CALGARY, Feb. 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 Orphan
Drug Designation for its lead product candidate,
REOLYSIN®, for the treatment of pancreatic cancer.
"This is the second indication for which we have received Orphan
Drug Designation in the United
States," said Dr. Brad
Thompson, President and CEO of Oncolytics. "The prognosis
for pancreatic cancer is typically poor, and it is critical to
expand the range of treatment options available to these
patients."
REOLYSIN® is Oncolytics' proprietary isolate of the
reovirus. Its primary mode of activity is to infect and selectively
target tumours with activating Ras pathway mutations and/or
over-expressions of Ras pathway elements including, amongst others,
EGFR, BRAF and KRAS. Up to 70% of pancreatic cancers have
activating Ras pathway mutations and/or over-expressions.
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 FDA has also granted an Orphan Drug Designation for the use
of REOLYSIN® for the treatment of ovarian cancer.
About Pancreatic Cancer
The American Cancer Society
estimates that 48,960 Americans will be diagnosed with pancreatic
cancer and an estimated 40,560 Americans will die from the disease
in 2015. Approximately 44,539 patients are affected with pancreatic
cancer at any time in the United
States. The prognosis for patients diagnosed with pancreatic
cancer, regardless of stage, is generally poor; the relative
five-year survival rate for all stages combined is approximately
seven 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®, 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.