Patients across all age subgroups treated with
ozanimod lost less cortical grey matter volume than did those
treated with interferon beta-1a over 24 months
Data from new analysis of pivotal ozanimod
trial will be presented at 2019 AAN Annual Meeting
Celgene Corporation (NASDAQ:CELG) today announced the results of
a post-hoc analysis of data from the Phase 3 RADIANCE™ Part B trial
showing that ozanimod reduced cortical grey matter volume loss
versus first-line treatment, Avonex® (interferon beta-1a), in
adults with relapsing multiple sclerosis (RMS) across all age
groups, including patients ages 18 to 25. The analysis will be
presented at the 2019 American Academy of Neurology (AAN) Annual
Meeting in Philadelphia, May 4-10, 2019.
“Brain volume loss is associated with long-term physical
disability and cognitive issues in multiple sclerosis,” said Bruce
Cree, M.D., Ph.D., M.A.S., Professor of Neurology at the University
of California San Francisco (UCSF) Weill Institute for
Neurosciences, Clinical Research Director at the UCSF MS Center,
and an author of the analysis. “Ozanimod reduced the loss of
cortical grey matter volume across all age groups in this
study.”
RADIANCE evaluated two doses of oral ozanimod (0.92 mg and 0.46
mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively)
compared with interferon beta-1a in 1,313 patients with RMS between
the ages of 18 and 55 years old. In this post-hoc analysis of 874
patients, treatment effect on serial brain volume, including
thalamic volume and cortical grey matter, was evaluated by patient
age (18 to 25, n=146; 26 to 34, n=265; 35 and older, n=463) at
baseline, 12 months and 24 months.
Patients in the 18 to 25 age group tended to have greater brain
volume at baseline but more active disease as measured by
gadolinium-enhancing MRI lesions. There was also a trend for this
age group to experience greater whole brain volume loss at both 12
and 24 months compared with the older groups.
Patients across all age groups treated with ozanimod lost less
cortical grey matter volume than did those treated with interferon
beta-1a over 24 months, including patients in the 18 to 25 age
group.
In the RADIANCE Part B trial, the most common adverse reactions
(≥ 5 percent) that were higher with ozanimod than with interferon
beta-1a were upper respiratory tract infections, urinary tract
infections, increases of alanine aminotransferase and increases of
gamma-glutamyl transferase.
“Since loss of brain volume can be associated with disease
progression, there is a need for early diagnosis and treatment in
multiple sclerosis,” said Alise Reicin, M.D., President, Global
Clinical Development for Celgene. “This analysis adds to growing
evidence supporting the potential use of ozanimod to treat adults
with relapsing multiple sclerosis, including the youngest patients
studied, who also showed the most rapid loss in brain volume in
this study.”
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor
modulator that binds with high affinity selectively to S1P subtypes
1 (S1P1) and 5 (S1P5). Ozanimod is an investigational compound that
is not approved for any use in any country.
Celgene submitted a New Drug Application to the U.S. Food and
Drug Administration and a Marketing Authorization Application to
the European Medicines Agency in March 2019 for ozanimod for the
treatment of adults with RMS.
About RADIANCE™ Part B
RADIANCE Part B is a pivotal, Phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of two doses of oral ozanimod
(0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI
respectively) against weekly intramuscular interferon beta-1a
(Avonex®) over a 24-month treatment period. The study included
1,313 people living with RMS across 150 sites in 21 countries.
The primary endpoint of the trial was annualized relapse rates
(ARR) over 24 months. The secondary MRI endpoints included the
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 whole brain
volume at month 24. Cortical grey and thalamic volume changes were
also prospectively assessed versus active comparator.
An analysis of the time to onset of 3-month confirmed disability
progression was pre-specified using pooled data from both the
SUNBEAM and RADIANCE Part B Phase 3 trials.
About Ozanimod
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor
modulator that binds with high affinity selectively to S1P subtypes
1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in
lymphoid tissues. The mechanism by which ozanimod exerts
therapeutic effects in multiple sclerosis is unknown, but may
involve the reduction of lymphocyte migration into the central
nervous system.
Ozanimod is in development for immune-inflammatory indications
including RMS, ulcerative colitis and Crohn's disease.
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. MS 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 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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are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,\"
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otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our 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 our Annual
Report on Form 10-K and our other reports filed with the U.S.
Securities and Exchange Commission, including factors related to
the proposed transaction between Bristol-Myers Squibb and Celgene,
such as, but not limited to, the risks that: management’s time and
attention is diverted on transaction related issues; disruption
from the transaction make it more difficult to maintain business,
contractual and operational relationships; legal proceedings are
instituted against Bristol-Myers Squibb, Celgene or the combined
company could delay or prevent the proposed transaction; and
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