Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS
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.
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.
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.
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.
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.
For inquiries, please contact:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
Catherine Cantone, 908-897-4256
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
Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar15.12.2017 22:13 | Pressemelding
Celltrion, Inc. (KOSDAQ: 068270) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The CHMP’s opinion will now be sent to the European Commission (EC) for final review. Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in
Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease15.12.2017 12:34 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel). Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.2 This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/201712
Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards15.12.2017 12:21 | Pressemelding
Bitcoin Romania, leading Eastern European Bitcoin exchange & brokerage firm, and Twispay, Swiss-owned European payment processor and FinTech pioneer, today announced the availability of a payment integration that allows a global clientele to acquire Bitcoin and Ethereum cryptocurrencies using Visa and Mastercard bank cards. Unprecedented in Romania, this is one of the first East-Central European integration partnerships that allow consumers to use their cards to purchase cryptocurrency. Until recently, investors could only acquire cryptocurrencies through bank transfers and cash deposits, but the volatility of cryptocurrency markets dictates the need for additional operational flexibility. Investors require faster, safer, more reliable, and more comfortable ways to complete purchases. “One minute can make the difference between a million lost and a million earned. That is pr
Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 11:38 | Pressemelding
A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L
Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million15.12.2017 11:00 | Pressemelding
Global real estate investment company Kennedy Wilson (NYSE: KW) announces that it has acquired Northbank Apartments, a wholly-owned 124-unit apartment community in Dublin’s North Docks, for €45 million from Jarmar Properties Limited (In Receivership) acting through David Carson of Deloitte as Statutory Receiver, the lender being the National Asset Management Agency (“NAMA”). Situated in Dublin’s North Docks, Northbank is located just 50 meters from Kennedy Wilson’s existing 84-unit Liffey Trust apartments. The two buildings benefit from great transport links as the LUAS Red line is immediately adjacent connecting to Dublin’s city centre and main train stations in five minutes. “The successful acquisition of Northbank in such close proximity to our Liffey Trust asset allows us to leverage our existing presence and implement our value-add asset management strategy, including a
AML BitCoin Enters Phase II of ICO15.12.2017 09:00 | Pressemelding
NAC Foundation, LLC announces today that the initial coin offering for the AML BitCoin – the world’s only patent-pending compliant digital currency – has been extended for another month to accommodate a torrent of last minute, new coin purchasers and the demands of thousands of current owners of the coin, who have had difficulty navigating the process of establishing the specialized wallet required to hold the innovative digital currency. This second phase of the AML BitCoin initial coin offering will see an increase in the price of the coin, from US $1.00 to US $1.25. The company has already been contacted by prospective purchasers in the slightly higher priced Phase II, and anticipates a further price increase to US $1.50 within a week or two. HitBTC, one of the world’s largest and most active digital currency exchanges, was prepared to list the AML BitCoin for trading on
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom