Full Press Release Details
Oncolytics Biotech Inc.'s REOLYSIN More than
Doubles Overall Survival in Patients with Mutated p53 Metastatic Breast Cancer
CALGARY, April 5, 2017 /CNW/ - Oncolytics Biotech
Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced data demonstrating a statistically significant (p=0.03)
overall survival (OS) benefit for patients with mutated p53 metastatic breast cancer, when treated with REOLYSIN ,
an immuno-oncology viral agent, in combination with paclitaxel. Results from IND 213, an open-label, randomized,
phase 2 study were presented at the Annual Meeting of the American Association of Cancer Research (AACR), April 1-5, 2017 in Washington,
"Mutations of the p53 tumor suppressor gene play an increasingly
challenging role throughout the life cycle of cancer," said Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics.
"As breast cancer progresses clinically, p53 mutations become more prominent and negatively impact therapeutic efficacy and
overall survival. These data provide evidence that combining REOLYSIN with paclitaxel may improve survival for this difficult-to-treat,
well characterized, patient population."
The open-label, randomized, phase 2 study enrolled 74 patients
with metastatic breast cancer, 82 percent (61 patients) of whom presented with p53 mutated tumors. The results show patients with
mutated p53 metastatic breast cancer that were treated with REOLYSIN in combination with paclitaxel (n=30) had
a median OS of 20.9 months versus 10.4 months (n=31) in patients treated only with paclitaxel. The study was designed and
conducted by the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer Institute of Canada - NCIC).
"The observed survival benefit is very exciting and reinforces
the effectiveness and tolerability of REOLYSIN in patients with mutated p53 metastatic breast cancer, while demonstrating its potential
utility in earlier lines of treatment for this difficult-to-treat, high-risk group of patients," said Dr. Andres Gutierrez,
Chief Medical Officer of Oncolytics. "These data indicate overall survival is more than doubled for patients when treatment
with REOLYSIN is added to the standard of care and highlight key considerations for the design and execution of a registration
study in breast cancer. Our immediate next steps include seeking advice from key opinion leaders and regulators on refining our
go-forward regulatory strategy and registration pathway."
In the abstract for the poster, the CCTG had previously reported
that in the intention-to-treat patient population there was an improvement in median OS (secondary endpoint) from 10.4 months on
the control arm to 17.4 months on the test arm (Hazard ratio 0.65, 80% CI 0.46-0.91, p=0.1) meeting the pre-specified significance
threshold with powering of 90 percent. Consistent with REOLYSIN acting as an immune therapy agent, there was no meaningful improvement
in either progression free survival (the primary endpoint), or response rate (secondary endpoint). With this overall survival data
and the additional data from the p53 patient group, the company has commenced the planning of a registration study in metastatic
breast cancer with overall survival as the primary endpoint.
The poster, authored by Bernstein et al, "A Randomized
(RCT) Phase II Study of Oncolytic Reovirus (Pelareorep) plus Standard Weekly Paclitaxel (P) as Therapy for Metastatic Breast Cancer
(mBC)" will be available on the Oncolytics website at: http://www.oncolyticsbiotech.com/for-investors/presentations.
The National Cancer institute reported 246,660 new cases of breast cancer diagnosed in the United States and 40,450 deaths from
the disease in 2016.
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 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward-looking statements, including the Company's expectations related to the Phase 2 clinical trial in
breast cancer, future trials in this indication, and the Company's belief as to the potential of REOLYSIN as a cancer therapeutic,
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 tolerability of REOLYSIN
outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully
commercialize REOLYSIN, uncertainties related to the research, development and manufacturing of pharmaceuticals, changes in technology,
general changes to the economic environment and uncertainties related to the regulatory process. 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 should consider statements that include the words "believes", "expects",
"anticipates", "intends", "estimates", "plans", "projects", "should",
or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. 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.
To view the original version on PR Newswire, visit: http://www.newswire.ca/en/releases/archive/April2017/05/c5694.html
For further information: Oncolytics Investor & Media Contact:
Oncolytics Biotech Inc., Michael Moore, Vice President, Investor Relations & Corporate Communications, 858-886-7813, mmoore@oncolytics.ca;
AXON Media Contact: Marian Cutler, 914-701-0100 ext. 5361, mcutler@axon-com.com
CO: Oncolytics Biotech Inc.
CNW 07:00e 05-APR-17