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 May, 2015
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
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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 May 19, 2015 - Oncolytics Biotech® Inc. Announces Phase 1 Study in Pediatric Patients with Brain Tumors |
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:
May 19, 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 Phase 1 Study in Pediatric
Patients with Brain Tumors
CALGARY, May 19, 2015 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC, NASDAQ:ONCY) today announced that following submission to the U.S. Food and Drug Administration ("FDA")
for review, the Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication
Competent Reovirus (REOLYSIN®) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain
Tumors" is now active. The study sponsor is Mayo Clinic based in Rochester, Minnesota, and the Study Chair is Dr. Richard
Bram of Mayo Clinic.
"This is the first time we have been able to assess this
treatment combination in patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "Pediatric patients with
high grade primary brain tumors have few, if any, treatment options so we are eager to determine if this regimen can make a difference
for a group with poor survival outcomes."
The study is an open-label Phase I trial to clarify the safety,
and determine possible efficacy, of GM-CSF given prior to administration of intravenous REOLYSIN® for children with
malignant high grade brain tumors. GM-CSF will be administered on days one and two of each cycle with REOLYSIN®
administered on days three, four and five. Cycles will be given every 28 days for up to 12 cycles if patients remain without evidence
of tumor progression and without intolerable toxicity. The primary outcome for the nine to 18 patients of the Phase 1 study
will be safety and tolerability. Secondary goals include median progression free and overall survival in this patient population.
Eligible patients include those between the ages of 10 and
21 with histologically confirmed high grade (grade 3 or 4) primary brain tumor either classified as a glioma (including astrocytoma,
anaplastic oligodendroglioma and glioblastoma multiforme), medulloblastoma, atypical teratoid/rhabdoid tumor or primitive neuroectodermal
tumor. Patients must have no known curative therapy available and can have had up to two chemotherapy regimens for the brain tumor
previously.
Oncolytics has conducted three previous clinical studies in
adults with brain cancers including gliomas, and has found that REOLYSIN® can infect a variety of brain tumors when
delivered intravenously. In April 2014, the Company announced the findings from a clinical study showing that intravenously delivered
REOLYSIN® can cross the blood brain barrier and a pre-clinical study in animals examining the synergies associated
with treatment with GM-CSF prior to administering REOLYSIN®. The Company has received Orphan Drug Designation from
the FDA for the use of REOLYSIN® in the treatment of malignant gliomas.
According to the US Central Brain Tumor Registry an estimated
4,620 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed in pediatric and
adolescent patients in 2015. In patients between zero and 19 years old, the overall total incidence of HGG (including anaplastic
astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is approximately 0.8 per 100,000.
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 study in pediatric patients with relapsed or refractory
brain tumors, 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 19-MAY-15