New Analyses from Pivotal Phase 3 Trials of Oral Ozanimod to Be Presented at ECTRIMS 2018
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.
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.
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.
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.
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.
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.
For inquiries, please contact:
Executive Director, Investor Relations
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
Hilton Launches New Brand, Signia Hilton, Delivering Sophisticated Travel While Reimagining Meetings and Events22.2.2019 17:00:00 | Pressemelding
Hilton (NYSE: HLT) today announced the launch of Signia Hilton, its dynamic, new meetings-and-events-focused brand. The portfolio of hotels is setting out to transform the industry for meeting professionals and sophisticated business travelers by infusing state-of-the-art technology and design into every aspect of the guest experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005071/en/ The brand further reinforces Hilton’s commitment to innovation that meets the evolving needs of today’s travelers and will bring premium experiences to top urban and resort destinations around the world. “In our 100th year of hospitality, we are more focused than ever on providing exceptional experiences to all of our guests – and that includes evolving those experiences to meet their changing needs,” said Christopher J. Nassetta, president and CEO, Hilton. “We are proud to launch Signia Hilton, which exemplifies our innovative sp
Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans22.2.2019 16:30:00 | Pressemelding
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1. Raymond W. Cohen, Chief Executive Officer of Axonics, said, “Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our te
Fantastec Joins Forces with Arsenal FC Launching Official Blockchain Collectibles App22.2.2019 14:30:00 | Pressemelding
Fantastec announced today its first football licensing agreement with Premier League club Arsenal FC for a new blockchain authenticated collectibles app called Fantastec SWAP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005277/en/ Arsenal players appear on Fantastec SWAP in official licensing deal (Graphic: Business Wire) London-based Fantastec is a leading sports fan technology innovator, and its blockchain based ‘SWAP’ app will have broad appeal to global sports fans, gamers and sports card collectors alike. Fantastec SWAP unlocks unique and authentic club content through the app, like player autographs and exclusive footage. With its innovative blockchain technology, fans around the world can now discover, collect and swap officially licensed club collectibles with other fans with complete trust. “Fantastec SWAP is a game-changer for international football fans as well the sports collectibles industry,” commented
Volkswagen Protects Virtual Key Sharing App with Trustonic Application Protection22.2.2019 13:42:00 | Pressemelding
Volkswagen is working with mobile cyber security leader Trustonic to enable customers to use smartphones to access their vehicles, and to securely share their digital car keys to grant access to others via a smartphone app. Volkswagen is using the Trustonic Application Protection (TAP) platform to secure the mobile app and ensure that sensitive information and key transfer requests are securely displayed to, and approved by, a real authenticated user on a trusted device and not by hackers or malware simulating a user or device. “The smartphone is becoming the vehicle key of the future and our We Connect service is the interface for this today in the new Volkswagen Passat,” comments Alf Pollex, Head of Infotainment and Connected Car at Volkswagen AG. “The user installs the We Connect app on their smartphone which is then authorized via the infotainment system with a Transaction Number. The Mobile Key will be compatible with Android-based Samsung devices. No mobile network connection is
Mundipharma EDO GmbH: US FDA grants Orphan Drug Designation for etoposide toniribate in relapsed/refractory biliary tract cancer22.2.2019 13:30:00 | Pressemelding
Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted Orphan Drug Designation (ODD) to etoposide toniribate for the treatment of relapsed/refractory biliary tract cancer, also known as cholangiocarcinoma.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005126/en/ Biliary tract cancer is a rare tumour with approximately 8,000 patients diagnosed in the US every year and 10,571 in Europe.4,5 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Radical surgery is the only curative treatment for biliary tract cancer but, in most cases, the cancer is inoperable. Patients who fail first-line chemotherapy have limited treatment options and the standard of
Lenovo Data Center Group Delivers Broad Edge Computing Portfolio, Expands Investments in IoT22.2.2019 13:13:00 | Pressemelding
Next week at MWC Barcelona, Lenovo Data Center Group (DCG) will showcase continued investments in its solutions supporting IoT and edge computing as part of its IoT growth plan over the next few years. Building on the momentum of its fifth consecutive quarter of profit growth, Lenovo DCG is building a portfolio that takes infrastructure to where the data is, whether that be in the traditional data center, in the cloud or increasingly, at the edge. Today, around 10 percent of enterprise-generated data is created and processed outside a traditional centralized data center or cloud. By 2022, Gartner predicts this figure will reach 75 percent. This migration is driving increased concerns around data privacy, security and regulations coupled with challenges of latency, bandwidth and downtime. Lenovo is addressing these challenges by creating a broad portfolio of edge computing offerings that address the different ways that customers want to deploy edge computing solutions for IoT use cases.