were reports on a number of clinical trials, mainly of oral agents which are summarized below.
Fingolimod: Further results from the TRANSFORMS study were reported. The initial
results were reported at AAN earlier this year. This was a large study with over 400 patients per arm, and fingolimod
was compared to interferon rather than using a placebo control. The effectiveness looks good with over a 50% reduction
in relapse rate. Safety is a concern, since there were 2 fatal virus infections in the treatment group.
Oral cladribine, further results from the CLARITY study. Again,
the initial results of this study were reported at the AAN, and it was a large study with over 400 patients in each group,
with cladribine compared to placebo. The relapse rate was reduced 58%, and MRI activity decreased 88%. No
safety concerns were identified, but they remain a concern with a cytotoxic drug like this.
BG12 or fumarate: This agent is earlier in the clinical trial process.
It reduced relapse rate by about 30% compared to placebo.
they reported safety results which look promising.
This is another oral agent with immunomodulatory effects. This was a phase II study with around 40 patients per arm,
and the drug was used as an add-on to interferon. MRI activity decreased by about 80%.
Atorvastatin in early MS: this is a cholesterol lowering drug, which may
also be useful in MS. They didn't enroll as many patients as they planned with only 82 total patients, and there wasn't
any obvious benefit.
Dirucotide: This is a
peptide from myelin basic protein, and it was used in a study with over 500 secondary progressive MS patients. There
was no benefit.
In summary, there are a number of
oral treatments in development, some of which may be more effective than our current standard treatments. The combination
of increased effectiveness and safety is elusive. The single trial in progressive MS was negative, but it is good to
see treatments being tried in progressive disease since the majority of drugs are for relapsing MS.