Serono and Ivax Corporation will initiate a phase III study with Mylinax (a proprietary oral formulation of cladribine) in the first quarter of 2005, the companies announced here.

This multi-centre, 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.

Ernesto Bertarelli, CEO of Serono said, " With the initiation of the phase III programme of Mylinax, we are getting closer to realizing our objective to bring the first oral disease-modifying treatment to people with multiple sclerosis."

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.

Cladribine is a purine nucleoside analogue that interferes with the behaviour and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis. Through its differentiated mechanism of action, Mylinax may offer an alternative option to patients with multiple sclerosis.