-- Preliminary data suggest evidence of activity
and that the treatment combination was well tolerated --
CALGARY, Dec. 6, 2016 /PRNewswire/ - Oncolytics
Biotech® Inc. ("Oncolytics" or the "Company")
(TSX:ONC) (OTCQX:ONCYF) today announced that Dr. Kevin Kelly and colleagues made a poster
presentation at the 58th American Society of Hematology
("ASH") Annual Meeting. The poster presentation, titled "Oncolytic
Reovirus Immune Priming: A Phase Ib Study of REOLYSIN®
with Bortezomib and Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma," provides initial findings
from the Company's REO 019 Phase Ib trial. The ASH Annual Meeting
runs from December 3rd to
6th in San Diego,
CA.
The study is a two-stage open-label Phase Ib trial of adult
patients with relapsed or refractory multiple myeloma following at
least one line of therapy. This study was designed to evaluate
tolerability, to confirm that the addition of REOLYSIN®
to bortezomib increases endoplasmic reticulum stress and death of
myeloma cells (as shown in preclinical models) and to document
pharmacodynamic effects as part of the characterization of the
mechanism(s) of action of REOLYSIN® in multiple myeloma.
Kevin Kelly, M.D., Ph.D. of the Keck
School of Medicine of the University of
Southern California (USC), is
the principal investigator.
"The combination of REOLYSIN®, bortezomib and
dexamethasone was well-tolerated in these heavily pre-treated
patients, even in those who had been previously exposed to
bortezomib," said Dr. Kevin Kelly.
"Preliminary evidence of activity of this combination was
documented. It was also shown that the combination therapy induced
the apoptosis of myeloma cells and stimulated the immune system,
highlighted by improved cytotoxic T cell infiltration and
activation of checkpoint inhibitors (IDO, PD-L1) in the tumor."
The dose escalation study tested three doses ranging from 3 to
9x1010 TCID50 on days 1, 2, 8, 9, 15 and 16,
with 40 mg dexamethasone and 1.5 mg/m2 bortezomib on days 1, 8, and
15. Cycles were repeated every 28 days. A maximum tolerated dose
was not defined because there were no dose-limiting toxicities in
the first two cohorts. Cohort 3 is still enrolling patients. The
combination was well tolerated and most treatment emergent
toxicities were transient and easily managed with supportive care.
The most common treatment related toxicities were grade 1 diarrhea,
grade 1 fatigue, grade 1 flu-like symptoms and grade 1
headache.
Three patients completed 1 cycle of treatment only, 2 completed
3 cycles, 1 completed 4 cycles and 1 completed 7 cycles. Two
patients remain on protocol (1 has completed 3 cycles (Cohort 3)
and the other 7 cycles (Cohort 2)). Six patients were evaluable for
response, 4 patients had stable disease lasting at least 1 cycle,
whereas 3 patients had progressive disease at the end of cycle
1.
"It is intriguing that this combination therapy with
REOLYSIN® induced an immune response with mainly
grade 1 level toxicity, which is consistent with what we have
observed in studies with other REOLYSIN®
combinations in solid tumors," said Dr. Matt Coffey, Interim President and CEO of
Oncolytics Biotech. "These data build on what we have observed in
previous studies in both multiple myeloma and solid tumours, and
further investigation is needed to evaluate if the immune
modulatory and anti-tumor activity of REOLYSIN® can
provide a therapeutic opportunity to patients with hematological
malignancies when combined with other targeted treatments including
immunotherapies."
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
30,330 new cases diagnosed in the United
States and 12,650 deaths from the disease in 2016.
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 1b 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.