Full Press Release Details
Oncolytics Biotech Inc. Announces Receipt of Orphan Drug
Designation from the U.S. FDA for Ovarian Cancer
CALGARY, Feb. 11, 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 ovarian cancer.
"This is an important regulatory
milestone for Oncolytics and will provide us with a number of benefits as we advance the development and commercialization process
for REOLYSIN ," said Dr. Brad Thompson, President and CEO of Oncolytics. "Ovarian cancer is a devastating
disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."
Oncolytics has supported two sponsored
clinical studies assessing REOLYSIN in the treatment of ovarian cancer. 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:
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
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
SOURCE Oncolytics Biotech Inc.
For further information: TMX Equicom, Nick Hurst, 300 5th
Ave. SW, 10th Floor, Calgary, Alberta T2P 3C4, Tel: 403.218.2835Fax: 403.218.2830, nhurst@tmxequicom.com; TMX Equicom, Michael
Moore, San Diego, CA, Tel: 858.886.7813, mmoore@tmxequicom.com; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor,
New York, NY 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com
CO: Oncolytics Biotech Inc.
CNW 06:30e 11-FEB-15