CALGARY, March 3, 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 primary peritoneal
cancers. The designation was granted on the basis of the Company's
December 2014 application for an
Orphan Drug Designation encompassing ovarian, fallopian tube and
primary peritoneal cancers which are generally treated as one
indication. On February 11,
2015, the Company announced that it had received Orphan Drug
Designation for ovarian cancer and for cancers of the fallopian
tube on March 2, 2015.
"This is the fourth indication for which we have received Orphan
Drug Designation in the United
States, and the third in a gynecological cancer indication,"
said Dr. Brad Thompson, President
and CEO of Oncolytics. "These Orphan Drug Designations are an
important step for Oncolytics' ongoing program to develop and
commercialize REOLYSIN® as a therapeutic for targeted
cancer patient populations."
Oncolytics has supported two sponsored clinical studies
assessing REOLYSIN® in the treatment of peritoneal
cancers. The first was a Phase 1/2 clinical trial (OSU-07022)
for patients with metastatic ovarian, peritoneal and fallopian tube
cancers using concurrent intravenous and intraperitoneal
administration of REOLYSIN® that provided evidence of
viral targeting and replication in peritoneal and ovarian cancer
cells. The second is an ongoing randomized Phase II trial
(GOG186H) of weekly paclitaxel versus weekly paclitaxel with
REOLYSIN® in patients with persistent or recurrent
ovarian, fallopian tube or primary peritoneal cancer. The second
trial completed enrollment in September
2014.
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.
About Primary Peritoneal Cancer
The incidence rate of
primary peritoneal cancers is estimated to be 0.68 per 100,000
women. Approximately 16,250 patients are affected with primary
peritoneal cancers at any time in the
United States. The median survival of women in the U.S. with
primary peritoneal cancers is 33 months, or just under three
years.
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.