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

School of Medicine, Gold Coast Campus, Griffith University, Queensland, Australia; Gold Coast Hospital, Southport, Queensland, Australia simon.broadley{at}griffith.edu.au

D Vanags

CBio Ltd, Eight Miles Plains, Queensland, Australia

B Williams

CBio Ltd, Eight Miles Plains, Queensland, Australia

B Johnson

CBio Ltd, Eight Miles Plains, Queensland, Australia

D Feeney

CBio Ltd, Eight Miles Plains, Queensland, Australia

L Griffiths

School of Medicine, Gold Coast Campus, Griffith University, Queensland, Australia

S Shakib

Royal Adelaide Hospital, North Terrace, Adelaide, Australia

G Brown

Royal Adelaide Hospital, North Terrace, Adelaide, Australia

A Coulthard

Department of Digital Imaging, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia; University of Queensland, St Lucia, Queensland, Australia

P Mullins

Department of Statistics, University of Auckland, Auckland, New Zealand

C Kneebone

Royal Adelaide Hospital, North Terrace, Adelaide, Australia

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

This version was published on March 1, 2009

Multiple Sclerosis, Vol. 15, No. 3, 329-336 (2009)
DOI: 10.1177/1352458508099141


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