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Experimental Drug Fights Multiple Sclerosis Activity
Date:6/20/2008

ated oral drug called Linomide (roquinimex) was stopped during Phase 3 trials when the compound was linked to a high incidence of heart problems, including heart attacks. The trial lasted long enough, however, to show that the drug had benefit, Richert said.

"That information served as impetus for researchers to go back to the laboratory and try to engineer out the cardiac toxic part of the molecule but maintain the immunomodulatory effects that were beneficial for an autoimmune disease like multiple sclerosis," Richert explained. "That is how laquinimod was born."

Laquinimod works by binding to receptors on immune cells, isolating them in the lymph nodes, thereby reducing their ability to cause the damage associated with MS symptoms.

The nine-country study involved 306 patients aged 18 to 50 who were randomly assigned to receive either a placebo, 0.3 milligrams of laquinimod or 0.6 milligrams of laquinimod daily.

People with the higher dose of laquinimod had a 40.4 percent reduction in the number of lesions -- indicating disease activity -- seen on MRI scans. The lower dose had no significant benefit.

There were two side effects, both of them reversible. Two patients stopped taking the drug because they developed liver problems, the researchers said.

A Phase 3 trial is currently under way, said the study authors, from the Institute of Experimental Neurology at the University Vita-Salute in Milan, Italy.

"Certainly there have been Phase 2 drugs that have looked OK that have failed in Phase 3," Richert said. "There's always a significant amount of guesswork in trying to predict how things are going to end up."

More information

Visit the National Multiple Sclerosis Society for more on this disease.



SOURCES: John Richert, M.D., executive vice president for re
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