Regulators halt AB Science's French trials of masitinib

AB Science S.A. (Euronext:AB) said the French National Agency for Medicines and Health Products Safety (ANSM) requested that the company halt ongoing clinical trials of masitinib (AB1010) in France. The decision followed an EMA inspection that found deviations from Good Clinical Practice in the Phase III AB06006 study of masitinib to treat mastocytosis.

The inspection, which ran from 2009 to the beginning of 2015, was part of the marketing authorization that the company is seeking for masitinib in the indication. AB Science said it implemented a new quality system in mid-2015 and noted that 11 site inspections outside of France subsequent to the implementation have yielded no unreported adverse events...