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 July, 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): ☐
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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): ☐
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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
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Indicate by check mark whether by furnishing the information contained
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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 -
EXHIBIT
NUMBER |
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DESCRIPTION |
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99.1 |
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News
Release Dated July 6, 2015 - Oncolytics Biotech® Inc. Collaborators Present Final Data from REO 017 Clinical Study in Pancreatic Cancer |
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:
July 6, 2015 |
By: |
/s/ Kirk Look |
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Kirk Look |
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Chief Financial Officer |
Exhibit 99.1
Oncolytics Biotech® Inc. Collaborators Present Final Data from REO 017
Clinical Study in Pancreatic Cancer
--Report More Than Doubling in One-Year Survival and
Nearly Five-Fold Increase in Two-Year Survival as Compared to Historical Controls--
CALGARY, July 6, 2015 /CNW/ - Oncolytics Biotech®
Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) today announced that Dr. Devalingam Mahalingam of the Cancer Therapy and
Research Centre, University of Texas Health Science Centre San Antonio, made a poster presentation at the ESMO World Congress on
Gastrointestinal Cancer. The poster, titled "Oncolytic Virus Therapy in Pancreatic Cancer: Clinical Efficacy and Pharmacodynamic
Analysis of REOLYSIN® in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma,"
covers final results from the Company's REO 017 Phase 2 study.
"These data suggest that this drug combination can increase median
overall survival, as well as generate an approximate two-fold increase in one-year survival rates, and a five-fold increase in
two-year survival rates when compared to gemcitabine therapy alone as seen in historical data," said Dr. Matt Coffey, COO
of Oncolytics. "The observation of clear overall survival (OS) benefit combined with apparent limited impact on progression
free survival (PFS) is increasingly becoming characteristic of immune-based therapeutic treatments. We are incorporating this finding
into both our new and existing studies to ensure we follow OS where possible."
Highlights of the data presented include:
| · | A survival analysis for 33 patients showing a median progression free survival (PFS)
of four months and median overall survival (OS) of 10.2 months; |
| · | Data showing one- and two-year survival rates of 45% and 24%, respectively; and |
| · | An analysis demonstrating upregulation of immune checkpoint marker PD-L1 in post
treatment tumours suggesting the potential to combine oncolytic viral therapy with anti-PD-L1 inhibitors in future trials. |
A summary of the overall data compared to historical controls is shown
below:
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Treatment |
Number of
patients |
Median PFS
(months) |
Median OS
(months) |
1-year
survival (%) |
2-year
survival (%) |
Gemcitabine (ACCORD 11) (Conroy et al., 2011) |
171 |
3.3 |
6.8 |
20 |
2 |
Gemcitabine (MPACT) (Von Hoff et al., 2013; Goldstein et al., 2015) |
430 |
3.7 |
6.6 |
22 |
5 |
Gemcitabine/REOLYSIN® (REO 017) |
33 |
4.0 |
10.2 |
45 |
24 |
Of the 29 patients evaluable for clinical response, one patient had a
partial response (PR), 23 had stable disease (SD) and five had progressive disease as their best response. This translated into
a clinical benefit rate (CBR) (complete response (CR) + PR + SD) of 83%.
"This is the second cancer where we have confirmed that PD-L1 is
upregulated in target tumors following our collaborators initial observations of PD-L1 upregulation in glioblastoma," said
Dr. Brad Thompson, President and CEO of Oncolytics. "We are currently analyzing archived samples from other completed
studies and current samples from ongoing studies to determine if this is a common effect to most cancers. A systemic viral therapy
that generally led to upregulation of PD-L1 would allow increased use of anti PD-L1 drugs in cancers where there is insufficient
PD-L1 to make therapy possible."
REO 017 is a U.S. Phase 2, single-arm clinical trial using intravenous
administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in chemotherapy-naïve
patients with advanced or metastatic pancreatic cancer. Eligible patients were treated with gemcitabine at 800 mg/m2
on days 1 and 8, and REOLYSIN® at 1x1010 TCID50 administered IV on days 1, 2, 8 and 9 every
3 weeks. Tumor assessment was performed every two cycles. The trial enrolled 33 evaluable patients (34 total) using a one sample,
two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted. If three or more responses
were observed (defined as CR, PR, or SD for 12 weeks or more) among the 17 patients, the study would enroll an additional 16 patients
for a total of at least 33 evaluable patients. As previously disclosed, this initial endpoint was met after six evaluable
patients were enrolled. The primary objective of the trial was to determine the CBR of intravenous multiple doses of REOLYSIN® in
combination with gemcitabine in patients with advanced or metastatic pancreatic cancer. The secondary objectives were to determine
PFS, and to determine the safety and tolerability of REOLYSIN® when administered in combination with gemcitabine.
A copy of the poster presentation will be available on the Oncolytics
website at: http://www.oncolyticsbiotech.com/for-investors/presentations.
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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements, including the Company's expectations related to the Phase II single-arm clinical trial
in pancreatic cancer, future trials in this indication, and the Company's belief as to the potential of REOLYSIN®
as a cancer therapeutic, 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. Such risks and uncertainties include, among others, 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, development
and manufacturing of pharmaceuticals, changes in technology, general changes to the economic environment 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. Investors should
consider statements that include the words "believes", "expects", "anticipates", "intends",
"estimates", "plans", "projects", "should", or other expressions that are predictions of
or indicate future events or trends, to be uncertain and forward-looking. Investors are cautioned against placing undue reliance
on forward-looking statements. The Company does not undertake to update these forward-looking statements, 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 06-JUL-15