Serono and IVAX to Initiate Phase III Clinical Trial of Mylinax(R) in Multiple Sclerosis
January 11, 2005 - PRNewswire-FirstCall - Serono and IVAX Corporation announced today that they will initiate a Phase III study with Mylinax(R) (a proprietary oral formulation of cladribine) in the first quarter of 2005. This multi-center, multi-national study is designed to assess the effectiveness of Mylinax(R) 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.
"As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with multiple sclerosis," said Ernesto Bertarelli, CEO of Serono. "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."
"We are very pleased to have reached this important milestone in the development of Mylinax® as a novel therapy for multiple sclerosis," said Dr. Phillip Frost, Chairman and CEO of IVAX Corporation. "The initiation of this Phase III study supports our belief in Mylinax® and our choice of Serono as a partner that could help maximize its potential."
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 behavior 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.