Patient Enrollment Begins for Phase III Novel MS Drug
Posted on: Wednesday, 2 May 2007, 06:00 CDT
The Roskamp Institute has started to screen patients for enrollment in a new Novartis-sponsored phase III study to evaluate the efficacy and safety of multiple sclerosis drug FTY720.
FTY720 (fingolimod) is a novel, investigational, once-daily, oral medication, in relapsing-remitting multiple sclerosis (RRMS). The 12-month, double-blind, randomized, active-comparator study will include approximately 1275 MS patients in more than 170 study centers worldwide.
Principal investigator, Dr Andrew Keegan, said: "If the phase III study program confirms the data demonstrated in the phase II study program and leads to FDA approval, FTY720 may represent an improvement when compared to currently-available injectable medications."
In MS, inflammatory lymphocytes (T-cells) are believed to be responsible for the destruction of the protective myelin coating, which surrounds the nerves in key areas of the brain and spinal cord. This destruction hinders the ability of nerves to send electrical signals, resulting in problems with muscle movement, coordination, balance and cognition.
FTY720 has a novel mode of action different from all available therapies. It binds to the sphingosine 1-phosphate receptor-1 (S1P1) on circulating lymphocytes and reversibly traps a proportion of them in the lymph nodes. As a result, FTY720 lowers the number of activated T-cells circulating in the bloodstream and central nervous system.
Source: Datamonitor
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