Ozanimod highlighted in two oral presentations
detailing results from phase III SUNBEAM™ and RADIANCE™ trials in
RMS
Additional clinical and non-clinical poster
presentations will further characterize the profile of ozanimod
Celgene Corporation (NASDAQ:CELG) today announced that new data
on the efficacy and safety of ozanimod, a novel, oral, selective,
sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator,
in relapsing multiple sclerosis (RMS) were accepted for the
MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting, which is being
held in Paris, October 25-28, 2017.
“Our strong presence at this year’s meeting and the breadth of
data being presented on ozanimod highlight our commitment to
bringing forth ozanimod as a potential novel, oral therapeutic
option for people with multiple sclerosis,” said Terrie Curran,
President, Celgene Inflammation and Immunology.
Full results from the phase III SUNBEAM™ and RADIANCE™ Part B
studies evaluating two doses of oral ozanimod compared with Avonex®
(interferon beta-1a) (IFN) in people with RMS will be presented as
an oral and a late-breaking oral presentation, respectively.
Abstracts at a Glance
Oral Presentations:
Abstract #A-858-0029-00786; Friday, October 27, 2017, 2:52 p.m.
– 3:04 p.m. CET / 8:52 a.m. – 9:04 a.m. EDTOzanimod demonstrates
efficacy and safety in a phase 3 trial of relapsing multiple
sclerosis (SUNBEAM); G. ComiLocation: Parallel Session 13: Update
on relapsing-remitting MS management, Hall A
Abstract #A-858-0000-02736; Saturday, October 28, 2017, 9:42
a.m. – 9:54 a.m. CET / 3:42 a.m. – 3:54 a.m. EDTOzanimod vs
interferon β-1a: clinical and MRI results of RADIANCE part B - a
2-year phase 3 trial in relapsing multiple sclerosis; J.A.
CohenLocation: Parallel Session 16: Late Breaking News, Hall A
Poster Presentations:
Abstract #A-858-0032-00784; Thursday, October 26, 2017, 3:30
p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTCardiac safety of
ozanimod in a QT/QTc trial and a phase 2 trial in RMS; G.
ComiLocation: Poster Session 1, Poster Exhibition
Abstract #A-858-0015-00126; Thursday, October 26, 2017, 3:30
p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTEffect of ozanimod
(RPC1063) on action potential parameters in adult human Purkinje
fibres; N. Abi-GergesLocation: Poster Session 1, Poster
Exhibition
Abstract #A-858-0027-00623; Thursday, October 26, 2017, 3:30
p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTLower baseline
levels of vitamin D are associated with a higher risk of new lesion
development in patients with relapsing multiple sclerosis; G.J.
OpiteckLocation: Poster Session 1, Poster Exhibition
Abstract #A-858-0029-00488; Thursday, October 26, 2017, 3:30
p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTOzanimod does not
impact cytotoxic T lymphocyte function in vitro demonstrating
differentiation from fingolimod’s activity on SET-PP2A; D.
GuimondLocation: Poster Session 1, Poster Exhibition
Abstract #A-858-0032-00482; Thursday, October 26, 2017, 3:30
p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTOzanimod has an
improved nonclinical safety profile relative to fingolimod; S.
Meier-DavisLocation: Poster Session 1, Poster Exhibition
Abstract #A-858-0032-00480; Friday, October 27, 2017, 3:30 p.m.
– 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTComparison of
reproductive and juvenile nonclinical findings between ozanimod and
fingolimod; S. Meier-DavisLocation: Poster Session 2, Poster
Exhibition
Abstract #A-858-0015-00626; Friday, October 27, 2017, 3:30 p.m.
– 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTFingolimod activates
the 5-HT1A receptor in S1P3R/5-HT1A heterooligomer complexes in
vivo; K. DinesLocation: Poster Session 2, Poster Exhibition
Abstract #A-858-0000-02744; Friday, October 27, 2017, 3:30 p.m.
– 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTOzanimod demonstrates
preservation of brain volume at 1 and 2 years in two phase 3 trials
of relapsing multiple sclerosis (SUNBEAM and RADIANCE); D.L.
ArnoldLocation: Poster Session 2, Poster Exhibition
Abstract #A-858-0030-00783; Friday, October 27, 2017, 3:30 p.m.
– 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTOzanimod (RPC1063) is
potentially neuroprotective through direct activity on Th1 and Th17
T cell expansion and migration, monocyte migration and microglia
expansion; D. GuimondLocation: Poster Session 2, Poster
Exhibition
Abstract #A-858-0030-00485; Friday, October 27, 2017, 3:30 p.m.
– 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDTOzanimod (RPC1063) is
potentially neuroprotective through direct CNS effects; K.R. Taylor
MeadowsLocation: Poster Session 2, Poster Exhibition
E-posters
Abstract #A-858-0032-00490Lack of clinically meaningful changes
in cardiac effects from co-administration of ozanimod and a
beta-blocker or a calcium channel blocker; J.Q. Tran
Abstract #A-858-0027-00781Ozanimod (RPC1063) reduces the plasma
biomarker neurofilament light chain in preclinical rodent models of
multiple sclerosis; K.R. Taylor Meadows
About SUNBEAM™
SUNBEAM is a pivotal, phase III, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of two doses of oral ozanimod
(1.0 mg and 0.5 mg) against weekly intramuscular interferon beta-1a
(Avonex®) over a 12-month treatment period. The study included
1,346 people living with RMS across 152 sites in 20 countries.
The primary endpoint of the trial was ARR during the treatment
period. The secondary MRI endpoints were number of new or enlarging
hyperintense T2-weighted brain MRI lesions over 12 months, number
of gadolinium-enhanced brain MRI lesions at month 12 and percent
change from baseline in brain volume at month 12.
An analysis of the time to onset of disability progression was
pre-specified using pooled data from both the SUNBEAM and RADIANCE
Part B phase III trials.
About RADIANCE™
RADIANCE Part B is a pivotal, phase III, multicenter,
randomized, double-blind, double-dummy, active-controlled trial
evaluating the efficacy, safety and tolerability of two doses of
oral ozanimod (1.0 mg and 0.5 mg) against weekly intramuscular
interferon beta-1a (Avonex®) over a 24-month treatment period. The
study included 1,320 people living with RMS across 147 sites in 21
countries.
The primary endpoint of the trial was ARR over 24 months. The
secondary MRI endpoints were number of new or enlarging
hyperintense T2-weighted brain MRI lesions over 24 months, number
of gadolinium-enhanced brain MRI lesions at month 24 and percent
change from baseline in brain volume at month 24.
An analysis of the time to onset of disability progression was
pre-specified using pooled data from both the SUNBEAM and RADIANCE
Part B phase III trials.
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 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 is thought 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 (MS) 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 living with MS 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.
Relapsing multiple sclerosis (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 with no apparent
progression of disease. RMS is the most common disease course at
the time of diagnosis. Approximately 85 percent of patients are
initially diagnosed with RMS, compared with 10-15 percent with
progressive forms of the disease.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical 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. Follow
Celgene on Social Media: @Celgene, Pinterest, LinkedIn,
Facebook and YouTube.
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Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Catherine Cantone, 908-897-4256Senior Director,
Corporate Communications
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