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Serious Infections – One Fatal – Experienced by Two People Participating in Clinical Trials of FTY720 for MS

Jun 06, 2008

Serious Infections – One Fatal – Experienced by Two People Participating in Clinical Trials of FTY720 for MS

Two people participating in clinical trials of the experimental oral medication FTY720 (Novartis Pharmaceuticals Corp.) for the treatment of multiple sclerosis were reported to develop severe infections – one of which was fatal. Our sympathies go out to the families of these individuals.

Background:This drug is in phase 3 studies after showing promise in earlier studies. There are approximately 3,000 people enrolled in multiple studies worldwide. This tragic report raises concern, and we understand that the sponsor is doing a full evaluation of the issue and trying to determine the role that the drug may have played in the infections. Both cases involved confounding factors, including the use of very high doses of steroids in one patient and the delayed use of antiviral therapy in the other.

Current Actions Underway:The independent safety monitoring committee overseeing the clinical trials has recommended that the trials proceed. Participants will be informed of the occurrence of these infections and will be asked to give their consent again to continue in the study. In addition, Novartis states that it is in active discussions with health authorities and other experts to develop measures that will enhance patient and investigator awareness regarding the risk of infections and how these risks may be reduced.

All individuals participating in clinical trials of FTY720 are advised to contact their study coordinators for more information. In the United States, a list of study sites and their contact information can be found at this Web site:http://www.msclinicaltrials.com/study_sites.html.

Since MS is driven by immune system attacks, researchers have to strike a difficult balance of turning down the MS attack without stifling the immune system’s ability to fight infection. We hope that further safety measures will reduce the risks of such events.