Announces end-of-phase 2 meeting with the U.S.
Food and Drug Administration
CALGARY and SAN DIEGO, July 26,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced
that two abstracts describing both pooled safety and tolerability
data and the mechanism of REOLYSIN®, also known as
pelareorep®, have been selected for poster presentation
(display) at the European Society for Medical Oncology (ESMO) 2017
Congress. The abstracts will be published online on the ESMO
website at 3:05 ET on Wednesday,
August 30. The conference is taking place from September 8-12, 2017, in Madrid, Spain.
"The pooled analysis of patients treated with intravenous
pelareorep is the largest safety database available for this class
of agents in combination with chemotherapy," said Dr. Andres Gutierrez, Chief Medical Officer at
Oncolytics Biotech. "While our efficacy in metastatic breast cancer
announced earlier this year at AACR was captivating, the safety
component of pelareorep increases the benefit-risk ratio of the
therapy and supports its further development. We are
particularly excited to present these results as other
immuno-oncology agents in the same class have had limited or no
experience with systemic administration."
|
Publication
number:
|
1193P
|
|
Title:
|
Pooled data
analysis of the safety and tolerability of intravenous Pelareorep
in combination with chemotherapy in 500 + cancer
patients
|
|
Lead
Author:
|
Dr. Andres Gutierrez,
Oncolytics Biotech
|
|
|
|
Publication
number:
|
523P
|
|
Title:
|
Mechanism of
Pelareorep (Pel)-mediated cell death in a Phase I study in
combination with irinotecan/ fluorouracil/ leucovorin/ bevacizumab
(FOLFIRI/B) in patients with KRAS mutant metastatic colorectal
cancer (mCRC)
|
|
Lead
Author:
|
Dr. Sanjay Goel,
Montefiore Medical Center, NY
|
The Company also announced that it has been granted an
End-of-Phase 2 meeting with the United States Food and Drug
Administration (FDA), taking place in August
2017. The meeting will address registration pathways for
REOLYSIN® for the treatment of metastatic breast cancer,
the indication for which the FDA has granted Fast Track
designation. The Company expects to announce the outcome of this
meeting in the fourth quarter of 2017.
About Oncolytics Biotech Inc.
Oncolytics is a
biotechnology company developing REOLYSIN, an immuno-oncology
viral-agent, as a potential treatment for a variety of tumor types.
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
breast cancer, as well as studies in combination with checkpoint
inhibitors and IMiD/targeted 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.