A board to discuss future MS therapies in early stage (Phase I or II) trials.


Postby bromley » Fri Oct 19, 2007 2:35 am

Not particularly impressive results:

Chaperonin 10 Shows Improvements in New Lesions in Patients With Multiple Sclerosis 19 October 2007

Intravenous administration of the mitochondrial chaperone protein chaperonin 10 is safe and well tolerated, and shows a decrease in new lesions in patients with multiple sclerosis (MS), according to a study presented here at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Principal investigator Simon Broadley, MD, PhD, Associate Professor of Neurology, Department of Medicine, Griffith University, Gold Coast City, United States, discussed the findings of the study in a presentation.

"Chaperonin 10 was originally known as an early pregnancy factor, as it was discovered as one of the factors in pregnancy that was thought to induce immune tolerance during pregnancy. And it was then found to improve the outcome in experimental models of multiple sclerosis."

Subsequently, it was shown to be identical to heat-shock protein Hsp10, and it is now known as chaperonin 10. In its role as a chaperone, chaperonin 10 is thought to be involved in the mitochondrial protein folding. Furthermore, it has a protective effect in experimental autoimmune encephalomyelitis, with suppression of the proinflammatory cytokines and chemokines, and it has been safely given to healthy subjects and patients with MS.

This randomised, double-blind, placebo-controlled, phase 2 study consisted of a 4-week lead-in, a 12-week treatment period, and a 4-week exit evaluation after completion of treatment. Clinical assessments, including Expanded Disability Status Scale (EDSS), and magnetic resonance imaging (MRI) were undertaken every 4 weeks.

Of 73 patients with relapsing-remitting (RRMS) or secondary progressive (SPMS) who were screened, 11 patients were randomized to receive placebo twice weekly and 20 received IV chaperonin 10 at a dose of 5 mg twice weekly, and 15 patients received chaperonin 10 at a dose of 5 mg once weekly plus placebo once weekly, both IV.

Chaperonin 10 was well tolerated and safe when administered at these doses.

No significant changes were seen in mean EDSS scores comparing the baseline score with the 12-week score in the placebo group (3.8 vs 3.8, respectively), placebo/chaperonin 10 group (3.2 vs 3.3) and chaperonin 10 group (3.8 vs 3.8). Similarly, there were no significant differences in relapse rate and MS impact scale (MSIS)-29 across the three treatment groups.

Dr. Broadley noted, however, "We saw this very slight hint of reduced Gd-enhancing lesions in the two treatment arms versus a slight increase in the placebo group, although it was not statistically significant."

Thus, although there were no significant differences seen in the clinical outcome measures across the three treatment groups, the researchers observed the expected pattern of changes in cytokine profiles in the active-treatment arms.

Therefore, intravenous chaperonin 10 appears to be safe and well tolerated, and shows a trend towards a reduction in MRI activity. Dr. Broadley also noted that a recent investigation of chaperonin 10 as rescue therapy in patients with rheumatoid arthritis showed promising results, with improvements in clinical measures of disease activity.

With this early promise for chaperonin 10, it now appears likely that investigations for patients with MS should continue, making use of improved dosing and administration routes that should arise from continued trials of chaperonin 10 for patients with rheumatoid arthritis, according to the researchers.

Funding for this study was provided by C-Bio.

Source: Presentation title: A Multicentre, Phase 2a Clinical Trial of chaperonin 10 in Multiple Sclerosis. Abstract P554 (19/10/07)
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