Celgene to Present New Data on Investigational Compounds at UEGW and ACG Congresses
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
Abstract #OP108; Monday, October 17, 2016, 4:57 PM CET / 10:57 AM EDT
Safety and Efficacy of Long-Term Treatment with Ozanimod, and Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: TOUCHSTONE Extension; Brian Feagan
Location: Room C
Abstract #LB16; Tuesday, October 18, 2016, 12:27 PM CET / 6:27 AM EDT
A 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 Feagan
Location: Room M
Abstract #OP325; Wednesday, October 19, 2016, 9:06 AM CET / 3:06 AM EDT
A 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 Hirano
Location: Room M
Abstract #P1423; Wednesday, October 19, 2016, 9:00 AM – 2:00 PM CET / 3:00 – 8:00 AM EDT
Effects of High- and Low-fat Meals on the Pharmacokinetics of Ozanimod, a Novel Sphingosine 1-Phosphate Receptor Modulator; Jonathan Tran
Location: 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
Abstract #19; Tuesday, October 18, 5:30 PM CET / 11:30 AM EDT
A 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 Dellon
Location: Exhibit Hall C
Abstract #30; Tuesday, October 18, 2016, 5:50 PM CET / 11:50 AM EDT
Safety and Efficacy of Long-Term Treatment with Ozanimod, and Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: TOUCHSTONE Extension; William Sandborn
Location: Exhibit Hall C
Abstract #P1146; Monday, October 17, 2016, 7:30 PM – 1:00 AM CET / 1:30 – 7:00 PM EDT
Effects of High- and Low-fat Meals on the Pharmacokinetics of Ozanimod, a Novel Sphingosine 1-Phosphate Receptor Modulator; Paul Frohna
Location: Exhibit Hall C
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.
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.
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.
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 .
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.
For inquiries, please contact:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
Catherine Cantone, 732-564-3592
Senior Director, Corporate Communications
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Sprint Selects Synchronoss to Lead its Digital Transformation25.2.2018 23:19 | Pressemelding
Synchronoss Technologies, Inc. (NASDAQ:SNCR), a global leader and innovator of cloud, messaging, and digital products, today announced it has been selected by Sprint to lead the transformation of its online environment for business customers. Synchronoss’ Digital platform will help Sprint simplify its online order management process, generate more revenue, and reduce its costs. Stage one of the new deployment will be focused on Sprint’s wireless business customers, but will extend to include wireline, IoT, and Sprint value added solution business operations in the future. Sprint, through its Sprint Now program, remains on the digital transformation offensive, enhancing its online channels to constantly improve its customer experience. Sprint’s relationship with Synchronoss is central to this initiative as it looks to simplify its online order management process, through the creation of a converged customer experience portal. Once accessed, this portal will enable all Sprint business us
Huawei Brings the All-Connected World to Mobile World Congress25.2.2018 13:30 | Pressemelding
Building on its success in delivering beautifully-designed and powerful high-end mobile devices, Huawei Consumer Business Group (CBG) today unveiled the HUAWEI MateBook X Pro, the HUAWEI MediaPad M5 Series and the HUAWEI 5G customer-premises equipment (CPE), the world’s first commercial terminal device supporting the globally recognized 3GPP telecommunications standard for 5G. With stunning new design updates and outstanding performance advances, Huawei’s new devices showcase the power of technology to deliver innovative computing experiences ready for the mobile world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180225005135/en/ MateBook X Pro (Photo: Business Wire) “At Huawei, we’re guided by a vision of an all-connected world, and to achieve that goal, we invest significantly in research and development to understand the ways in which people interact and connect with technology,” said Richard Yu, CEO of Huawei CBG. “We’
The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings24.2.2018 10:00 | Pressemelding
The 6th Annual World Patient Safety, Science & Technology Summit kicked off with an important announcement about the progress being made to save lives in hospital settings. Nearly 4,600 hospitals in 44 countries have committed to adopting patient safety processes that are proven to eliminate preventable deaths in hospitals. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180224005027/en/ England’s Health and Social Care Secretary, Rt. Hon. Jeremy Hunt, launches groundbreaking new measures on Day One of the 6th Annual World Patient Safety, Science & Technology held in London (Photo: Business Wire) The Patient Safety Movement Foundation has taken on an inspiring and ambitious goal of reducing preventable patient deaths in hospitals to ZERO by 2020. The annual Summit in central London plays a major role in taking on that challenge with the participation of 300 global leaders, medical experts, medical technology CEOs, and patient
WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software24.2.2018 09:06 | Pressemelding
Communications Consultants Worldwide Ltd. (CCww), global innovator of 3GPP® technologies, has licensed its NB-IoT protocol-stack software to WuQi Technologies Inc., a leading global developer of highly integrated mixed-signal SoC solutions, and the latest licensee of CCww’s NB-IoT Release 13 UE protocol-stack software. Communications Consultants Worldwide (CCww) is working with WuQi Technologies for the integration of its NB-IoT protocol-stack software onto WuQi Technologies’ highly innovative SoC. This relationship, catalyzed by T2M, is enabling the production of a highly integrated, very low power, NB-IoT SoC chipset targeting IoT Smart City, Smart Home, and wearable applications. CCww’s CEO, Richard Carter, said, “NB-IoT is CCww’s latest cellular Protocol-stack SW. We are excited to be working with WuQi to enable a sector-leading NB-IoT SoC, pushing back boundaries of performance and battery life for the next generation of IoT. See our demonstration at the Mobile World Congress (Hal
IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution23.2.2018 15:57 | Pressemelding
IDEMIA, the global leader in Augmented Identity for an increasingly digital world, announces today that it has implemented facial recognition technology on EasyOpen, a solution previously developed with its partner Omoove, a wholly-owned Octo Telematics company, Europe’s leading Shared Mobility technology provider. The digital enrolment process combined with facial recognition technology will securely enroll and authenticate the driver before EasyOpen automatically opens the car. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180223005506/en/ (Photo: Idemia) You will never rent a car the same way thanks to EasyOpen solution that combines IDEMIA’s expertise in secure service enablement and Omoove’s experience in Shared Mobility platforms and on-board technology. The first version of the solution was launched last year and allows drivers, who have already registered on the application, to use their smartphones as a key to open
SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes23.2.2018 14:00 | Pressemelding
SM-Optics launches FLEXSET, a single chip embedding multiple processing functionalities raising the bar for performances, density and architectural flexibility. The FLEXSET is the heart of the Lightmode product family. FLEXSET OTN switching matrix scales from 300Gbps to 1Tbps and can be addressed by ports spanning from traditional low-speed services like 2Mbps over micro-OTN, to layer2 and layer3 over ODUFlex, 100G over ODU4 and 200G over FlexO. Thanks to its embedded capabilities including multi-technology OAM, packet processing, synchronization and fast protection functions, FLEXSET operates by design at the lowest latency performances and features an Intel Stratix 10 FPGA. Following the launch of micro-OTN, a revolutionary approach to efficiently extend OTN protocol to low speed services, the launch of FLEXSET advances the vision of a highly interconnected metro network and of micro nodes. Revolving around functional block elements, micro nodes collapse in few rack units OTN and pho