NOVARTIS PUBLISHES FINDINGS FROM MS STUDY

Results recently published in the New England Journal of Medicine showed significant benefits for patients suffering from relapsing multiple sclerosis (MS) who were treated with Novartis' FTY720 (fingolimod), according to the company.

The Phase II trial showed that FTY720 taken once daily during the initial six months of treatment reduced the rate of inflammatory disease activity -- as measured by an MRI -- by up to 80 percent and cut clinical relapses by more than 50 percent compared with placebo.

In patients who continued taking FTY720 during the subsequent six-month extension, low levels of disease activity were maintained as measured by both MRI and relapses. Both these measures also decreased in patients who switched from placebo to FTY720.

The study was conducted at 32 centers in 11 countries to evaluate the effect of FTY720 on disease activity as well as safety and tolerability. In the initial placebo-controlled phase, 281 patients were randomized equally to receive FTY720 (1.25 mg or 5 mg) or placebo once daily for six months. Of the 255 patients who completed this part of the study, 98 percent volunteered to continue in the extension phase. Patients in the placebo group were then re-randomized to receive either 1.25 mg or 5 mg of FTY720 and were blinded for an additional six months. Those already on FTY720 continued with their original treatment.