PARIS, Nov. 11, 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 that the independent Data and Safety Monitoring Board (DSMB) created as part of the company pivotal clinical study evaluating masitinib in the treatment of mastocytosis has recommended continuation of the study, based upon completion of the futility analysis included in the study protocol.
The objective in this phase 3 study is to compare the safety and efficacy of masitinib to placebo in adult patients with Indolent Systemic Mastocytosis with severe handicap at baseline.
The futility analysis was included in the clinical study design to ensure that the study could be stopped early if it appeared that the study would be eventually unable to demonstrate the efficacy of masitinib in the target population of patients with Indolent Systemic Mastocytosis with severe handicap at baseline.The analysis was performed with two-third of the target population to recruit. The futility analysis was performed by the independent Data and Safety Monitoring Board. It consisted in testing the possibility of masitinib to demonstrate superiority over placebo on the primary analysis set in the protocol, based on the EMA guideline on clinical trials in small populations (CHMP/EWP/83561/2005). Alain Moussy, co-founder and CEO, stated "since the data remain blinded to AB Science, the efficacy results will not be known until the study is completed. However, we are very pleased that this pivotal clinical study has passed this important step successfully since the placebo effect was unknown as there has been no previous placebo controlled clinical study carried-out in this orphan disease". About masitinib Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers. Owing to its novel mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. Through its activity of inhibiting certain kinases that are essential in some oncogenic processes, masitinib may have an effect on tumor regression, alone or in combination with chemotherapy. Through its activity on the mast cell and certain kinases essential to the activation of the inflammatory cells and fibrosing tissue remodeling, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases.