Study met the primary endpoint of annualized
relapse rate (ARR) and key secondary MRI endpoints of T2 and GdE
lesions, compared to interferon (IFN) β-1a (Avonex®); a very low
rate of disability progression observed across the three treatment
groups in the pooled analysis; disability endpoint not met
Safety and tolerability consistent with prior
phase II and III studies
New Drug Application submission to the U.S.
Food and Drug Administration planned by end of 2017
Celgene Corporation (NASDAQ:CELG) today announced that its phase
III RADIANCE 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®).
RADIANCE evaluated two doses (0.5 mg and 1 mg) of oral ozanimod,
with patients treated for two years. The trial enrolled 1,313 RMS
patients in 21 countries. Both ozanimod 0.5 mg and 1 mg doses
demonstrated statistically significant and clinically meaningful
reductions in the primary endpoint of ARR and the key secondary
endpoints of the number of new or enlarging T2 MRI lesions over 24
months of treatment compared to Avonex and the number of
gadolinium-enhancing MRI lesions at 24 months of treatment compared
to Avonex®.
In a pre-specified pooled analysis of the time to confirmed
disability progression in both the RADIANCE and SUNBEAM phase III
trials, a very low rate of disability progression was observed
across the three treatment groups, and ozanimod did not reach
statistical significance compared to Avonex®. Additionally, both
doses of ozanimod demonstrated statistically significant reductions
in brain atrophy compared to Avonex® in each phase III trial.
The overall safety and tolerability profile was consistent with
results from the recently completed phase III SUNBEAM RMS trial and
previously reported phase II trials.
“The results of the phase III RADIANCE trial confirm the data
observed in SUNBEAM and are consistent with the long-term phase II
RADIANCE trial,” said Bruce Cree, MD, Ph.D., Associate Professor of
Neurology, Multiple Sclerosis Center, University of California, San
Francisco. “The significant effects seen with ozanimod on relapse
and MRI outcomes, including brain volume loss, coupled with the
safety and tolerability profile observed in the two phase III
trials, represent an exciting advancement for a disease which needs
additional oral therapies with favorable benefit-risk
profiles.”
“We are excited by the results seen to-date across both pivotal
trials, which further validated ozanimod’s promising benefit-risk
profile relative to current therapies,” said Terrie Curran,
President of Celgene Inflammation and Immunology. “We plan to begin
submitting global registration dossiers by the end of the year to
bring this oral therapy to patients with relapsing multiple
sclerosis.”
Further analyses of the RADIANCE trial are ongoing. In February
2017, Celgene announced positive top-line results from the second
active comparator phase III, SUNBEAM, in RMS. Detailed results from
the RADIANCE and SUNBEAM trials will be presented at an upcoming
medical congress. A New Drug Application submission to the U.S.
Food and Drug Administration, based on the combined SUNBEAM and
RADIANCE trials for RMS, is expected by the end of 2017.
About RADIANCE
RADIANCE 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
(0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a
(Avonex®) over a 24 month treatment period. The study included
1,313 RMS patients across 147 sites in 21 countries.
The primary endpoint of the trial is ARR over 24 months. The key
secondary endpoints are: the number of new or enlarging
hyperintense T2-weighted brain MRI lesions over 24 months and the
number of GdE brain MRI lesions 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
phase III trials.
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
(0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a
(Avonex®) over a 24 month treatment period. The study included
1,346 RMS patients across 152 sites in 20 countries.
The primary endpoint of the trial was ARR during the treatment
period. The key secondary endpoints were: 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.
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. 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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version on businesswire.com: http://www.businesswire.com/news/home/20170522005603/en/
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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