Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years:

Presented at ECTRIMS

By Bruce Sylvester

MADRID, SPAIN –

September 30, 2006 –

The investigative oral agent FTY720 (fingolimod) shows sustained clinical benefits for up to 2 years for patients with relapsing-remitting multiple sclerosis (RRMS), according to data from an extension of a phase 2 study presented here at the 22[nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). 

 "Notably, the relapse reduction rate of 50% and the inflammatory disease reduction rate of 80% that we saw at 6 months was sustained in this extension study," said lead investigator and presenter Ludwig Kappos, MD, head, Neurology-Neurosurgery Outpatients Clinics, University Hospital, Basel, Switzerland. 

 For the original 6-month, placebo-controlled phase 2 trial, Dr.  Kappos and colleagues enrolled 281 patients with RRMS.  Fingolimod significantly reduced magnetic resonance imaging (MRI) markers of inflammatory disease activity up to 80% and reduced relapses by more than 50% at both doses of 1.25 mg and 5 mg. 

 In the original trial, the annualized relapse rate was 0.77 for placebo versus 0.35 for the 1.25-mg fingolimod dose (P = .009) and 0.36 for the 5-mg fingolimod dose (P = .014). 

 The objective of the extension study was to report safety and efficacy results during 24 months of follow-up, the authors said. 

 For the extension, the researchers enrolled 250 of 255 subjects who completed the 6-month study.  Fingolimod subjects continued on their original dosing, and placebo subjects were re-randomized to both fingolimod dosing groups.  Each subject was evaluated at the beginning of the extension study and every 3 months thereafter.  Between month 15 and month 24 all subjects receiving 5 mg were switched to 1.25 mg. 

 "The extension is ongoing with all patients on 1.25 mg fingolimod," the investigators noted. 

 The researchers reported that the annualized relapse rate at month 24 was 0.20 in the continuous fingolimod group and 0.33 in the placebo- fingolimod groups (6 months on placebo and 18 months on fingolimod). 

 At month 24, 84% of patients in the continuous fingolimod and 85% in placebo-fingolimod showed no gadolinium-enhancing lesions, and 79% of patients on continuous fingolimod and 78% in the placebo-fingolimod groups were free of disability progression. 

 The authors noted that they found no unexpected adverse effects in subjects treated for up to 24 months compared with the 6-month cohort. 

 "These positive results support further evaluation of fingolimod as an oral treatment option in the ongoing phase III program in RRMS," they wrote. 

 "It appears that FTY720 might not only offer significant clinical benefits to patients but, as an oral agent, it could also serve to enhance compliance," Dr.  Kappos said. 

 "Large-scale, international phase 3 studies of the use of the drug in relapsing-remitting MS are now underway," he added. 

 The study was supported by Novartis Pharma AG. 

 [Presentation title: Oral Fingolimod (FTY720) in Relapsing Multiple Sclerosis: 24-Month Results of the Phase II Study.  Abstract P376]