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 22, 2014 - Oncolytics Biotech® Inc. Announces Filing for Orphan Designation with the EMA 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 22, 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 Designation
with the EMA for Pancreatic and Ovarian Cancers
CALGARY, Dec. 22, 2014 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC, NASDAQ:ONCY) today announced that it has submitted applications for Orphan Designation to the European Medicines Agency
("EMA") for REOLYSIN® for the treatment of pancreatic and ovarian cancers.
"This is the second jurisdiction in which we have elected
to file for Orphan Designation," said Dr. Brad Thompson, President and CEO of Oncolytics. "The EMA serves all 28 member
countries of the EU and securing Orphan Designation would help support the future development of REOLYSIN® in the
region."
The EMA grants Orphan Designation to medicines intended to
treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU,
and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant
benefit to those with the condition. Following Orphan Designation, sponsors can access a number of incentives including protocol
assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation
does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp.
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.
About Pancreatic Cancer
Pancreatic cancer affects approximately 45,300 patients at any given time in the European Union and has a prevalence of approximately
0.88 per 10,000.
About Ovarian Cancer
Ovarian cancer affects approximately 150,000 women at any given time in the European Union and has a prevalence of approximately
3 per 10,000.
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 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 22-DEC-14