Ozanimod demonstrated continued efficacy over
96 weeks on MRI and clinical measures of multiple sclerosis disease
activity
No new safety or tolerability issues were
identified during the ongoing blinded extension
Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ:CELG), today announced results from the 96-week
blinded extension period (for a total of up to 120 weeks of
exposure on treatment) of the RADIANCE phase 2 trial of ozanimod,
an investigational oral, selective S1P 1 and 5 receptor modulator,
in patients with relapsing multiple sclerosis (RMS). The results
were presented at the 32nd Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS), which is
being held in London from September 14-17, 2016.
“The data from this blinded extension are encouraging and
further support evaluation of the benefit-risk profile of ozanimod
in the ongoing phase 3 trials of patients with relapsing multiple
sclerosis,” said Giancarlo Comi, MD, Professor of Neurology,
Chairman of the Department of Neurology, and Director of the
Institute of Experimental Neurology, at Vita-Salute San Raffaele
University, Scientific Institute San Raffaele, Milan.
As previously announced at ECTRIMS 2014, RADIANCE met its
primary efficacy endpoint — reduction in the cumulative number of
total gadolinium-enhancing (GdE) lesions, as determined by MRI,
from week 12 to week 24. In the blinded extension period of the
study, patients originally randomized to ozanimod continued their
assigned dose (0.5 mg, n = 85; 1 mg, n = 81), while patients in the
placebo arm were randomized to either dose of ozanimod (0.5 mg, n =
41; 1 mg, n = 42). The extension week 96 visit was completed by 224
of the patients (90 percent) who entered the extension study.
At extension week 96, the mean number of GdE lesions was 0.3 for
patients on the 0.5 mg dose and 0.1 for the 1 mg dose, compared
with 0.4 and 0.1, respectively, at week 48. The proportion of
patients who were free of GdE lesions was 91 percent for the 0.5 mg
dose and 89 percent for the 1 mg dose. The cumulative number of new
or enlarging T2-hyperintense lesions was 1.8 for the 0.5 mg dose
and 0.6 for the 1 mg dose, compared with 1.3 and 0.7, respectively,
at week 48.
The effect on unadjusted annualized relapse rate (uARR) was
maintained in both ozanimod dose groups with uARR of 0.30 for the
0.5 mg dose and 0.19 for the 1 mg dose at extension week 96, and
0.26 and 0.15, respectively, at week 48.
No evidence of disease activity (NEDA: no GdE or new/enlarging
T2 lesions, and no relapse or increase in Expanded Disability
Status Scale [EDSS]) was achieved in 44 percent and 39 percent of
patients at extension week 48 and 96, respectively, on the 0.5 mg
dose and 62 percent and 47 percent on the 1 mg dose.
Reported treatment-emergent adverse events (AEs) were comparable
across ozanimod dose groups; the most common reported AEs during
the blinded extension (weeks 24 to 96) were minor infections
(nasopharyngitis, respiratory tract and urinary tract) and
headache. Alanine aminotransferase at least three times the upper
limit of normal was reported in 11 patients (4.4 percent) through
extension week 96. Consistent with extension week 48 data, no
noteworthy occurrences of cardiac, pulmonary, serious opportunistic
infections, ophthalmologic, or malignancy-related TEAEs were
observed. No first-dose TEAEs of bradycardia of AV block ≥ 2nd
degree were reported from day 1 of the study or day 1 of the
extension.
“These 2-year safety and efficacy results further underscore the
potential of ozanimod to offer a new oral therapeutic option for
patients with this chronic condition. Based on these findings, and
as part of our commitment to bringing innovative medicines to this
patient community, we look forward to the continued study of this
compound in the two ongoing pivotal phase 3 clinical trials in
RMS,” said Scott Smith, President, Celgene Inflammation &
Immunology.
About RADIANCE
The phase 2 portion of RADIANCE is a randomized, double-blind,
placebo controlled study assessing the efficacy, safety and
tolerability of two orally administered doses (0.5 mg and 1 mg) of
ozanimod against placebo in 258 patients with relapsing multiple
sclerosis across 55 sites in 13 countries, which was followed by a
2-year blinded extension period where all patients received
ozanimod. The primary endpoint of the placebo–controlled trial is
the reduction in the cumulative number of total GdE lesions
determined by MRI from week 12 to week 24 of study treatment, a
standard endpoint for phase 2 trials in relapsing multiple
sclerosis. The secondary endpoints of the trial were: the number of
GdE at week 24, the cumulative number of new or enlarging
T2-hyperintense lesions at weeks 12–24, the annualized relapse rate
from baseline until week 24 and safety and tolerability, as judged
by the site investigator.
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 and inflammatory bowel disease. Treatment with S1P
receptor modulators is believed to work by interfering with S1P
signaling and blocking the response of lymphocytes (a type of white
blood cell) to exit signals from the lymph nodes, sequestering them
within the nodes. The result is a reduction of circulating T and B
lymphocytes that leads to anti-inflammatory activity by inhibiting
migration of specific lymphocytes to sites of inflammation.
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 400,000 people in the U.S. and approximately 2.5
million people worldwide.
Relapsing multiple sclerosis 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. Relapsing multiple sclerosis 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 International Sàrl, located in Boudry, Switzerland, is a
wholly-owned subsidiary and international headquarters of Celgene
Corporation. 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 gene and protein regulation. 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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