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news.Serono and Ivax Corporation have revealed plans to initiate a phase III study with multiple sclerosis treatment Mylinax, a proprietary oral formulation of cladribine, in the first quarter of 2005.
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This multi-center, multi-national study is designed to assess the effectiveness of Mylinax in patients with relapsing forms of multiple sclerosis. Endpoints will include assessments of clinical relapses, disability progression and MRI (magnetic resonance imaging) brain scans. It will be a two-year, double-blind, placebo-controlled study involving over 1,200 patients.
“With the initiation of the phase III program of Mylinax, we are getting closer to realizing our objective to bring the first oral disease-modifying treatment to people with multiple sclerosis,” said Ernesto Bertarelli, CEO of Serono.
Previous clinical trials using a parenteral formulation demonstrated positive effects of cladribine administered via injection in patients with multiple sclerosis. In these trials, reduction in new lesion development in the brain as seen on MRI scans and clinical benefits were observed.
Mylinax is being developed by Serono and IVAX under a worldwide agreement signed in October 2002.