-- 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.