Ozanimod showed effects on cognitive processing
speed in a post hoc analysis of 12-month data from SUNBEAM™ pivotal
trial
In separate post hoc analysis of pooled data
from phase 3 RADIANCE™ Part B and SUNBEAM trials, ozanimod reduced
annualized relapse rates and MRI lesions at 12 months in patients
with a disease state defined as early relapsing multiple sclerosis
compared with patients with more advanced disease
Celgene Corporation (NASDAQ:CELG) today announced the results of
two post hoc analyses of data from the phase 3 SUNBEAM™ and
RADIANCE™ Part B trials, which evaluated the efficacy and safety of
ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1)
and 5 (S1P5) receptor modulator, versus a first-line treatment,
Avonex® (interferon beta-1a) (IFN), in patients with relapsing
multiple sclerosis (RMS). These findings will be presented at
ECTRIMS 2018.
“Slowed cognitive processing, which is common in multiple
sclerosis, often impairs quality of life for people living with
this chronic condition,” 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 both
analyses. “The findings from these new analyses suggest that, when
compared to interferon, ozanimod has a beneficial effect on
processing speed.”
SUNBEAM evaluated two doses (0.92 mg and 0.46 mg, equivalent to
1 mg and 0.5 mg ozanimod HCI respectively) of oral ozanimod in
1,346 patients with RMS treated for at least one year. A post hoc
analysis of 12-month data from SUNBEAM to be presented today
examined the effect of ozanimod on cognitive processing speed,
based on performance on the Symbol Digit Modalities Test (SDMT).
Benefits in SDMT score at month 12 were seen with ozanimod versus
IFN (difference: 1.6; 95% confidence interval [CI]: 0.62, 2.56 for
ozanimod 1 mg and 1.2; 95% CI: 0.19-2.13 for ozanimod 0.5 mg). More
patients exhibited clinically meaningful (≥4-point) improvements in
processing speed at month 12 with ozanimod 1 mg (rate ratio, 1.3;
95% CI: 1.05, 1.55) and 0.5 mg (1.2; 95% CI: 0.94, 1.40) versus
IFN.
A second post hoc analysis on annualized relapse rates (ARR) and
MRI lesions examined the effect of ozanimod in patients with early
RMS compared with patients with more advanced disease. Early RMS
was defined based on a composite baseline profile, including 3
years or less since diagnosis, an Expanded Disability Status Scale
(EDSS) of 3.5 or less, and the use of one or no disease-modifying
treatments. In the pooled phase 3 studies, two doses of oral
ozanimod (1 mg and 0.5 mg) were evaluated compared with IFN in
2,659 patients treated for two years.
For patients with early RMS (n=1,392) in this analysis, ARR was
lower at 12 months with ozanimod 1 mg (ARR=0.149) and ozanimod 0.5
mg (ARR=0.200) compared with IFN (ARR=0.285). ARR was also lower
with ozanimod versus IFN in patients with more advanced RMS
(n=1,267) (ozanimod 1 mg: 0.217; 0.5 mg: 0.277; IFN: 0.363).
Ozanimod also showed a reduction of MRI lesions in both early
and more advanced RMS in this analysis. For patients with early
RMS, the mean number of gadolinium-enhancing (GdE) lesions at 12
months was 0.263 with ozanimod 1 mg, 0.458 with ozanimod 0.5 mg and
0.656 with IFN. For those with more advanced RMS, the mean number
of GdE lesions was 0.278, 0.323 and 0.915, respectively. Similarly,
the mean number of new or enlarging T2 lesions at 12 months for
patients with early RMS was 2.952 for ozanimod 1 mg, 3.744 for
ozanimod 0.5 mg and 4.633 for IFN. For patients with more advanced
RMS, the numbers were 2.514, 2.903 and 4.710, respectively.
“These analyses provide additional encouraging data for ozanimod
in relapsing multiple sclerosis, from its potential to influence
cognitive processing to showing results in patients with either
early or more advanced forms of the disease,” said Jay Backstrom,
M.D., Chief Medical Officer for Celgene. “Ozanimod has the
potential to offer the multiple sclerosis community a new oral
option for the treatment of relapsing multiple sclerosis, and we
continue to work with regulatory bodies in the U.S. and EU in our
efforts to bring this treatment to patients.”
In the SUNBEAM and RADIANCE clinical trials, the most common
adverse reactions (≥ 5 percent) that were higher with ozanimod than
with IFN were upper respiratory tract infections, urinary tract
infections, increases of alanine aminotransferase and increases of
gamma-glutamyl transferase.
Ozanimod is an investigational compound that is not approved for
any use in any country.
About SUNBEAM™
SUNBEAM 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 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 included the 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 3-month confirmed disability
progression was pre-specified using pooled data from both the
SUNBEAM and RADIANCE Part B phase 3 trials.
About RADIANCE™
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
1,320 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 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 brain volume at month 24.
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 a novel, oral, selective, sphingosine 1-phosphate 1
(S1P1) and 5 (S1P5) receptor modulator in development for
immune-inflammatory indications including relapsing multiple
sclerosis, ulcerative colitis and Crohn's disease.
Selective binding with S1P1 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 S1P5 is thought to activate specific
cells within the central nervous system. This has the potential to
enhance remyelination (when the body is able to repair damaged
myelin after inflammation is reduced) and prevent synaptic defects.
Ultimately, neurological damage may be prevented.
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.
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. We undertake 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 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.
Hyperlinks are provided as a convenience and for informational
purposes only. Celgene bears no responsibility for the security or
content of external websites.
All trademarks are the property of their respective owners.
###
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181010005093/en/
For inquiries, please contact:Celgene CorporationInvestors:Nina
GoworekExecutive Director, Investor
Relations908-673-9711orMedia:Catherine CantoneSenior Director,
Corporate Communications908-897-4256
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Apr 2023 to Apr 2024