Multiple sclerosis (MS) patients taking an experimental new daily pill have found that it worked equally well at controlling the condition in the second six months as it did in the first six months of a trial, pharmaceutical group Novartis has announced.
Novartis reports that the new pill, FTY720, has reduced the rate of relapses of patients by more than 50 per cent in the first six months of the trial and the rate has been maintained during the second six months, compared to a placebo. Current treatments for MS require frequent, deep injections and reduce relapse rates by around 30 per cent over two years.
More than two million people worldwide suffer from the neurological disease and many go on to develop the secondary progressive form of multiple sclerosis within ten years of diagnosis.
The pharmaceutical firm also found that patients who switched from placebo to either the 1.25mg or 5mg dosing of FTY720 after six months, saw annual relapse rates reduced by at least 70 per cent during the second six-month study phase. All patients saw a reduction in lesions as a result of the treatment.
The Phase II study took place at 32 centres in 11 countries and involved 281 patients. In a statement released at meeting in Thessalonica, Greece, Swiss-based Novartis intends to start final Phase III trials on its drug by the end of 2005.
Professor Ludwig Kappos from the Department of Neurology at the University Hospital in Basel, Switzerland, said: "We are excited by these full-year study results confirming the significant effect of oral FTY720 on reducing both clinical relapses and inflammatory disease activity that we first saw during the six-month placebo-controlled phase of the study. We hope that the magnitude of benefits shown in Phase II will be confirmed in the larger scale Phase III study program expected to be launched soon."