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Good News for Oral MS Drug Fingolimod

70% of Multiple Sclerosis Patients Are Relapse-Free After 3 Years on Fingolimod
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WebMD Health News

April 16, 2008 -- Seventy percent of multiple sclerosis patients taking the experimental drug FTY720 -- fingolimod -- were relapse free after three years of daily treatment.

The finding comes from an extended phase II clinical trial in which all patients receive the immunity-suppressing drug. Researchers Giancarlo Comi, MD, of San Raffaele Hospital in Milan, Italy, reported the findings at this week's meeting of the American Academy of Neurology in Chicago.

"The first-line treatments for MS ... reduce the relapse rate by only about 30%, so this is a significant development for people with MS," Comi says in a news release.

All current MS drugs must be administered by injection or infusion -- a huge disadvantage for patients, says neurologist Orly Avitzur, MD, medical advisor for Consumer Reports. Avitzur was not involved in the fingolimod study.

"This drug is completely different from any other on the market for MS," Avitzur tells WebMD. "It is the first oral MS drug to get this far, and if it is successful in large-scale clinical trials, it will make a huge difference in quality of life for MS patients."

In the phase II study, 173 patients with the relapsing form of MS (a type of MS that repeatedly relapses and has periods of recovery in between) received fingolimod for three years. More than 67% of the patients were free of relapses after three years, with an annual relapse rate of 0.2%, says Shreeram Aradhye, MD, vice president and senior global medical program director for Novartis, the company developing fingolimod.

"When you look at all the biologic treatments [medications that target the immune system to reduce the frequency and severity of attacks and reduce lesions within the brain] for MS, this 0.2% annualized relapse rate seems to be a new benchmark," Aradhye tells WebMD. "This was complemented by the encouraging observation that 89% of patients at year three have no evidence of inflammation in MRI brain scans [a sign of MS progression]."

Fingolimod Safety Good So Far, but Not Assured

So far, the most common side effects of fingolimod have been head colds, headache, and fatigue. But there have also been a few cases of skin cancer, which has also been reported in patients taking Tysabri, an approved MS drug.

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.

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