45 patients were recruited in phase 2
Authorities have accepted the transformation of phase 2 into phase 3, with a prospective recruitment of 210 patients
PARIS, Nov. 4, 2013 (GLOBE NEWSWIRE) -- AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces the initiation of a clinical development program with masitinib in the treatment of Amyotrophic Lateral Sclerosis (ALS).ALS is a rare degenerative disorder that results in progressive wasting and paralysis of voluntary muscles. There are approximately 30,000 people with ALS in the European Union (15,000 in the US) with more than 7,500 new cases developed each year (4,500 in the US). Almost 50% of ALS patients die within 3 years and 90% die within 5 years. The clinical development program of masitinib in ALS started with a phase 2 clinical study, which involved the recruitment of 45 patients. Health authorities agreed to transform the phase 2 study into phase 3, with prospective recruitment of 210 patients. The readout of this study is expected by the end of 2015. This study is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). Study treatment will be given as add-on therapy to patients who have been treated with a stable dose of riluzole. The study aims at evaluating the effect of masitinib on the functional impairment of patients assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS). Professor Olivier Hermine, President of the scientific committee of AB Science explained: "In this study, we assume that mast cells, which are key immune cells, actively participate to the pathogenesis of ALS, through the release of mediators that sustain the inflammatory network of the central nervous system. Mast cells, which are present in large quantities in the brain and in the spinal cord, could also influence the survival and functions of motor neurons, and thus participate to the pathophysiology of ALS. Since masitinib is a selective inhibitor of c-Kit and Lyn, two kinases that play a major role in the survival and activation of mast cells, it may lead to positive effects on the symptoms of the pathology."