Full Press Release Details
Oncolytics Biotech Inc. Announces Filing for Orphan Drug Designation
with the U.S. FDA for Gastric Cancer
CALGARY, April 7, 2015 /CNW/ - Oncolytics Biotech
Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has submitted an application for Orphan Drug Designation
to the U.S. Food and Drug Administration ("FDA") for REOLYSIN for the treatment of gastric cancer.
"Patients diagnosed with later stage gastric cancer generally have
very poor prognoses," said Dr. Brad Thompson, President and CEO of Oncolytics. "As a result, gastric cancer is a serious
issue both in the United States and other countries around the world including Japan and Korea where incidence rates are higher."
The FDA grants Orphan Drug Designation status to products that treat rare
diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer
than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives,
including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential
tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt
of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For
more information, please visit:
The American Cancer Society estimates that 24,590 Americans will be diagnosed
with gastric (stomach) cancer and an estimated 10,720 Americans are expected to die from the disease in 2015. The relative five-year
survival rate for all stages combined is approximately 28 percent.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.
Oncolytics' clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN ,
its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements within the meaning
of the U.S. Securities Act of 1933, as amended, and U.S. Securities Exchange Act of 1934, as amended, and forward-looking information
within the meaning of Canadian securities laws. Statements, other than statements of historical facts, included in this press release
that address activities, events or developments that Oncolytics expects or anticipates will or may occur in the future, including
such things as, the Company's expectations related to the granting of Orphan Drug Designation for REOLYSIN , future
work in gastric cancer, the Company's belief as to the potential of REOLYSIN as a cancer therapeutic, and
other such matters are forward-looking statements and forward-looking information and 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 and forward-looking
information. Such risks and uncertainties include, among others, risks related to the statistical sufficiency of patient enrollment
numbers in separate patient groups, 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 and development of pharmaceuticals 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 and forward-looking information. Investors are cautioned
against placing undue reliance on forward-looking statements and forward-looking information. The Company does not undertake to
update these forward-looking statements and forward-looking information, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.
For further information: TMX Equicom, Nick Hurst, 300 5th Ave. SW, 10th
Floor, Calgary, Alberta T2P 3C4, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@tmxequicom.com; TMX Equicom, Michael Moore, San Diego,
CA, Tel: 858.886.7813, mmoore@tmxequicom.com; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor, New York, NY 10018,
Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com
CO: Oncolytics Biotech Inc.
CNW 06:30e 07-APR-15