CALGARY and SAN DIEGO, Sept. 14,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN® (pelareorep), a
first-in-class, systemically delivered immuno-oncolytic virus that
activates the innate and adaptive immune systems, today announced
that the first patient has been treated in the Phase 1b trial MUK
eleven, studying REOLYSIN in combination with Celgene Corporation's
immunomodulatory drugs (IMiDs), Revlimid® or Imnovid® as a rescue
treatment in relapsing myeloma patients.
"This is an important trial for Oncolytics as it's the first to
discretely examine the innate immunity component of REOLYSIN's
mechanism of action," said Dr. Matt
Coffey, President and CEO of Oncolytics Biotech. "MUK
eleven and REO 024, our trial evaluating the induction of an
inflamed tumor phenotype of REOLYSIN in a combination with
Keytruda, collectively demonstrate our strategy to assess the
safety and efficacy of REOLYSIN in combination with
immunomodulatory and immuno-oncology drugs, the impact of these
combinations on the immune system and to explore new clinical
applications."
"We are pleased to have enrolled the first patient in MUK
eleven, a trial focused on a novel area of myeloma
research," said Dr. Simon Ridley,
Director of Research at Myeloma UK. "Our Clinical Trial Network is
focused on strategic, collaborative and innovative approaches to
delivering trials and treatments to patients and this pioneering
trial has the potential to offer a novel future treatment strategy
in myeloma."
MUK eleven is a first-of-its-kind immunotherapy trial
that aims to modulate the immune system to target myeloma. The
trial, run through the Myeloma UK Clinical Trial Network (CTN) in
collaboration with charity Myeloma UK, the University of Leeds and
Celgene, launched in March of this year and will recruit
approximately 44 patients across up to eight CTN centres in the UK.
MUK eleven will study REOLYSIN (pelareorep) in combination
with Celgene's Imnovid® (pomalidomide) or Revlimid® (lenalidomide)
in patients whose myeloma is progressing while being treated with
one of these IMiDs. In addition to assessing the safety and
tolerability of these combinations, the trial will investigate
whether the addition of REOLYSIN extends disease control in this
patient group.
MUK eleven is a dose escalation trial where dose limiting
toxicities (DLTs) will inform decisions to increase dose, and
patients being treated with pomalidomide will be evaluated
separately from those taking lenalidomide. Beginning at two CTN
centres, cohorts of two participants each will be treated with
REOLYSIN in combination with an IMiD. The first patient will
receive one 28-day treatment cycle and if no DLTs are experienced
at the end of the cycle, the second patient will begin treatment at
the same dose. Doses may be escalated once participants in each
cohort have completed the DLT monitoring period and will be
increased between cohorts until the occurrence of DLTs define the
maximum tolerated dose (MTD). Once the MTD has been identified with
no associated safety issues, 10 additional patients will be
enrolled at the MTD. Once a minimum of 12 patients in each IMiD
group have been treated, up to six additional trial sites may be
added to the trial. Based on this trial design, preliminary data
are expected to be available in the first quarter of 2018.
About REOLYSIN
REOLYSIN® is a non-pathogenic,
proprietary isolate of the unmodified reovirus. A
first-in-class systemically delivered immuno-oncolytic virus for
the treatment of solid tumors and hematological malignancies.
The compound induces selective tumor lysis and promotes an inflamed
tumor phenotype through innate and adaptive immune responses to
treat a variety of cancers.
About Oncolytics Biotech Inc.
Oncolytics is a
biotechnology company developing REOLYSIN, a systemically delivered
immuno-oncolytic virus. The compound induces selective tumor lysis
and promotes an inflamed tumor phenotype through innate and
adaptive immune responses to treat a variety of cancers.
Oncolytics' clinical development program emphasizes three pillars:
chemotherapy combinations to trigger selective tumor lysis;
immuno-therapy combinations to produce adaptive immune responses;
and immune modulator (IMiD) combinations to facilitate innate
immune responses. Oncolytics is currently planning its first
registration study in metastatic breast cancer, as well as studies
in combination with checkpoint inhibitors as well as targeted and
IMiD therapies in solid and hematological
malignancies. For further information about Oncolytics,
please visit: www.oncolyticsbiotech.com.
University of Leeds
The University of Leeds is one of
the largest higher education institutions in the UK, with more than
33,000 students from 147 different countries, and a member of the
Russell Group of research-intensive universities. We are a top 10
university for research and impact power in the UK, according to
the 2014 Research Excellence Framework and we are The Times and The
Sunday Times University of the Year 2017. Additionally, the
University has been awarded a gold rating by the Government's
Teaching Excellence Framework recognising its 'consistently
outstanding' teaching and learning provision. www.leeds.ac.uk
About Myeloma UK
Myeloma UK is the only organisation
in the UK dealing exclusively with myeloma - our ultimate goal is
to find a cure. We are dedicated to ensuring that patients get
access to the right treatment at the right time, and to improving
standards of treatment and care through research, education and
awareness raising. Our organisation also provides a range of
information and support services to patients, family and friends to
help deal with a diagnosis of myeloma. Myeloma UK receives no
Government funding and relies almost entirely on voluntary
donations and fundraising. For more information visit:
www.myeloma.org.uk.
This press release contains forward-looking statements,
within the meaning of Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements, including the
Company's belief as to the potential of REOLYSIN® as a
cancer therapeutic; the Company's expectations as to the success of
its research and development programs in 2017 and beyond, the
Company's planned operations, the value of the additional patents
and intellectual property; the Company's expectations related to
the applications of the patented technology; the Company's
expectations as to adequacy of its existing capital resources; the
design, timing, success of planned clinical trial programs; and
other statements related to anticipated developments in the
Company's business and technologies 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 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, uncertainties related to the regulatory process
and general changes to the economic environment. 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 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.