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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\u003EIn patients with relapsing-remitting multiple sclerosis (RRMS), bimonthly injection with low-dose aB-crystallin (HspB5) resulted in a decrease in gadolinium-enhancing (Gd+) lesions and clinical relapses as compared with the placebo. This article presents data from a randomized study [2011-004475-36; van Noort JM et al. ACTRIMS\/ECTRIMS 2014 (poster P082)] that evaluated HspB5 for the treatment of RRMS.\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\u003EIn patients with relapsing-remitting multiple sclerosis (RRMS), bimonthly injection with low-dose \u03b1B-crystallin (HspB5) resulted in a decrease in gadolinium-enhancing (Gd+) lesions and clinical relapses as compared with the placebo. Hans van Noort, PhD, Delta Crystallon, Leiden, the Netherlands, presented data from a randomized study [2011-00447536; van Noort JM et al. ACTRIMS\/ECTRIMS 2014 (poster P082)] that evaluated HspB5 for the treatment of RRMS.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe oligodendrocytes of patients with MS have high levels of HspB5, a glial stress protein that initiates local anti-inflammatory, neuroprotective, and tolerogenic innate responses [van Noort JM et al. \u003Cem\u003EJ Neuropathol Exp Neurol\u003C\/em\u003E. 2010; Ousman SS et al. \u003Cem\u003ENature\u003C\/em\u003E. 2007]. However, interferon-gamma-secreting Th1 memory cells that target HspB5 exist [van Noort JM et al, \u003Cem\u003ENature\u003C\/em\u003E. 1995; Ousman SS et al. \u003Cem\u003ENature\u003C\/em\u003E. 2007; Bajramovi\u0107 JJ et al. \u003Cem\u003EJ Immunol\u003C\/em\u003E. 2000], which results in interferon-gamma-induced tissue damage [Bsibsi M et al. \u003Cem\u003EActa Neuropathol\u003C\/em\u003E. 2014]. In a previous Phase 1 study, administration of a single injection of HspB5 to healthy subjects led to an antigen-specific decrease in T-cell responses. The purpose of this study was to further evaluate low doses of HspB5 in patients with RRMS.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn this double-blind phase 2a trial, 32 patients with RRMS were randomly assigned in a 1:1:1:1 fashion to receive 7.5, 12.5, or 17.5 mg of HspB5 or placebo, with follow-up continuing until 48 weeks. HspB5 was administered as 3 bimonthly intravenous injections given at the beginning of the study (week 0), and at week 8 and week 16. At baseline, among the 4 study arms, the mean Extended Disability Severity Scale (EDSS) score ranged from 3.13 to 3.81, the mean number of relapses over the past 2 years from 1.75 to 2.25, and the mean time since the last relapse from 3.32 to 4.23 months.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn patients who received HspB5, there was a trend toward a decrease in Gd+ T1 lesions in all HspB5 arms, as determined by magnetic resonance imaging (MRI), with the 7.5-mg dose of HspB5 resulting in a significant reduction (\u003Cem\u003EP\u003C\/em\u003E = .017) over 36 weeks. When the data from the 7.5-mg and 12.5-mg HspB5 groups were combined, the MRI lesion load decreased by 75% at 36 weeks (\u003Cem\u003EP\u003C\/em\u003E = .0105; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) compared with the placebo. After the last dose of HspB5 administered at 16 weeks, the reduction in MRI lesion load continued for 20 weeks. In addition, there was a similar reduction in the frequency of clinical relapses over the 36 weeks among the treatment arms. All doses of HspB5 were safe and well tolerated.\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\/16\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Effect of HspB5 Injection on MRI Lesion Load in RRMS\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2015346837\u0022 data-figure-caption=\u0022Effect of HspB5 Injection on MRI Lesion Load in RRMS\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\/16\/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\/16\/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\/16\/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\/11863\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-6\u0022 class=\u0022first-child\u0022\u003EEffect of HspB5 Injection on MRI Lesion Load in RRMS\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EHspB5, alpha B-crystallin; Gd+, gadolinium-enhancing; MRI, magnetic resonance imaging; RRMS, relapsing-remitting multiple sclerosis.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from JM van Noort, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EIn conclusion, the results of this trial suggest that low-dose HspB5 is safe and well tolerated and may be effective in reducing MRI lesions and clinical relapses in patients with RRMS.\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\/16.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"}