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What research is being done for relapsing-remitting multiple sclerosis?

Positive topline results have been reported from CONFIRM, the second of two pivotal phase III clinical trials designed to evaluate the investigational oral compound BG­12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 milligrams of BG­12, administered twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and Biogen Idec, the company developing BG­12, anticipates presenting detailed data at a future medical meeting.

BG­12 met the CONFIRM study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44% for BID and by 51% for TID vs. placebo at two years. The CONFIRM study’s reference comparator, glatiramer acetate (GA; 20 milligrams subcutaneous daily injection), reduced the ARR by 29% compared with placebo at two years.

Initial results showed that BG­12 reduced 12­week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21% for BID and 24% for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7%.

In another study, treatment with high­yield process daclizumab, an investigational monoclonal antibody drug, cut annualized relapse rates in half among people with early RRMS in a placebo­controlled trial. Annualized relapse rates averaged 21% and 23% with two different dosage levels of daclizumab, compared with 46% for those put on placebo in the one­year, 600­participant trial known as SELECT. Daclizumab targets the CD25 molecule on CD4­positive T cells, which prevents them from interacting with interleukin­2. The result is a reduction in activated T cells and an increase in CD56­rich natural killer cell proliferation.

The SELECT trial, conducted in Europe and India, randomized the 600 participants in roughly equal numbers to subcutaneous injections of placebo or daclizumab, at 150 or 300 milligrams, given every four weeks for one year.

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