FTY720 trial continues despite death
05 June 2008
Fingolimod (FTY720) is currently being investigated to evaluate further its effectiveness and safety in the treatment of relapsing remitting MS. The phase III trials include three studies involving more than 3,000 people with MS.
FTY720 reduces the number of immune cells, called lymphocytes, circulating in the blood stream by reversibly trapping a proportion of them in the lymph nodes. Consequently, the number of activated lymphocytes reaching the brain is reduced.
Most components of the normal immune response remain intact during treatment with FTY720. However, there is some reduction in the ability of lymphocytes to return to sites of infection. The ongoing Phase III clinical program in MS will add further information on the impact of FTY720 on the risk of infections.
Most components of the normal immune response remain intact during treatment with FTY720. However, there is some reduction in the ability of lymphocytes to return to sites of infection. The ongoing Phase III clinical program in MS will add further information on the impact of FTY720 on the risk of infections.
Recent developments
Recently two serious infections were reported in the clinical trials. One person with MS died from a disseminated varicella infection (chickenpox infection that spreads to organs in the body) and another person with MS developed a life-threatening herpes encephalitis infection (brain inflammation caused by herpes simplex virus-1).Both cases involved confounding factors, including the use of very high doses of steroids in the first person and the delayed use of antiviral therapy in the second person.
A similar clinical course and severity of these infection have been observed in patients who do not have MS, who were not involved in these trials and who were not treated with FTY720. Nevertheless it cannot be excluded that FTY720 played a role as the drug's mode of action leads to suppression of the body’s immune system, which can increase the risk of various infections.
What happens now?
After review of the cases by the independent Data Safety Monitoring Board (DSMB), it was recommended that the FTY720 clinical trials in Multiple Sclerosis continue as planned.Novartis is in active discussions with internal and external experts to further develop measures to enhance patient and investigator awareness regarding risk of infections and how these risks may be reduced. Clinical trial investigators and Health Authorities of those countries where FTY720 trials are being conducted have been notified of the cases.
