CALGARY, April 17, 2015 /PRNewswire/ - Oncolytics
Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY), a
clinical-stage biotechnology company focused on the development of
oncolytic viruses as potential cancer therapeutics, today announced
that the U.S. Food and Drug Administration (FDA) has granted an
Orphan Drug Designation (ODD) for its lead product candidate,
REOLYSIN®, for the treatment of malignant glioma.
The Company applied for an ODD for pediatric high grade
gliomas (HGG), however the FDA granted an ODD for the broader
indication of malignant glioma in patients of all ages. In
three previous brain cancer studies including gliomas,
REOLYSIN® has been shown to infect a variety of brain
tumors when delivered intravenously.
"The focus of our Orphan Drug submissions has been on difficult
to treat cancers where patients have few effective treatment
options," said Dr. Brad Thompson,
President and CEO of Oncolytics. "Pediatric patients with high
grade gliomas have particularly poor expected outcomes. We believe
these patients, along with the adult population affected by
malignant gliomas, would benefit from having additional treatment
options."
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.
According to the Central Brain Tumor Registry of the United States (CBTRUS), in 2015, an
estimated 68,470 new cases of primary malignant and non-malignant
brain and central nervous system tumors will be diagnosed of which
23,180 estimated new cases will be primary malignant tumors and
4,620 estimated new cases will be diagnosed in pediatric and
adolescent patients. The CBTRUS estimates that the broad
category glioma represents approximately 80% of malignant tumors
and in patients between zero and 19 years of age, the overall total
incidence of HGG (including anaplastic astrocytoma, anaplastic
oligodendroglioma, glioblastoma, mixed glioma, and malignant
glioma) is approximately 0.8 per 100,000.
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®, 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.