Fingolimod Effective to 24 Months in Relapsing MS.../MORE
October 10, 2006 (Chicago) — Results of an extension study with oral fingolimod in patients with relapsing multiple sclerosis (MS) continue to show reduced disease activity on MRI as well as low rates of relapse, in both patients who received the drug continuously through 24 months and patients who had been randomized to placebo during the main study and were switched to active drug after the study closed at 12 months.

"The summary is that there were no new side effects, and the effect was of the same level, so it confirms the results that we had in the first 12 months," lead author Ludwig Kappos, MD, from the University Hospital in Basel, Switzerland, told Medscape.

Main results of this phase 2 trial, supported by Novartis Pharma in Basel, Switzerland, were published in the September 14, 2006 issue of the New England Journal of Medicine (2006;355:1124-1140). Results of the extension trial out to 24 months were presented here at the American Neurological Association (ANA) 131st Annual Meeting.

Confirming Previous Findings

Fingolimod is a still-investigational drug that, given orally, acts as a superagonist to sphingosine-1-phosphate (S1P) receptors on the surface of thymocytes and lymphocytes, causing them to be sequestered in secondary lymph organs. This reduces the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS....

These positive results, the authors conclude, warrant continued investigation of the drug; the open-label extension continues, with all patients receiving the 1.25-mg dose of fingolimod.

"It has now entered phase 3, with 2 large studies, 1 comparing the drug with placebo for 2 years, and another comparing fingolimod with 1 of the approved interferons for 1 year" in relapsing MS patients, Dr. Kappos said. They will use the 1.25-mg dose, the authors note, and plan to evaluate an even lower dose of 0.5 mg....