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 September 25, 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.
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in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
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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
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organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s
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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 September 25, 2015 - Oncolytics Biotech® Inc. Collaborators Present Data from Clinical Study in Multiple Myeloma |
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:
September 25, 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 Data from Clinical Study in Multiple Myeloma
-- All Evaluable Patients
to Date See Evidence of an Objective Response; Treatment Combination Associated with Statistically Significant Upregulation of
PD-L1--
CALGARY, Sept. 25, 2015 /CNW/ - Oncolytics
Biotech® Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) today announced that Dr. D.W. Sborov and colleagues
made a poster presentation at the 15th International Myeloma Workshop (IMW). The poster presentation, entitled "Combination
Carfilzomib and the Viral Oncolytic Agent REOLYSIN® in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating
Viral Proliferation," discloses initial findings from a pilot study (NCI-9603) in patients with relapsed or refractory multiple
myeloma treated using the combination of carfilzomib and REOLYSIN®. The IMW runs from September 23rd
to 26th in Rome, Italy.
Highlights of the data presented include:
- 100% of patients (8 of 8) experienced an objective response as measured
by changes in blood monoclonal protein. Of these, 2 patients had a very good partial response (VGPR), 3 patients had a partial
response (PR) and 3 patients had a minor response (MR);
- Only one patient has progressed to date and five of eight remain
on study;
- The combination of carfilzomib and REOLYSIN® produced
a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death; and
- The treatment combination was associated with an increased infiltration
of CD8+ T-cells and the significant (p=0.005) upregulation of PD-L1, suggesting that the addition of a PD-1 or PD-L1 inhibitor
may further optimize the treatment regimen.
"These findings demonstrate that the combination
of carfilzomib and REOLYSIN® shows promise in hematological malignancies like multiple myeloma and provide compelling
evidence that such drug combinations promote viral replication and cancer cell death," said Dr. Matt Coffey, Chief Operating
Officer of Oncolytics. "Based on these results, we intend to move into randomized studies in this indication."
The investigators noted that this is the first
time a REOLYSIN®-based combination has been tested in relapsed multiple myeloma patients. A previous single-agent
study conducted by the collaborators in this patient population showed that REOLYSIN® was well tolerated. The collaborators
and others were noted to have conducted preclinical investigations that demonstrated that the combination of REOLYSIN®
and carfilzomib synergistically increased the killing of multiple myeloma cells. This provided the clinical rationale for this
study. In this study, the combination of carfilzomib and REOLYSIN® produced a significant (p=0.005) increase in
caspase-3, a marker associated with apoptotic cell death. The researchers also determined that the combination of REOLYSIN®
and carfilzomib increases infiltration of CD8+ T-cells and significantly (p=0.005) upregulates PD-L1. The investigators concluded
that these findings necessitate continued investigation, and suggest that the addition of a PD-1 or PD-L1 inhibitor may further
optimize the REOLYSIN® and carfilzomib regimen.
"To this point, multiple myeloma has not
responded to checkpoint inhibitor therapy," said Dr. Brad Thompson, President and CEO of Oncolytics. "The combination
of REOLYSIN® and carfilzomib upregulates PD-L1 and increases infiltration of CD8+ T-cells, which may make the tumor
sensitive to anti-PD-L1 therapy. The follow-on randomized study we are currently planning is expected to have a patient group treated
with the combination of REOLYSIN®, a standard of care chemotherapy, and a checkpoint inhibitor, as well as a patient
group receiving REOLYSIN® and a standard of care chemotherapy."
NCI-9603 is a U.S. National Cancer Institute
sponsored single-arm, open-label study of intravenously administered REOLYSIN® with dexamethasone and carfilzomib
to patients with relapsed or refractory multiple myeloma. Patients receive treatment on days 1, 2, 8, 9, 15 and 16 of a 28-day
cycle, to be repeated in the absence of disease progression or unacceptable toxicity. Approximately 12 patients will be enrolled
in the study. The primary outcomes include measuring reovirus replication, safety, and tolerability. Secondary outcomes include
examining objective response, duration of response, clinical benefit, progression-free survival, and time to progression. Other
outcomes will include the measurement of immunologic correlative markers.
A copy of the poster will be available on the
Oncolytics website at: http://www.oncolyticsbiotech.com/for-investors/presentations.
About Multiple Myeloma
Multiple Myeloma is a cancer of the plasma cells and the second most common hematological malignancy. The American Cancer Society
estimates there will be 26,850 new cases diagnosed in the United States and 11,240 deaths from the disease in 2015.
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 pilot single-arm
clinical trial in multiple myeloma, 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: NATIONAL Equicom, Nick Hurst, 800
6th Ave. SW, Suite 1600, Calgary, Alberta T2P 3G3, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@national.ca; NATIONAL Equicom,
Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@national.ca; 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 25-SEP-15