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Type: Journal article
Title: Results of a phase IIa clinical trial of an anti-inflammatory molecule, chaperonin 10, in multiple sclerosis
Author: Broadley, S.
Vanags, D.
Williams, B.
Johnson, B.
Feeney, D.
Griffiths, L.
Shakib, S.
Brown, G.
Coulthard, A.
Mullins, P.
Kneebone, C.
Citation: Multiple Sclerosis Journal, 2009; 15(3):329-336
Publisher: Nature Publishing Group
Issue Date: 2009
ISSN: 1352-4585
Statement of
SA Broadley, D Vanags, B Williams, B Johnson, D Feeney, L Griffiths, S Shakib, G Brown, A Coulthard, P Mullins and C Kneebone
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.
Keywords: chaperonin 10
clinical trial
heat shock proteins
multiple sclerosis [41]
randomizedcontrolled (CONSORT agreement)
DOI: 10.1177/1352458508099141
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Pharmacology publications

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