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First patient enrolls in Phase II trial to evaluate vatelizumab


Genzyme has enrolled its first patient in a multicenter Phase II clinical trial to evaluate vatelizumab in patients with relapsing remitting multiple sclerosis. The trial, called EMPIRE, will assess the effectiveness, safety and tolerability of vatelizumab.

Vatelizumab is an antibody that targets VLA-2, a collagen-binding integrin expressed on activated lymphocytes. Vatelizumab is thought to block VLA-2 on activated immune cells, and thus may reduce the inflammatory cascade in MS.

“Continuous inflammation and neurodegeneration from the onset of multiple sclerosis can lead to significant disability,” said Eva Havrdova, M.D., Ph.D., MS Center, Department of Neurology, First Medical Faculty, Charles University, Prague. “The EMPIRE trial should enable us to assess vatelizumab’s ability to impact the acute inflammatory components of MS and evaluate its potential as an effective MS treatment.”

Genzyme is developing vatelizumab in MS in partnership with Glenmark Pharmaceuticals. EMPIRE is a global phase 2a/2b double-blind, randomized, placebo-controlled study assessing the effectiveness, safety and dose-response of vatelizumab in patients with active RRMS. The study duration is 12 weeks and is expected to enroll 168 patients at 55 sites in 10 countries.

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