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Study shows Teva's laquinimod slows MS
LONDON (Reuters) - Teva Pharmaceutical Industries' multiple sclerosis pill laquinimod appears to slow the disease and is well-tolerated by people with the relapsing form of the incurable condition, researchers said on Friday.
The Phase II study of 306 people in nine countries included volunteers with the most common, relapsing-remitting form of the disease in which patients have varying levels of recovery and periods of remission between flare-ups.
"Overall, the efficacy and safety profile emerging from this and from a previous phase II clinical trial ... make laquinimod a promising therapeutic opportunity for patients," Giancarlo Comi, a researcher at the University of Vita-Salute, and colleagues wrote in the journal Lancet.
There is no cure for MS, which affects more than 1 million people worldwide. It is twice as common in women as men, with symptoms often first appearing between the ages of 20 and 40.
The disease can be a mild illness in some people while causing permanent disability in others. Symptoms may include numbness or weakness in one or more limbs, partial or complete loss of vision, tingling or pain, electric-shock sensations with certain head movements, tremors and an unsteady gait.
In their study, the Italian team found laquinimod showed a 40 percent reduction in the mean number of inflammatory lesions of the brain that are a hallmark of the disease, compared with a placebo.
When the researchers expanded their trial by a further 12 weeks, people showed a 60 percent median reduction in the number of brain lesions, a Teva spokesman said.
A lower dose showed no statistically significant effects versus the placebo but people taking the drug tolerated both amounts, the researchers added.
In an accompanying Lancet commentary, researchers from the Mayo Clinic in the United States wrote that the drug now needs to be tested head-to-head against other treatments to demonstrate it is better or at least as good an option.
"However, continued vigilance is needed because serious side effects are commonly not evident until phase III studies are started or until after approval," Mark Keegan and Brian Weinshenker wrote.
(Reporting by Michael Kahn; Editing by Quentin Bryar)
