Results of a phase IIa clinical trial of an anti-inflammatory molecule, chaperonin 10, in multiple sclerosis

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dc.contributor.authorBroadley, S.
dc.contributor.authorVanags, D.
dc.contributor.authorWilliams, B.
dc.contributor.authorJohnson, B.
dc.contributor.authorFeeney, D.
dc.contributor.authorGriffiths, L.
dc.contributor.authorShakib, S.
dc.contributor.authorBrown, G.
dc.contributor.authorCoulthard, A.
dc.contributor.authorMullins, P.
dc.contributor.authorKneebone, C.
dc.date.issued2009
dc.description.abstract<h4>Background</h4>Chaperonin 10 (Cpn10) is a mitochondrial molecule involved in protein folding. The aim of this study was to determine the safety profile of Cpn10 in patients with multiple sclerosis (MS).<h4>Methods</h4>A total of 50 patients with relapse-remitting or secondary progressive MS were intravenously administered 5 mg or 10 mg of Cpn10 weekly for 12 weeks in a double-blind, randomized, placebo controlled, phase II trial. Clinical reviews, including Expanded Disability Status Scale and magnetic resonance imaging (MRI) with Gadolinium, were undertaken every 4 weeks. Stimulation of patient peripheral blood mononuclear cells with lipopolysaccharide ex vivo was used to measure the in vivo activity of Cpn10.<h4>Results</h4>No significant differences in the frequency of adverse events were seen between treatment and placebo arms. Leukocytes from both groups of Cpn10-treated patients produced significantly lower levels of critical proinflammatory cytokines. A trend toward improvement in new Gadolinium-enhancing lesions on MRI was observed, but this difference was not statistically significant. No differences in clinical outcome measures were seen.<h4>Conclusions</h4>Cpn10 is safe and well tolerated when administered to patients with MS for 3 months, however, a further extended phase II study primarily focused on efficacy is warranted.
dc.description.statementofresponsibilitySA Broadley, D Vanags, B Williams, B Johnson, D Feeney, L Griffiths, S Shakib, G Brown, A Coulthard, P Mullins and C Kneebone
dc.identifier.citationMultiple Sclerosis Journal, 2009; 15(3):329-336
dc.identifier.doi10.1177/1352458508099141
dc.identifier.issn1352-4585
dc.identifier.issn1477-0970
dc.identifier.orcidShakib, S. [0000-0002-7199-5733]
dc.identifier.urihttp://hdl.handle.net/2440/51600
dc.language.isoen
dc.publisherNature Publishing Group
dc.source.urihttps://doi.org/10.1177/1352458508099141
dc.subjectchaperonin 10
dc.subjectclinical trial
dc.subjectheat shock proteins
dc.subjectmultiple sclerosis [41]
dc.subjectrandomizedcontrolled (CONSORT agreement)
dc.subjecttreatment
dc.titleResults of a phase IIa clinical trial of an anti-inflammatory molecule, chaperonin 10, in multiple sclerosis
dc.typeJournal article
pubs.publication-statusPublished

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