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Small Edmonton-based clinical trial
shows some slowing of disease progression
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Medical Update Memo
June 23, 2006
Summary
A small phase II study by researchers at the University of Alberta has found
that the administration of an experimental drug called MBP8298 may slow the
progression of multiple sclerosis in some participants who have progressive
forms of MS and who have specific immune response genes. The findings
were published in the June 13, 2006 online version of the European Journal
of Neurology. A large, multi-centre phase III study is now underway.
Details
As reported in the June 13, 2006 online version of the European
Journal of Neurology. Dr. Kenneth Warren and Ingrid Catz
found the administration of the experimental drug MBP8298 delayed
the progression of MS in a subgroup of study participants for
five years compared to the group that received a placebo (non-active
substance). The researchers developed MBP8298 at the
University of Alberta.
A total of 32 people
with progressive MS (either secondary-progressive or primary-progressive)
were given MBP8208 or placebo intravenously (into a vein)
every six months for two years in this double-blind study
(neither the participants nor the examining physicians knew
who was receiving active drug or placebo). The
participants ranged from 3.0 (able to walk without assistance)
to 7.5 (can walk a few steps but needs a wheelchair for mobility)
on the standard Expanded Disability Status Scale (EDSS). The
overall result was that there was no significant difference
in progression between those who received MBP8298 and those
who received placebo.
When a subgroup
analysis was done taking into account the participants’ immune response genes, the investigators
found people with HLA haplotypes HLA-DR2 or HLA-DR4 showed
a statistically significant benefit of MBP8298 treatment compared
to participants with the same haplotypes who received placebo. HLA-DR2/DR4
haplotypes are found in 50-70 percent of people with MS compared
to 20-30 percent of the general population.
The researchers also measured whether MBP8298 suppressed antibodies
to myelin basic protein to determine the level of immune tolerance.
They found antibody suppression in most MBP8298 treated participants,
but antibody suppression was not predictable of any clinical
benefits.
MBP8298 is a synthetic
peptide that corresponds to a portion of the body’s own myelin basic protein, one of the proteins
that make up myelin, the vital protective covering of nerves
in the central nervous system. This sequence is thought
to be the main target of immune system cells during MS attacks.
By administering MBP8298, the researchers hope to restore immune
tolerance of this important myelin component.
A phase II/III
clinical trial of the use of MBP8298 in the treatment of
secondary-progressive MS is currently enrolling participants
in Canada, the United Kingdom, Denmark and Sweden. Approximately
550 participants will receive either MBP8298 or placebo intravenously
every six months for two years. BioMS, an Edmonton-based biotechnology
company, is sponsoring the study. For more information
about the study, see the BioMS website: www.biomsmedical.com
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or
therapy but provides information to assist individuals in making their own
decisions.
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