Good News for Oral MS Drug Fingolimod
70% of Multiple Sclerosis Patients Are Relapse-Free After 3 Years on Fingolimod
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Fingolimod Safety Good So Far, but Not Assured continued...
Like Tysabri, fingolimod suppresses the autoimmune responses thought to cause MS. In MS, haywire T lymphocytes -- the cellular generals of the immune system -- order attacks on the myelin sheaths that surround and protect the brain cells.
Tysabri is an engineered antibody that inactivates T cells. Fingolimod is a molecule that deprives T cells of the signal they need to leave lymph nodes, effectively stranding them outside the brain. It was originally designed to help prevent organ rejection in transplant patients, but that didn't work out very well, Aradhye says.
"Fingolimod is a gentle immunomodulator, which for a disease like MS is actually better than a strong one," Aradhye tells WebMD. "We have not seen anything to suggest that it results in serious opportunistic infections. Fingolimod is not destroying the lymphocytes, just keeping them away. Lymphocytes left in body tissues are able to do what they normally do. And while we have seen mild infections -- minor colds and coughs -- infection rates have not increased over time."
Even so, Aradhye warns that fingolimod is a potent inhibitor of immune responses and that patients are being watched carefully as they continue in the study. Three large phase III, placebo-controlled clinical trials are beginning, with a 1,000-patient U.S. study still recruiting patients. All patients in these studies will receive regular examinations by a dermatologist to ensure that if skin cancers occur, they will be detected early.
And researchers will continue to see what happens to patients in the current study as they continue on the drug.
"We are developing a new molecule, with a new biology, so it is important to see what happens, in terms of safety, in the core study over time," Aradhye says.
Aradhye hopes to have early results from phase III studies by early 2009 -- and hopes to have enough data to file for FDA approval by the end of that year.
"It is a privilege to work on something with the potential to be an oral agent with great efficacy for MS," he says. "We hope to have the data available in good time. But first we have to get though the phase III program."
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