancer patients in
a pivotal phase 3 registration study and suggests that a single
400-patient study may be acceptable to form the basis of a
Marketing Authorization Application (MAA) in Europe.
"The EMA's feedback and Final Advice Letter are very much inline
with the feedback and advice we received from the FDA in September
and adds to the support we have for our proposed target patient
population of HR positive/HER2 negative metastatic breast cancer
patients for the registration study," said Dr. Matt Coffey, President and CEO of Oncolytics
Biotech. "Our statistically significant and clinically compelling
overall survival data, Fast Track designation and clear guidance
from the FDA and EMA allow us to focus on the completion of the
adaptive study design that will include approximately four hundred
patients with a pre-determined interim analysis at two hundred
patients. Furthermore, the EMA provided guidance that if the study
achieves its primary endpoint, it may form the basis of a Marketing
Authorization Application for commercialization in Europe. The
design of the study, feedback from both the FDA and EMA and our
recently announced partnership with Adlai Nortye will also drive
our ongoing 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 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/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;
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 and 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 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 of
REOLYSIN® as a cancer therapeutic; the
Corporation's proposed use of REOLYSIN in combination with
paclitaxel, for the treatment of hormone receptor positive, HER2
receptor negative (HR+/HER2-) metastatic breast cancer (mBC)
patients in a phase 3 registration study; the potential basis for
a marketing authorization application (MAA) in Europe; the Corporation's proposed target
patient population of HR positive/HER2 negative metastatic breast
cancer patients for the registration study; the proposed
characteristics for an adaptive study design; the Corporation's
plans for future partnering arrangements; the timing of release of
details of the Corporation's proposed phase 3 registration
study; the Company's plans regarding its first
registration study in metastatic breast cancer and studies in
combination with checkpoint inhibitors and IMiD therapies in solid
and hematological malignancies; 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.