Additional randomized phase 2 data in
metastatic breast cancer demonstrates doubling of overall survival
in Hormone Receptor Positive (ER+PR+)/HER2- patients
Largest immuno-oncolytic virus safety
database reported to-date
demonstrates
REOLYSIN® is safe and
well-tolerated
CALGARY and SAN DIEGO, Sept. 11,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN®, a first-in-class,
systemically delivered immuno-oncolytic virus that activates the
innate and adaptive immune systems, today announced that two poster
presentations focused on REOLYSIN were presented on Sunday, September 10 at the European Society for
Medical Oncology (ESMO) 2017 Congress.
- 1193P, Pooled data analysis of the safety and tolerability
of intravenous Pelareorep in combination with chemotherapy in 500 +
cancer patients, Dr. Andres
Gutierrez, Oncolytics Biotech
"Our poster on pooled data outlines the largest safety database
available to date for an oncolytic virus and demonstrates that
REOLYSIN is safe and well tolerated when administered in
combination with chemotherapy," said Dr. Matt Coffey, President and CEO of Oncolytics
Biotech. "Regarding the metastatic breast cancer data presented
within this pooled safety data, further analysis of our phase two
study highlights a doubling of overall survival benefit for
patients with hormone receptor double-positive, HER2-negative
breast cancer – a major genetic subgroup – when treated with
REOLYSIN/paclitaxel combination treatment versus paclitaxel alone.
The poster demonstrates a strong safety profile and statistically
significant efficacy as we continue to advance towards regulatory
approval for REOLYSIN in this indication."
In the IND 213 randomized phase 2 study in metastatic breast
cancer, conducted by the Canadian Cancer Trials Group, HR+
(ER+/PR+) / HER2- patients (n=47) demonstrated that the test arm of
REOLYSIN/paclitaxel more than doubled median overall survival (OS)
from 10.8 months on the control arm (paclitaxel alone) to 21.8
months. The hazard ratio was 0.36 and p-value was 0.003. The
ITT (intent-to-treat) group (n=74, all genetic subtypes) improved
median OS from 10.4 months on the control arm to 17.4 months on the
test arm. The topline ITT data was initially announced at the
American Association for Cancer Research in April 2017, continues to mature and we are
hopeful that complete OS data is made available in the future.
Highlights of the pooled safety data study include:
- Adverse events reported most frequently by REOLYSIN-treated
patients were reversible Grade 1 and 2 events, including fever,
chills, fatigue and the gastrointestinal-related AEs of nausea,
vomiting, diarrhea.
- REOLYSIN did not modify or increase chemotherapy-induced
Grade 3 or 4 treatment-emergent adverse events (TEAEs).
- Certain serious TEAEs were more common in the
REOLYSIN-treated arms, however the incidence of serious AEs due to
febrile neutropenia and/or infection was similar in each
group.
Oncolytics recently attended an End-of-Phase 2 meeting with the
United States Food and Drug Administration (FDA), which addressed
registration pathways for REOLYSIN for the treatment of metastatic
breast cancer, the indication for which the FDA has granted Fast
Track designation. The Company will announce the outcome of this
meeting after receiving the formal minutes from the agency and
expects to announce the outcome of any filings coming as a result
of this meeting before the end of the year.
- 523P, 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), Dr. Sanjay Goel, Montefiore Medical Center, NY
Poster 523, presented by Dr. Sanjay
Goel of Montefiore Medical Center in New York, characterizes the mechanism of
pelareorep-mediated cell death. The phase 1 trial studied the
combination of REOLYSIN with irinotecan/ fluorouracil/ leucovorin/
bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic
colorectal cancer. The study found that REOLYSIN is safe and well
tolerated in combination with FOLFIRI/B, and suggests that REOLYSIN
compromises cancer cell integrity via a novel mechanism of
viral-mediated cytotoxicity.
About REOLYSIN
REOLYSIN® is a non-pathogenic,
proprietary isolate of the unmodified reovirus: a first-in-class
systemically 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, a systemically 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.