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 December
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
NUMBER |
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DESCRIPTION |
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| 99.1 |
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News
Release Dated December 2, 2014 - Oncolytics Biotech® Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for Pancreatic
and Ovarian Cancers |
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:
December 2, 2014 |
By: |
/s/ Kirk Look |
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Kirk Look |
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Chief Financial Officer |
Exhibit 99.1
Oncolytics Biotech® Inc. Announces Filing for Orphan Drug Designation
with the U.S. FDA for Pancreatic and Ovarian Cancers
CALGARY, Dec. 2, 2014 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC, NASDAQ:ONCY) today announced that it has submitted applications for Orphan Drug Designation to the U.S. Food and Drug
Administration ("FDA") for REOLYSIN® for the treatment of pancreatic and ovarian cancers.
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.
REOLYSIN® is Oncolytics' proprietary isolate of the reovirus.
Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions
of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway
mutations and/or over-expressions.
"Many patients with either pancreatic or ovarian cancer are not diagnosed
until after their disease has progressed to its later stages, which reduces their survival outcomes," said Dr. Brad Thompson,
President and CEO of Oncolytics. "The development of more targeted treatment options, in this case an agent targeting cancers
with Ras pathway defects, will allow patients to access the most suitable treatment for their specific case."
About Pancreatic Cancer
The American Cancer Society estimates that 46,420 Americans will be diagnosed with pancreatic cancer and an estimated 39,590 Americans
are expected to die from the disease in 2014. Approximately 44,539 patients are affected with pancreatic cancer at any time in
the U.S. The prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year
survival rate for all stages combined is approximately six percent.
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 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-DEC-14