Business Wire

Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS

16.9.2016 14:30 | Business Wire

Del

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results from the 96-week blinded extension period (for a total of up to 120 weeks of exposure on treatment) of the RADIANCE phase 2 trial of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS). The results were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which is being held in London from September 14-17, 2016.

“The data from this blinded extension are encouraging and further support evaluation of the benefit-risk profile of ozanimod in the ongoing phase 3 trials of patients with relapsing multiple sclerosis,” said Giancarlo Comi, MD, Professor of Neurology, Chairman of the Department of Neurology, and Director of the Institute of Experimental Neurology, at Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan.

As previously announced at ECTRIMS 2014, RADIANCE met its primary efficacy endpoint — reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions, as determined by MRI, from week 12 to week 24. In the blinded extension period of the study, patients originally randomized to ozanimod continued their assigned dose (0.5 mg, n = 85; 1 mg, n = 81), while patients in the placebo arm were randomized to either dose of ozanimod (0.5 mg, n = 41; 1 mg, n = 42). The extension week 96 visit was completed by 224 of the patients (90 percent) who entered the extension study.

At extension week 96, the mean number of GdE lesions was 0.3 for patients on the 0.5 mg dose and 0.1 for the 1 mg dose, compared with 0.4 and 0.1, respectively, at week 48. The proportion of patients who were free of GdE lesions was 91 percent for the 0.5 mg dose and 89 percent for the 1 mg dose. The cumulative number of new or enlarging T2-hyperintense lesions was 1.8 for the 0.5 mg dose and 0.6 for the 1 mg dose, compared with 1.3 and 0.7, respectively, at week 48.

The effect on unadjusted annualized relapse rate (uARR) was maintained in both ozanimod dose groups with uARR of 0.30 for the 0.5 mg dose and 0.19 for the 1 mg dose at extension week 96, and 0.26 and 0.15, respectively, at week 48.

No evidence of disease activity (NEDA: no GdE or new/enlarging T2 lesions, and no relapse or increase in Expanded Disability Status Scale [EDSS]) was achieved in 44 percent and 39 percent of patients at extension week 48 and 96, respectively, on the 0.5 mg dose and 62 percent and 47 percent on the 1 mg dose.

Reported treatment-emergent adverse events (AEs) were comparable across ozanimod dose groups; the most common reported AEs during the blinded extension (weeks 24 to 96) were minor infections (nasopharyngitis, respiratory tract and urinary tract) and headache. Alanine aminotransferase at least three times the upper limit of normal was reported in 11 patients (4.4 percent) through extension week 96. Consistent with extension week 48 data, no noteworthy occurrences of cardiac, pulmonary, serious opportunistic infections, ophthalmologic, or malignancy-related TEAEs were observed. No first-dose TEAEs of bradycardia of AV block ≥ 2nd degree were reported from day 1 of the study or day 1 of the extension.

“These 2-year safety and efficacy results further underscore the potential of ozanimod to offer a new oral therapeutic option for patients with this chronic condition. Based on these findings, and as part of our commitment to bringing innovative medicines to this patient community, we look forward to the continued study of this compound in the two ongoing pivotal phase 3 clinical trials in RMS,” said Scott Smith, President, Celgene Inflammation & Immunology.

About RADIANCE

The phase 2 portion of RADIANCE is a randomized, double-blind, placebo controlled study assessing the efficacy, safety and tolerability of two orally administered doses (0.5 mg and 1 mg) of ozanimod against placebo in 258 patients with relapsing multiple sclerosis across 55 sites in 13 countries, which was followed by a 2-year blinded extension period where all patients received ozanimod. The primary endpoint of the placebo–controlled trial is the reduction in the cumulative number of total GdE lesions determined by MRI from week 12 to week 24 of study treatment, a standard endpoint for phase 2 trials in relapsing multiple sclerosis. The secondary endpoints of the trial were: the number of GdE at week 24, the cumulative number of new or enlarging T2-hyperintense lesions at weeks 12–24, the annualized relapse rate from baseline until week 24 and safety and tolerability, as judged by the site investigator.

About Ozanimod

Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis and inflammatory bowel disease. Treatment with S1P receptor modulators is believed to work by interfering with S1P signaling and blocking the response of lymphocytes (a type of white blood cell) to exit signals from the lymph nodes, sequestering them within the nodes. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity by inhibiting migration of specific lymphocytes to sites of inflammation.

Ozanimod is an investigational compound that is not approved for any use in any country.

About Multiple Sclerosis

Multiple sclerosis 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 with severe multiple sclerosis may lose the ability to walk independently, while others experience long periods of remission during which they develop no new symptoms. Multiple sclerosis affects 400,000 people in the U.S. and approximately 2.5 million people worldwide.

