Data from the extension of a Phase II study to 12 months confirmed the effects of FTY720, a new immunomodulator, for the treatment of patients with relapsing multiple sclerosis ( MS ).

The data, presented at the ECTRIMS/ACTRIMS meeting in Thessalonica, Greece, showed that both patient groups taking FTY720 ( 1.25 mg and 5 mg ) who had experienced a reduction in their annualized relapse rate of more than 50% during the first six months of the study compared to placebo maintained this low relapse rate during the subsequent six-month extension.

In patients who switched from placebo to either the 1.25 mg or 5 mg dosing of FTY720 after six months, the annualized relapse rate was reduced by at least 70% during the second six-month study phase compared to the first six months on placebo.

More than 80% of patients who received FTY720 for up to 12 months were free from lesions showing active inflammation on magnetic resonance imaging ( MRI ) at month twelve irrespective of their FTY720 treatment dose ( 1.25 mg or 5 mg ).

Based on the positive Phase II study results, Novartis is in discussions with regulatory authorities about the FTY720 Phase III program, which is expected to be launched by the end of 2005.
The Phase II study was conducted at 32 centers in 11 countries ( Europe and Canada ).
In the initial, placebo-controlled part of this study, 281 patients were randomized in equal numbers to receive either placebo, 1.25 mg or 5.0 mg FTY720 orally once-daily for six months.
After six months, patients in the placebo group were re-randomized to receive either FTY720 1.25 mg or 5 mg blinded for an additional six months, while patients already on FTY720 continued their originally-assigned treatment.
A total of 98% of the 255 patients who completed the first six months volunteered to continue in the extension phase evaluating the longer-term effects of FTY720.

FTY720 appeared to be well tolerated, with 91% of patients who entered the extension phase completing the 12th month on the study drug.
There were no unexpected safety findings during the extension as compared to the six-month placebo-controlled phase.
The most frequently reported adverse events in patients treated up to twelve months were non-serious infections ( colds, influenza ), headache, diarrhoea and nausea.

Oral FTY720 has a novel mode of action different from all available therapies. It reversibly sequesters lymphocytes away from blood and susceptible target organs such as the central nervous system ( CNS ), thereby reducing neuroinflammation in multiple sclerosis.

Source: Novartis, 2005


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