CALGARY, Dec. 2, 2014 /CNW/ - Oncolytics Biotech Inc.
("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has
submitted applications for Orphan Drug Designation to the U.S. Food
and Drug Administration ("FDA") for REOLYSIN® for the
treatment of pancreatic and ovarian cancers.
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.
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.
"Many patients with either pancreatic or ovarian cancer are not
diagnosed until after their disease has progressed to its later
stages, which reduces their survival outcomes," said Dr.
Brad Thompson, President and CEO of
Oncolytics. "The development of more targeted treatment options, in
this case an agent targeting cancers with Ras pathway defects, will
allow patients to access the most suitable treatment for their
specific case."
About Pancreatic Cancer
The American Cancer Society
estimates that 46,420 Americans will be diagnosed with pancreatic
cancer and an estimated 39,590 Americans are expected to die from
the disease in 2014. Approximately 44,539 patients are affected
with pancreatic cancer at any time in the U.S. 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 six percent.
About Ovarian Cancer
The American Cancer Society
estimates that 21,908 American women will be diagnosed with ovarian
cancer and an estimated 14,270 will die from the disease in 2014.
Approximately 193,203 patients are affected with ovarian cancer at
any time in the U.S. Ovarian cancer accounts for about 5% of all
cancer deaths among women. The prognosis for patients diagnosed
with ovarian cancer at the localized stage is good, with a
five-year survival rate of 92%; however, only about 15% of cases
are diagnosed at this stage. The relative 10-year survival rate for
all stages combined is approximately 35%.
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.