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
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
IFF Launches Re-Imagine…™ Programs to Tap Unmet Consumer Opportunities, Speed Innovation18.10.2017 20:15 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, launched their Re-Imagine programs to accelerate innovation and increase agility to capture unmet opportunities in the changing food and beverage market. Based on a combination of future trends analysis, consumer insights, and a modernized cross-category development process, the programs guide the Company’s research and development efforts to ensure an innovation pipeline that addresses evolving consumer needs and desires. “The Re-Imagine programs area tangible expression of our commitment to advance taste for our customers – and consumers,” said IFF Chairman and CEO Andreas Fibig. “It is another way in which we show how we are dedicated to being our customers’ partner of choice as we progress on our business strategy, imbu
Sparkol Launches VideoScribe 318.10.2017 13:24 | Pressemelding
Introducing VideoScribe Version 3 by Sparkol. Already used by over two million people across the world to create engaging explainer videos, Version 3 of the highly intuitive software comes packed full of new features, including: An improved user experience and slick UI - animate easier than ever before Enhanced search - find exactly the image you need in record time Intelligent image recommendations - focus your creativity on your video instead Smoother performance - maximum productivity when using the software VideoScribe customers include the world’s largest brands (HP, BBC, Sky and the University of British Columbia), businesses across every sector, leading education providers, award-winning teachers, charities, campaigners, and coun
Piraeus Bank: Agreement for the Sale of Serbian Operations18.10.2017 13:06 | Pressemelding
Piraeus Bank announces that it has entered into an agreement to sell its Serbian banking and leasing operations to Direktna Banka A.D., a local Serbian banking group that has been strongly growing its presence in the market, for a total cash consideration between €58mn up to €61mn, depending on the financial performance of the divested assets until completion of the transaction, through a combination of direct sale price and simultaneous reduction of capital in Piraeus Bank Beograd AD. The transaction is conditional upon the usual corporate and regulatory approvals, including those of the National Bank of Serbia and the Hellenic Financial Stability Fund. The transaction represents another step towards the implementation of Piraeus Bank’s Restructuring Plan commitments, as those were agreed with the Directorate General of Competition of the European Commission. The transactio
Introducing InVision Studio, The World’s Most Powerful Screen Design Tool18.10.2017 13:01 | Pressemelding
InVision, the product design platform powering the world’s best digital experiences, today introduced Studio, a powerful new tool that will change the way screen design is done. InVision Studio was created by working closely with the world’s best design teams and finding inspiration in how they create beloved digital products. The launch of Studio comes at a time when modern organizations are shaping and redefining entire markets through their focus on digital customer experience. InVision already powers the product design process of more than 3 million people at tens of thousands of companies, including eighty percent of the Fortune 100 and brands like Airbnb, Uber, HBO, Amazon, IBM, Nike, and Slack. This new product reflects a major evolution of the digital product design workflow. With Studio, InVision has developed an end-to-end platform for designing digit
SmartStream and Credit Suisse Expand their Agreement from the Processing of Invoices and Reconciliations to Now Include Listed Derivatives Brokerage Fees18.10.2017 12:00 | Pressemelding
SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announced that its original agreement with Credit Suisse was recently expanded to include the processing of Listed Derivatives Brokerage fees which began in February of this year. This expansion in SmartStream’s partnership with Credit Suisse complements its existing managed service solution for the processing of invoices and reconciliations within Credit Suisse’s OTC Fixed Income Derivatives, US Listed Equity Options and Cash Equities businesses across brokerage, clearing and exchange fees operations, which began in June of 2016. The managed service enables the bank to advance the operational efficiencies created through the use of the utility-based solutions offered by SmartStream, utilizing their proprietary execution fees and expense management software. By centralizing the ent
Biogen Confirms Commitment to Tackle Multiple Sclerosis Through Comprehensive Approach18.10.2017 11:30 | Pressemelding
Biogen (NASDAQ: BIIB) confirms its comprehensive approach to tackle multiple sclerosis (MS) at the seventh Joint Meeting of the European Committee for Treatment and Research in MS and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS; 25 – 28 October). “With more than 25 years of scientific leadership in MS, Biogen’s commitment is unwavering,” said Michael Ehlers, executive vice president, Research & Development at Biogen. “Our expertise puts Biogen in a unique position with a comprehensive approach including active research and clinical development on how to repair the damage to the central nervous system from relapsing forms of MS, a portfolio of new drug candidates that we are advancing to the clinic, our collaboration to identify a digital biomarker, our focus to advance understanding of the disease through global data collection with MS PATHS, active pursuit
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom