Oral Multiple Sclerosis Drug Fingolimod Retains Effectiveness Over 3 Years: Presented at AAN

By Ed Susman

CHICAGO -- April 17, 2008 -- More than two thirds of patients with multiple sclerosis (MS) taking the experimental oral drug fingolimod (FTY720) have remained relapse free for at least 3 years, researchers reported here at the American Academy of Neurology (AAN) 60th Annual Meeting.

The sustained benefits of fingolimod were seen among patients in an open-label extension trial of a phase 2 trial of the drug, said investigator Giancarlo Comi, MD, Professor of Neurology, University Vita-Salute San Raffaele, Milan, Italy, in an oral presentation on April 15.

Fingolimod acts against inflammation by modulating sphingosine-1-phosphate receptors, reducing the number of inflammatory immune cells, called lymphocytes, from reaching the brain.

While several medications that appear to slow the progression of MS are now available, all are injected subcutaneously or intramuscularly.

"These new data demonstrate the exciting potential for FTY720 to reduce relapse rates in MS patients with a convenient once-daily pill," said Dr. Comi. "An effective oral treatment would be a significant breakthrough in the management of multiple sclerosis. That is why these results are encouraging -- because we are seeing substantial benefits of FTY720 maintained over time in this clinical trial."

In the study, Dr. Comi and colleagues enrolled 281 patients with relapsing MS into a 6-month, placebo-controlled phase in which patients received placebo, fingolimod 1.25 mg, or fingolimod 5 mg once daily. This was followed by a long-term extension phase in which all patients took fingolimod. At the end of 3 years, 173 patients were in the extension study. Dr. Comi said the study is continuing in Canada and 10 European countries.

"We observed that 73% of patients who began the study on fingolimod 5 mg remained free from relapses after 3 years and 68% of those who began the study on fingolimod 1.25 mg remained relapse free," Dr. Comi said. "The figures after 2 years of treatment were 77% and 75%, respectively."

"On the basis of comparable efficacy and a better safety profile, all patients have been transferred to fingolimod 1.25 mg in the study extension," he added.

After 3 years, the average yearly relapse rate was about 0.20 -- meaning that 1 relapse would occur in 1 patient in 5 years, Dr. Comi said. And 89% of patients were free of the active brain lesions characteristic of MS as measured by magnetic resonance imaging 3 years after starting treatment.

Among patients originally on placebo who converted to active therapy in the extension phase, 51% were free of relapses at 3 years, Dr. Comi said. After 2 years, 57% were free of relapse.

Dr. Comi said that skin malignancies were diagnosed in 7 patients among the original 281 patients in the study, and 8 more skin lesions have been observed in phase 3 studies involving another 3,000 patients. "We aren't really sure what to make of these malignancies," he said.

Because doctors have been alerted to scrutinise patients for these lesions, it is possible they have been seen because doctors are looking for them. So far all the lesions have been in situ cancers and have been excised without recurrence.

Novartis provided funding for the trial. The company expects to file for regulatory approval of the drug in 2009.

[Presentation title: Oral FTY720 (Fingolimod) in Patients With Relapsing Multiple Sclerosis. 3-Year Extension Shows Sustained Low Relapse Rate and MRI Activity. Abstract S12.005]

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