Exploratory phase 1b study interim data
assessing the effects of oral GED-0301 (mongersen) on both
endoscopic and clinical outcomes at 12 weeks in patients with
active Crohn’s disease
TOUCHSTONE extension data assessing safety and
efficacy of long term treatment with ozanimod, an oral S1P1 and 5
receptor modulator, in patients with moderate to severe ulcerative
colitis
Data from the phase 2 HEROES study evaluating
the efficacy and safety of RPC4046 in patients with active
eosinophilic esophagitis
Celgene Corporation (NASDAQ:CELG) today announced that findings
from clinical trials of investigational compounds GED-0301
(mongersen), ozanimod and RPC4046 will be presented at the United
European Gastroenterology (UEG) Week, October 15-19, in Vienna,
Austria. Ozanimod and RPC4046 data will also be included at the
American College of Gastroenterology (ACG) Annual Scientific
Meeting, October 14-19, in Las Vegas.
Among the data that will be presented is an ongoing, exploratory
phase 1b study of GED-0301, an oral compound being investigated for
active Crohn’s disease. The ongoing study is evaluating the effects
of three different regimens of oral GED-0301 on both endoscopic and
clinical outcomes in patients with active Crohn's disease in a
12-week treatment phase, followed by an observation (off treatment)
phase of up to 52 weeks. The study was designed to further enhance
the understanding of GED-0301 activity in a difficult-to-treat,
moderate-to-severe patient population. The data were accepted as a
late breaking oral presentation at UEG Week.
An analysis of the open-label extension of the TOUCHSTONE trial
will evaluate the efficacy and safety of daily 1 mg oral ozanimod,
an investigational selective S1p 1 and 5 receptor modulator,
through week 44 of the open label extension in patients with
moderate to severe ulcerative colitis. The 32 week double-blind
placebo-controlled phase of TOUCHSTONE evaluated the efficacy and
safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo
in patients with moderate to severe active ulcerative colitis.
Results from this induction and maintenance phase of the trial have
been previously reported. The open-label extension phase included
TOUCHSTONE participants from all three treatment arms who either
did not respond to treatment after the induction phase, relapsed
during the maintenance phase or completed the maintenance phase.
These results will be featured in an oral presentation at both ACG
and UEG Week.
Results from the phase 2 HEROES dose-ranging study will evaluate
the efficacy and safety of RPC4046 in patients with active
eosinophilic esophagitis (EoE), a rare but potentially serious
allergic/immune disorder for which there are currently no approved
treatments. RPC4046 is an investigational humanized monoclonal
antibody that binds with high selectivity to both subunits (alpha 1
& 2) of the IL-13 receptor. The data will be featured in an
oral presentation at both ACG and UEG Week.
“GED-0301, ozanimod and RPC4046 have the potential to be
transformational therapies for people with inflammatory bowel
diseases and other serious gastrointestinal diseases, and we are
excited about these new data,” said Scott Smith, President, Celgene
Inflammation & Immunology. “Celgene’s strong presence at the
UEGW and ACG congresses underscores our commitment to providing
new, innovative therapies to patients worldwide.”
