CALGARY, March 2, 2015 /CNW/ - 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 cancer of the fallopian
tube. 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.
"The FDA's recognition of ovarian and fallopian tube cancers as
distinctly separate indications paves the way for a more targeted
approach to the treatment of gynecological cancers," said Dr.
Brad Thompson, President and CEO of
Oncolytics. "We are pleased to have secured our third Orphan Drug
Designation in the United States
and look forward to continuing our development and
commercialization program for REOLYSIN®."
Oncolytics has supported two sponsored clinical studies
assessing REOLYSIN® in the treatment of cancers of the
fallopian tube. 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 Fallopian Tube Cancer
The incidence rate of
fallopian tube cancers is estimated to be 0.37 per 100,000 women.
Approximately 15,750 patients are affected with fallopian tube
cancer at any time in the United
States. The median survival of women in the U.S. with
fallopian tube cancers is 58 months, or just under five 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.