Dr Mark Freedman wrote:One other oral therapy that was curious is the novel agent called oral fumarate, deemed BG00012 by the company developing it. This agent evolves from the psoriasis world where it has been tested for some time.
Kappos and colleagues did a standard 24-week study in patients who had early disease; they had to have at least 1 attack in the last year, and at least 1 or more enhancing lesions. They tested placebo and 3 different drug levels: 120 mg once a day, 120 mg 3 times a day, or 240 mg 3 times a day. Then, all patients received BG00012 during a 24-week dose-blinded safety-extension period. Patients had a 69% reduction in the total number of gadolinium-enhancing lesions at weeks 12-24 and a reduction in the number of new and enlarging T2-hyperintense and T1-hypointense lesions. The largest effect was seen with the 240-mg 3 times a day dose. It appears that these results are encouraging enough to proceed into phase 3 testing.
Therefore, BG00012, teriflunomide, fingolimod, and cladribine are now in phase 3 trials. This means that we now have 4 oral therapies in phase 3 trials, so potentially by the end of this first decade of the millennium, we may have a number of oral therapies for MS, if they all prove to be successful.
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