Relapsing multiple sclerosis 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, and there is no apparent progression of disease. Relapsing multiple sclerosis is the most common disease course at the time of diagnosis. Approximately 85 percent of people are initially diagnosed with relapsing multiple sclerosis, compared with 10-15 percent with progressive forms of the disease.

About Celgene

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. 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 gene and protein regulation. 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 Corporation 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 other reports filed with the U.S. Securities and Exchange Commission.

###

Contact information

For inquiries, please contact:
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
or
Media:
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

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

Schlumberger Announces Third-Quarter 2017 Results Conference Call16.8.2017 21:23Pressemelding

Schlumberger Limited (NYSE:SLB) will hold a conference call on October 20, 2017 to discuss the results for the third quarter ending September 30, 2017. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call,

Rimini Street Named to Inc. 5000 List for Seventh Consecutive Year16.8.2017 18:20Pressemelding

Rimini Street, Inc., a global provider of enterprise software products and services, and the leading independent support provider for Oracle and SAP products, today announced that it was named to Inc. magazine’s 36th annual Inc. 5000 list for the seventh consecutive year. The Inc. 5000 list is an exclusive ranking of the nation’s fastest-growing private companies and represents the most comprehensive look at America’s entrepreneurs. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005908/en/ Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximately 2% – of Inc. 5000 honorees to ever achieve this milestone. (Photo: Business Wire) Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximatel

Keio Plaza Hotel Tokyo Starts "Ikebana" Flower Arrangement Workshops16.8.2017 14:00Pressemelding

Keio Plaza Hotel Tokyo, one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, starts special 45 minute classes to teach overseas guests about “Ikebana” flower arrangement which will be held on every other Thursday beginning from August in a private room for JPY3,000 per participant. Instruction and commentary will be provided by the renowned flower arrangement artist Hiroki Maeno. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005431/en/ From August, 2017, Keio Plaza Hotel Tokyo starts special 45 minute classes to teach overseas guests about "Ikebana" flower arrangement workshops. (Photo: Business Wire) Flower arrangement artist Hiroki Maeno has created special and unique flower arrangements for display in the main lobby of our hotel with each cha

Maxion Wheels to Feature Market Leading Commercial Vehicle Steel Wheels at COMTRANS 201716.8.2017 13:00Pressemelding

Maxion Wheels, the world’s largest wheel manufacturer, announced today its participation in the biennial COMTRANS / 17 International Commercial Vehicle Show held in Moscow, Russia from September 4 – 9, 2017, in Hall 15/ Stand 15-432. Customers and visitors to the Maxion Wheels exhibit will have the opportunity to learn more about the state-of-the-art commercial vehicle steel wheels that have supported the success of global original equipment manufacturers for almost 100 years. One of the key products on display will be the new 8.5” x 24” wheel for tubeless tire applications in Russia, the Middle East and Africa. The wheel boasts 15 percent less weight than the prior generation wheel, enhancing tire life and improving fuel efficiency. ABOUT MAXION WHEELS Maxion Wheels, a division of IOCHPE-MAXION S.A., is a leading wheel manufacturer for passenger cars,

Out-of-this-World Science Project to be Featured as Keynote at SC17’s High Performance Computing Conference in Denver16.8.2017 13:00Pressemelding

Professor Philip Diamond, Director General of the international Square Kilometer Array (SKA) project, will be the keynote speaker at SC17, the International Conference for High Performance Computing, Networking, Storage and Analysis in Denver, Nov. 12-17. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005129/en/ SC17 Keynote Speaker Philip Diamond (Photo: Business Wire) SKA is an international collaboration to build the world’s largest radio telescope that will change our understanding of space as we know it. Professor Diamond, accompanied by Dr. Rosie Bolton, SKA Regional Centre Project Scientist, will take SC17 attendees around the globe and out into the deepest reaches of the observable universe as they describe the SKA’s international partnership that will map and study the e

Scientist.com Ranks No. 155 on the 2017 Inc. 5000 List of Fastest-Growing Companies16.8.2017 12:06Pressemelding

Scientist.com, the leading marketplace for outsourced scientific services, today announced that it ranked no. 155 on Inc. magazine’s 2017 List of the 5000 Fastest-Growing privately-owned companies in America, and it ranked no. 11 in the country in the Health category. The San Diego-based company builds private marketplaces that connect many of the world’s largest life science research organizations with a global network of thousands of research suppliers. “Using Scientist.com, research organizations of pharmaceutical companies, biotech start-ups and academic and research institutes can get near instant access to thousands of the latest research technologies and services,” stated Paul A. Stone, JD, Partner at 5AM Ventures, a Scientist.com investor. “The marketplace saves researchers time, reduces costs, promotes access to innovation and ensures regulatory compliance. Scientist.com is im

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom