Full Press Release Details
Oncolytics Biotech Inc.'s REOLYSIN Provides
Statistically Significant Improvement in Overall Survival in Canadian Cancer Trials Group Sponsored Randomized Phase 2 Study in
Metastatic Breast Cancer
CALGARY, March 31, 2017 /CNW/ - Oncolytics Biotech
Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) today announced the presentation of positive overall survival data from
an open-label, randomized, Phase 2 study designed by the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer
Institute of Canada - NCIC). The 74-patient study, powered to 90 percent, assesses the therapeutic combination of intravenously-administered
REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic
breast cancer. Data from the study (IND 213), will be presented during the American Academy of Cancer Research (AACR) Annual
Meeting, April 1-5, in Washington, DC.
The abstract reports that in the intention-to-treat (ITT)
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 level for the 90 percent powered
study. 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). The Company is now planning a registration study in metastatic
breast cancer with overall survival as the primary endpoint.
"This is the first controlled, randomized study
where the systemic administration of an immuno-oncology viral agent (REOLYSIN), was well tolerated and had a significant
impact on the overall survival of relapsed metastatic breast cancer patients when used in combination with paclitaxel," said
Dr. Karen Gelmon, Head, Investigational Drug Program, Experimental Therapeutics, Department of Medical Oncology, British Columbia
"There is an emerging pattern, from this and other studies
with REOLYSIN, where patients obtain significant benefit in overall survival, despite limited impact on response rates and/or progression-free
survival," said Dr. Andres Gutierrez, Chief Medical Officer of Oncolytics. "This is a well-established pattern for other
immunotherapies, like checkpoint inhibitors, which have been approved on an overall survival primary endpoint in melanoma, NSCLC
and head and neck cancers. These phase 2 data also support the established mode of activity of REOLYSIN where selective cell
lysis of permissive cancer cells is followed by an anti-tumor immune response, which may be responsible for the meaningful survival
benefit for patients. Taking into account the specific findings from this study, we continue to believe that REOLYSIN is not solely
an oncolytic agent, but has key attributes of an immuno-oncology agent as well."
The abstract, 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)" is now available on the AACR website. CCTG will be making a poster presentation, #8466, at the AACR Annual
Meeting, on Tuesday Apr 4, 2017 from 1:00 PM - 5:00 PM, in Washington, DC.
Oncolytics would like to thank the patients that participated
in this study, the CCTG and all the physicians and nurses involved.
The American Cancer Society estimates there will be 255,180 new cases of breast cancer diagnosed in the United States and 41,070
deaths from the disease in 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 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/March2017/31/c4482.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 16:23e 31-MAR-17