The following abstracts will be presented at United European
Gastroenterology (UEG) Week (all times, CET and EDT):
Abstracts at a Glance
Oral Presentations:Abstract #OP108; Monday, October 17,
2016, 4:57 PM CET / 10:57 AM EDTSafety and Efficacy of Long-Term
Treatment with Ozanimod, and Oral S1P Receptor Modulator, in
Moderate to Severe Ulcerative Colitis: TOUCHSTONE Extension; Brian
FeaganLocation: Room C
Abstract #LB16; Tuesday, October 18, 2016, 12:27 PM CET / 6:27
AM EDTA Randomized, Double-Blind, Multicenter Study to Explore the
Efficacy of Oral GED-0301 (Mongersen) on Endoscopic Activity and
Clinical Effects in Both TNF-Naive and TNF-Experienced Subjects
with Active Crohn’s Disease; Brian FeaganLocation: Room M
Abstract #OP325; Wednesday, October 19, 2016, 9:06 AM CET / 3:06
AM EDTA Randomised, Double-Blind, Placebo-Controlled Trial of a
Novel Recombinant, Humanised, Anti-Interleukin-13 Monoclonal
Antibody (RPC4046) in Patients with Active Eosinophilic
Oesophagitis: Results of the HEROES Study; Ikuo HiranoLocation:
Room M
Poster Presentation:Abstract #P1423; Wednesday, October
19, 2016, 9:00 AM – 2:00 PM CET / 3:00 – 8:00 AM EDTEffects of
High- and Low-fat Meals on the Pharmacokinetics of Ozanimod, a
Novel Sphingosine 1-Phosphate Receptor Modulator; Jonathan
TranLocation: Poster Exhibition - Hall X4 and X5
The following abstracts will be presented at American College of
Gastroenterology (all times, CET and EDT):
Abstracts at a Glance
Oral Presentations:Abstract #19; Tuesday, October 18,
5:30 PM CET / 11:30 AM EDTA Randomised, Double-Blind,
Placebo-Controlled Trial of a Novel Recombinant, Humanised,
Anti-Interleukin-13 Monoclonal Antibody (RPC4046) in Patients with
Active Eosinophilic Oesophagitis: Results of the HEROES Study; Evan
DellonLocation: Exhibit Hall C
Abstract #30; Tuesday, October 18, 2016, 5:50 PM CET / 11:50 AM
EDTSafety and Efficacy of Long-Term Treatment with Ozanimod, and
Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative
Colitis: TOUCHSTONE Extension; William SandbornLocation: Exhibit
Hall C
Poster Presentation:Abstract #P1146; Monday, October 17,
2016, 7:30 PM – 1:00 AM CET / 1:30 – 7:00 PM EDTEffects of High-
and Low-fat Meals on the Pharmacokinetics of Ozanimod, a Novel
Sphingosine 1-Phosphate Receptor Modulator; Paul FrohnaLocation:
Exhibit Hall C
About GED-0301
The investigational oral antisense therapy GED-0301 is an
oligonucleotide designed to target the messenger RNA (mRNA) for
Smad7, thereby reducing Smad7 protein levels. In patients with
Crohn’s disease, abnormally high levels of Smad7 interfere with
TGF-β1 anti-inflammatory pathways in the gut, leading to increased
inflammation. GED-0301 is designed to act locally to reduce Smad7
levels with negligible systemic exposure.
GED-0301 is an investigational compound that is not approved for
any use in any country.
About Ozanimod
Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1
and 5 receptor modulator in development for immune-inflammatory
indications including inflammatory bowel disease and relapsing
multiple sclerosis. Treatment with S1P receptor modulators is
believed to work by interfering with S1P signaling and preventing a
certain subtype (ccr7+) of lymphocytes (a type of white blood cell)
from exiting the lymph nodes and contributing to tissue
inflammation.
Ozanimod is an investigational compound that is not approved for
any use in any country.
About RPC4046
RPC4046 is a humanized monoclonal antibody directed against
interleukin-13 (IL-13), a target that has been validated in other
related allergic indications. IL-13, produced by the immune system,
is known to cause changes in the esophagus that lead to
inflammation. RPC4046 binds an IL-13 epitope that prevents its
binding to both the alpha 1 and alpha 2 subunits of the IL-13
receptor.
RPC4046 is an investigational compound that is not approved for
any use in any country.
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 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 our other
reports filed with the U.S. Securities and Exchange Commission.
###
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For inquiries, please contact:Celgene
CorporationInvestors:Patrick E. Flanigan III, 908-673-9969Corporate
Vice President, Investor RelationsorMedia:Catherine Cantone,
732-564-3592Senior Director, Corporate Communications
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