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
Hot Wheels Teams Up With Nintendo to Bring the World of Mario Kart to Fans With New Die-cast Toy Line20.6.2019 13:00:00 CEST | Pressemelding
Today Hot Wheels and Nintendo announce the global release of Hot Wheels Mario Kart die-cast vehicles and track sets. With its introduction, the beloved Nintendo characters and iconic karts from the hugely popular Mario Kart franchise have been transformed into authentic, high-performance die-cast toy vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190620005167/en/ Three Hot Wheels Mario Kart game-inspired track sets will be available this summer. (Photo: Business Wire) The Hot Wheels replica line features 1:64th scale die-cast Mario Kart vehicles that can race, stunt and crash on a variety of Hot Wheels Mario Kart track sets that bring the gameplay to life. The die-cast karts are also compatible with existing Hot Wheels sets. At launch the Hot Wheels Mario Kart Replica Die-cast assortment will include Mario, Yoshi, Luigi and Bowser with many additional characters coming soon such as Princess Peach, Koopa Troopa and
Arch Capital Group Names Seamus Fearon EVP, Credit Risk Transfer and Services, Global Mortgage Group20.6.2019 13:00:00 CEST | Pressemelding
Arch Capital Group Ltd. (Arch) today announced that Seamus Fearon has been promoted to Executive Vice President, Credit Risk Transfer and Services, Global Mortgage Group. In this role, Fearon will have responsibility for managing Arch’s credit risk transfer (CRT) business and growing its credit risk services offerings. He most recently was Chief Actuary of Arch’s Global Mortgage Group, where he oversaw its capital management framework and the development of its analytics and modeling capabilities. This newly created role highlights Arch’s focus on participating in credit risk transfer programs and supporting customers who would like to enter that growing market. “As the mortgage insurance market in the U.S. becomes even more competitive, it’s important for Arch to diversify its mortgage business to ensure we remain at the forefront of the industry,” said David Gansberg, CEO of Arch’s Global Mortgage Group. “Seamus brings both an analytical perspective and business acumen to these units
Cargo Screening Technology by Smiths Detection at the Mega Tema Port Expansion in Ghana20.6.2019 11:22:00 CEST | Pressemelding
Smiths Detection has won a contract with Meridian Port Services Limited (MPS) to provide cargo inspection technology for the major Tema Port Expansion project in Ghana - designed to accommodate the world’s largest container ships, improve cargo handling productivity and increase trade to both Ghana and the rest of Africa. Four Smiths Detection HCVPZ60 scanning portals were selected to deliver the Ghanaian authorities more efficient border security, while safeguarding state revenue derived from duties and taxes on containerised goods. With trade anticipated to grow in Ghana in the coming years, these portals have been selected in part because of their ability to facilitate fast and effective security processing of a high volume of container traffic. The HCVPZ60 can penetrate 9-11.8 inches of steel whilst maintaining a throughput of up to 100 trucks per hour. Smiths Detection’s advanced screening technology, iCMORE will also be deployed, to expose containers falsely declared as empty. Th
Desktop Metal Now Shipping the World’s First Office-Friendly Metal 3D Printing System to Companies Throughout Europe20.6.2019 10:55:00 CEST | Pressemelding
Desktop Metal, the company committed to making metal 3D printing accessible to manufacturers and engineers, today announced it has begun shipping its Studio System™ to customers and resellers throughout Europe. The world’s first office-friendly metal 3D printing system for functional prototyping and low volume production, has met with strong adoption in North America among leading companies, including Ford, Stanley Black and Decker, Google’s ATAP, Goodyear, Owens Corning, and John Zink Hamworthy Combustion. Building on that momentum, the Studio System is now CE certified for international compatibility and being installed at customers throughout Europe, including France, Germany, Greece, Italy, Portugal, Spain, the Netherlands, and the United Kingdom. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190620005055/en/ Desktop Metal is now shipping the Studio System, the world’s first office-friendly metal 3D printing system, to
L’Oréal Rewards Social Initiatives Led by Dermatologists at World Congress of Dermatology in Milan20.6.2019 09:23:00 CEST | Pressemelding
In partnership with the International League of Dermatological Societies (ILDS) and the 24th World Congress of Dermatology (WCD), L’Oréal announced the laureates of the third International Awards for Social Responsibility in Dermatology: “Caring to Inspire Skin Confidence”. This aims to reward social initiatives led by dermatologists, improving patients’ physical and psychological well-being, self-esteem, social integration and skin health, and enabling patients to re-engage socially. Brigitte Liberman, President of L’Oréal’s Active Cosmetics Division, said: “Social responsibility is a priority for L’Oréal and we are proud to partner with the ILDS and the WCD to reward iconic dermatologists having positive actions on people’s lives”. Professor Harvey Lui, President of the ILDS, added: “Beyond the day-to-day activities of dermatologists in managing patients with skin issues, there is a vital social role, which is exemplified through our partnership for these awards and lies at the heart
First deployment of open-standard Identity Management interface OSIA in DRC20.6.2019 08:45:00 CEST | Pressemelding
IDEMIA, the global leader in Augmented Identity, in partnership with CIVIPOL, the technical cooperation operator of the French Ministry of the Interior, DIGITECH, a leading provider of paperless Civil Registry solutions, UNFPA, the United Nations Population Fund and CARITAS, a confederation of 165 Catholic relief, development and social service organizations, announces the first deployment of the open-standard Identity Management interface OSIA in the Democratic Republic of Congo (DRC). This World Bank funded project aims to register 2.4 million children and produce 600,000 birth certificates. The consortium led by CIVIPOL supports the ambitious goal set out by the United Nations General Assembly “One ID for all by 2030.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190620005047/en/ Credits : IDEMIA The consortium focusses on two project streams: the first stream concentrates on the enhancement of the current Civil Registr