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:
http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.
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.