Full Press Release Details
Oncolytics Biotech Inc. Announces Receipt of Orphan Drug
Designation from the U.S. FDA for Primary Peritoneal Cancer
CALGARY, March 3, 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 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
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 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.
For further information: TMX Equicom: Nick Hurst, 300 5th
Ave. SW, 10th Floor, Calgary, Alberta, T2P 3C4, Tel: 403.218.2835, Fax: 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 03-MAR-15