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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ETreatment with the sphingosine 1-phosphate (S1P) receptor modulator, RPC1063, resulted in a substantial decrease in gadolinium-enhancing (Gd+) lesions and the number of new or enlarging T2 lesions in patients with relapsing-remitting multiple sclerosis (RRMS). This article presents data from the Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients trial [Radiance Study; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01628393\u0026amp;atom=%2Fspmdc%2F14%2F29%2F12.atom\u0022\u003ENCT01628393\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETreatment with the sphingosine 1-phosphate (S1P) receptor modulator, RPC1063, resulted in a substantial decrease in gadolinium-enhancing (Gd+) lesions and the number of new or enlarging T2 lesions in patients with relapsing-remitting multiple sclerosis (RRMS). Amit Bar-Or, MD, Montreal Neurological Institute, Montreal, Ontario, Canada, presented data from the Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients trial [Radiance Study; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01628393\u0026amp;atom=%2Fspmdc%2F14%2F29%2F12.atom\u0022\u003ENCT01628393\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ETargeting the S1P receptor family is an approach that has been explored as a treatment for patients with RRMS [Halmer R, Walter S, Fasbender K. \u003Cem\u003ECell Physiol Biochem\u003C\/em\u003E. 2014. RPC1063 is a novel agent that modulates S1P receptors 1 and 5, and has been previously evaluated in healthy subjects. The purpose of the Radiance Study was to further evaluate RPC1063 in patients with RRMS.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the phase 2 Radiance Study, 258 adult patients with RRMS were randomly assigned to receive 24 weeks of 0.5 mg or 1 mg of RPC1063, or placebo. Upon completion of the treatment period, a blinded extension study was conducted in which patients who received RPC1063 continued treatment, and patients who received placebo were assigned to 0.5 mg or 1 mg of RPC1063. Patients aged 18 to 55 were eligible to enroll in the study if they had an Expanded Disability Status Scale (EDSS) score of 0 to 5.0 at baseline and met \u2265 1 of the RRMS criteria, which included \u2265 1 documented relapse within the prior 12 months, or \u2265 1 documented relapse plus \u2265 1 Gd+ lesion(s) within the previous 24 months.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary end point of the Radiance Study was the cumulative number of Gd+ lesions. Secondary end points included the number of Gd+ lesions at week 24, the number of cumulative or enlarging T2 lesions, and the annualized relapse rate (ARR). At baseline, the mean EDSS score ranged from 2.85 to 2.94, the mean number of relapses over 12 months from 1.3 to 1.5, and the number of Gd+ lesions from 0.9 to 1.4.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe cumulative number of Gd+ lesions significantly decreased by 86% (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) in patients who received either dose of RPC1063 as compared with patients who received the placebo from week 12 to 24 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). In addition, at week 24, the mean number of Gd+ lesions significantly decreased by 91% and 94% (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001 for both) in patients who received 0.5 mg and 1 mg of RPC1063, respectively, as compared with patients who received the placebo. Similarly, the cumulative number of new or enlarging T2 lesions significantly decreased by 84% and 91% (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001 for both) in the 0.5 mg and 1 mg RPC1063 arms as compared with the placebo arm from week 12 to week 24. There was a dose-dependent trend toward a decrease in ARR, with a rate of 0.5 in the placebo arm, 0.35 in the 0.5-mg RPC1063 arm, and 0.24 in the 1-mg RPC1063 arm.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/29\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Effect of RPC1063 on Total Number of Gd+ Lesions Over 12 Weeks\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1521691867\u0022 data-figure-caption=\u0022Effect of RPC1063 on Total Number of Gd+ Lesions Over 12 Weeks\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/29\/12\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/29\/12\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/29\/12\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11859\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EEffect of RPC1063 on Total Number of Gd+ Lesions Over 12 Weeks\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EGd+, gadolinium-enhancing.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from JA Cohen, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EDuring the core, 24-week portion of the Radiance Study, the number of patients who experienced \u2265 1 treatment-emergent adverse event (TEAE) was 59.1% in the placebo arm, and 56% and 47% in the 0.5-mg and 1-mg RPC1063 arms, respectively. The most common TEAEs in patients who received RPC1063 included nasopharyngitis, headache, and urinary tract infection. During the study, 3 serious TEAEs were reported but deemed unrelated to the study drug. However, there were 3 cases of elevated alanine aminotransferase (\u2265 3 times the upper level of normal), but without associated clinical signs. There were no cases of discontinuation due to an AE.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EIn conclusion, Dr Cohen indicated that treatment of patients with RRMS with RPC1063 resulted in substantial reductions in magnetic resonance imaging measures and disease activity, with an overall good safety profile found with this phase 2 Radiance Study. A phase 3 portion of the Radiance Study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02047734\u0026amp;atom=%2Fspmdc%2F14%2F29%2F12.atom\u0022\u003ENCT02047734\u003C\/a\u003E] is ongoing and a phase 3 SUNBEAM trial, evaluating RPC1063 vs interferon beta-1a, is in the planning phase.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/29\/12.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzp7k1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp7k1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}