SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of March
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrant’s name into
English)
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
(Address
of principal executive offices)
Indicate by check mark whether the registrant files or will file
annual reports under cover Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits
the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits
the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private
issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s
securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed
to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained
in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under
the Securities Exchange Act of 1934.
If “Yes” is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b): 82 -
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EXHIBIT
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DESCRIPTION |
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| 99.1 |
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News
Release Dated March 2, 2015 - Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Cancer of
the Fallopian Tube |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Oncolytics Biotech Inc.
(Registrant) |
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| Date:
March 2, 2015 |
By: |
/s/ Kirk Look |
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Kirk Look |
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Chief Financial Officer |
Exhibit 99.1
Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug
Designation from the U.S. FDA for Cancer of the Fallopian Tube
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.
%CIK: 0001129928
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 02-MAR-15