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 progressiveMS 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.
RCT Entities:
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.
Authors: Maurizio Bellavia; Giovanni Tomasello; Marcello Romeo; Provvidenza Damiani; Attilio I Lo Monte; Luciano Lozio; Claudia Campanella; Antonella Marino Gammazza; Francesca Rappa; Giovanni Zummo; Massimo Cocchi; Everly Conway de Macario; Alberto J L Macario; Francesco Cappello Journal: Med Microbiol Immunol Date: 2013-07-18 Impact factor: 3.402
Authors: G Tomasello; C Sciumé; F Rappa; V Rodolico; M Zerilli; A Martorana; G Cicero; R De Luca; P Damiani; F M Accardo; M Romeo; F Farina; G Bonaventura; G Modica; G Zummo; E Conway de Macario; A J L Macario; F Cappello Journal: Eur J Histochem Date: 2011-10-24 Impact factor: 3.188
Authors: Abdulkarim M Alsultan; David Y Chin; Christopher B Howard; Christopher J de Bakker; Martina L Jones; Stephen M Mahler Journal: Sci Rep Date: 2016-11-22 Impact factor: 4.379