CALGARY, Dec. 22, 2014 /PRNewswire/ - Oncolytics Biotech
Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it
has submitted applications for Orphan Designation to the European
Medicines Agency ("EMA") for REOLYSIN® for the treatment
of pancreatic and ovarian cancers.
"This is the second jurisdiction in which we have elected to
file for Orphan Designation," said Dr. Brad
Thompson, President and CEO of Oncolytics. "The EMA serves
all 28 member countries of the EU and securing Orphan Designation
would help support the future development of REOLYSIN®
in the region."
The EMA grants Orphan Designation to medicines intended to
treat, prevent or diagnose life threatening and debilitating
disease, with a prevalence no greater than five in 10,000 in the
EU, and where no satisfactory method of treatment, prevention or
diagnosis exists, unless the proposed medicine offers a significant
benefit to those with the condition. Following Orphan Designation,
sponsors can access a number of incentives including protocol
assistance, market exclusivity for a ten-year period following
approval and potential fee reductions. The receipt of Orphan
Designation does not change the regulatory requirements or process
for obtaining marketing approval. For more information, please
visit:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp.
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.
About Pancreatic Cancer
Pancreatic cancer affects
approximately 45,300 patients at any given time in the European
Union and has a prevalence of approximately 0.88 per 10,000.
About Ovarian Cancer
Ovarian cancer affects
approximately 150,000 women at any given time in the European Union
and has a prevalence of approximately 3 per 10,000.
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 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.