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

¹ School of Medicine, Gold Coast Campus, Griffith University, Queensland, Australia; Gold Coast Hospital, Southport, Queensland, Australia
² CBio Ltd, Eight Miles Plains, Queensland, Australia
³ School of Medicine, Gold Coast Campus, Griffith University, Queensland, Australia
⁴ Royal Adelaide Hospital, North Terrace, Adelaide, Australia
⁵ Department of Digital Imaging, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; University of Queensland, St Lucia, Queensland, Australia
⁶ Department of Statistics, University of Auckland, Auckland, New Zealand

^* To whom correspondence should be addressed.

	Abstract

Background

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).

Methods

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.

Results

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.

Conclusions

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.

Key Words: chaperonin 10, clinical trial, heat shock proteins, multiple sclerosis [41], randomized controlled (CONSORT agreement), treatment

First published on November 27, 2008, doi:10.1177/1352458508099141

Multiple Sclerosis 2009;15:329.

A more recent version of this article appeared on March 1, 2009


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