Multiple sclerosis studies halted after fatality

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March 29, 2005

Multiple sclerosis studies halted after fatality

Natalizumab withdrawn from clinical trials after being linked with rare

but deadly side-effect

A promising treatment for multiple sclerosis (MS) has been withdrawn

from clinical trials after being linked with two cases of a rare but

deadly nervous system disorder.

Natalizumab (brand name Tysabri) had been submitted for approval to

Health Canada following promising clinical trial results in MS,

rheumatoid arthritis and Crohn's disease. But developers Biogen Idec

and Elan Corporation recently suspended all clinical trails of the drug

because of safety concerns.

The drug had been linked with two cases of progressive multifocal

leukoencephalopathy (PML), a rare and often fatal disorder that occurs

mainly in people with a compromised immune system. It is caused by the

activation of a virus that resides in latent form in up to 80 per cent

of healthy adults. One of the patients has died.

" This was a great tragedy for the entire MS community because it has

put a huge damper on what was an extremely exciting and promising drug,

and we certainly hope that after the dust has cleared we will be able

to find a way to safely bring this drug back to patients. Of course,

that remains to be seen, " says Dr. , chief medical officer

for the U.S. National MS Society.

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