Study met its primary endpoint in reducing
annualized relapse rate (ARR) and measured secondary endpoints,
compared to interferon (IFN) β-1a (Avonex®)
Safety and tolerability consistent with phase
II studies
Confirmatory phase III RADIANCE trial data
expected in Q2 of 2017
Celgene Corporation (NASDAQ: CELG) today announced that its
phase III SUNBEAM trial, evaluating the efficacy and safety of
ozanimod, an investigational oral, selective S1P 1 and 5 receptor
modulator, in patients with relapsing multiple sclerosis (RMS), met
the primary endpoint in reducing annualized relapse rate (ARR),
compared to weekly interferon (IFN) β-1a (Avonex®).
SUNBEAM evaluated two orally administered treatment doses (0.5
mg and 1 mg) of ozanimod, with patients treated for at least one
year. The randomized phase III trial enrolled 1,346 RMS patients in
20 countries.
Top-line data show that both the ozanimod 1 mg and 0.5 mg
treatment arms demonstrated statistically significant and
clinically meaningful improvements compared to Avonex® for the
primary endpoint of ARR and the measured secondary endpoints of the
number of gadolinium-enhancing MRI lesions and the number of new or
enlarging T2 MRI lesions at month 12. As agreed to in the Special
Protocol Assessment (SPA) with the U.S. Food and Drug
Administration, a pre-specified analysis on the time to onset of
disability progression will be conducted using pooled results from
both the SUNBEAM and RADIANCE phase III trials.
The overall safety and tolerability profile was consistent with
results from previously reported phase II RMS (RADIANCE) and phase
II ulcerative colitis (TOUCHSTONE) trials.
“The safety and efficacy results from SUNBEAM are consistent
with the long-term results from the phase II trial (RADIANCE).
These data add to the growing body of evidence supporting the use
of ozanimod as a disease modifying therapy for relapsing forms of
multiple sclerosis,” said Bruce Cree, Associate Professor of
Neurology, Multiple Sclerosis Center, Department of Neurology,
University of California San Francisco. “We look forward to the
continued study of ozanimod as well as presentation of the full
results of the phase III trial at an upcoming international
scientific meeting.”
“People living with multiple sclerosis need additional therapies
and we are pleased that oral ozanimod showed meaningful
improvements across primary and measured secondary endpoints in
this study,” said Scott Smith, President of Celgene Inflammation
and Immunology. “We look forward to data from the confirmatory
phase III RADIANCE trial in the second quarter as we advance toward
planned regulatory submissions by year-end.”
About SUNBEAM
SUNBEAM is a phase III multicenter, randomized, double-blind,
double-dummy, active-controlled study assessing the efficacy,
safety and tolerability of two orally administered doses of
ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon
beta-1a (Avonex®) over a minimum of a 12-month treatment period.
The study included 1,346 RMS patients across 152 sites in 20
countries.
The primary endpoint of the active comparator trial is ARR
during the treatment period. The measured secondary endpoints are:
the number of new or enlarging hyperintense T2-weighted brain MRI
lesions over 12 months and the number of GdE brain MRI lesions at
month 12. The time to onset of disability progression as defined by
a sustained worsening in EDSS of 1.0 points or more, confirmed
after 3 months and 6 months, will be analyzed as part of a
pre-specified pooled analysis of SUNBEAM and RADIANCE data.
About Ozanimod
Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1
(S1PR1) and 5 (S1PR5) receptor modulator in development for
immune-inflammatory indications including relapsing multiple
sclerosis, ulcerative colitis and Crohn’s disease. Selective
binding with S1PR1 receptors is believed to inhibit a specific sub
set of activated lymphocytes from migrating to sites of
inflammation. The result is a reduction of circulating T and B
lymphocytes that leads to anti-inflammatory activity. Importantly,
immune surveillance is maintained.
Selective binding with S1PR5 receptors is believed to activate
specific cells within the CNS. This has the potential to enhance
remyelination and prevent synaptic defects. Ultimately,
neurological damage may be prevented.
Ozanimod is an investigational compound that is not approved for
any use in any country.
About Multiple Sclerosis
Multiple sclerosis is a disease in which the immune system
attacks the protective myelin sheath that covers the nerves. The
myelin damage disrupts communication between the brain and the rest
of the body. Ultimately, the nerves themselves may deteriorate — a
process that's currently irreversible. Signs and symptoms vary
widely, depending on the amount of damage and the nerves affected.
Some people with severe multiple sclerosis may lose the ability to
walk independently, while others experience long periods of
remission during which they develop no new symptoms. Multiple
sclerosis affects approximately 400,000 people in the U.S. and
approximately 2.5 million people worldwide.
RMS is characterized by clearly defined attacks of worsening
neurologic function. These attacks — often called relapses,
flare-ups or exacerbations — are followed by partial or complete
recovery periods (remissions), during which symptoms improve
partially or completely, and there is no apparent progression of
disease. RMS is the most common disease course at the time of
diagnosis. Approximately 85 percent of people are initially
diagnosed with relapsing multiple sclerosis, compared with 10-15
percent with progressive forms of the disease.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. For more
information, please visit www.celgene.com. Follow Celgene on
Social Media: @Celgene, Pinterest, LinkedIn, Facebook and
YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
“expects,” “anticipates,” “believes,” “intends,” “estimates,”
“plans,” “will,” “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Celgene Corporation undertakes no obligation to update any
forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond Celgene’s
control. Actual results or outcomes may differ materially from
those implied by the forward-looking statements as a result of the
impact of a number of factors, many of which are discussed in more
detail in Celgene’s Annual Report on Form 10-K and other reports
filed with the U.S. Securities and Exchange Commission.
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For inquiries:Celgene CorporationInvestors:Patrick E. Flanigan
IIICorporate Vice President, Investor
Relations908-673-9969orMedia:Catherine CantoneSenior Director,
Corporate Communications908-897-4256
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