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Title: Long-Term Data for Fingolimod Show Significant Efficacy and Safety in Preventing MS Relapse: Presented at AAN

"Long-Term Data for Fingolimod Show Significant Efficacy and Safety in Preventing MS Relapse: Presented at AAN"

By Claire Sowerbutt SAN DIEGO, C.A. -- April 7, 2006 -- New data from a phase 2 study of FTY720, (fingolimod) show a better than 50% reduction in the annualised relapse rate in patients with relapsing-remitting multiple sclerosis (MS). The results were seen with 2 separate doses -- 1.25 mg/day and 5 mg/day -- of FTY270, an oral sphingosine-1 phosphate receptor modulator. "We are very encouraged to see that the effects of fingolimod in reducing both clinical relapses and inflammatory disease activity are maintained over 18 months," said Paul O'Connor, MD, chief, department of neurology, St. Michael's Hospital, associate professor, University of Toronto, Toronto, Ontario, Canada.'' Dr. O'Connor presented the data on April 4[^th at the 58^th Annual Meeting of the American Neurological Association (AAN).

In the 18-month study, researches enrolled 281 patients in 32 centres in 11 countries. They were randomised in a 1:1:1 fashion to placebo, 1.25 mg/day or 5 mg/day FTY270 for 6 months. Following the 6-month randomisation phase, patients on active treatment could choose to enter a 12-month extension phase and continue on their assigned dosages, and patients in the placebo group were rerandomised to either 1.25 mg/day or 5 mg/day of FTY720. At the end of 12 months participants receiving 5 mg/day continued on 1.25 mg/day of the drug.

The researchers measured disease activity using magnetic resonance imaging (MRI) and clinical relapses. They also evaluated the drug's tolerability and safety. Data from 277 patients were included in the intent-to-treat analysis.

"Patients who were originally on placebo and switched to study drug in the extension phase showed a pronounced reduction in relapse rates in either the 1.25- or 5-mg arms," Dr. O'Connor said. "Patients that were originally on the FTY720 drug maintained their lower relapse rates."

"MRI data for months 6 versus 12 show a dramatic reduction in the number of enhancing lesions in patients switched from placebo, which were statistically significant," Dr. O'Connor said.

Adverse events reported most frequently in patients treated for 18 months included non-life-threatening infections such as colds and influenza, and headache. There were increases in heart rate following administration of the first dose, as well as an increase in blood pressure, alteration in liver function, and mild increases in airway resistance. However, Dr. O'Connor said, these effects did not continue beyond 6 months.

FTY720 works by binding to the sphingosine 1-phosphate present on a proportion of circulating lymphocytes and reversibly trapping them in lymph nodes. This subsequently has the effect of reducing the number of activated circulating T-cells in the central nervous system and the blood stream.

Dr. O'Connor noted that FTY720 does not affect all components of normal lymphocyte function; therefore, they can be activated as part of the immune response within the lymph nodes and other tissues.

Results from the 24-month analysis are expected by the second half of 2006.

This study was supported by Novartis Pharma AG, Basel, Switzerland.

[Presentation title: Oral FTY720 in Relapsing MS: Results of the Dose-Blinded, Active Drug Extension Phase of a Phase II Study. Abstract S12.003]

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