Protalex Inc. announced that the French National Agency for Medicines and Health Products (ANSM) has approved the company's clinical trial application to begin a Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP). This approval authorizes Protalex to initiate the study (PRTX-100-203 Study) at several sites in France. The company expects to commence enrollment before year end.

In addition, Protalex announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending PRTX-100 for designation as an orphan medicinal product for the treatment of ITP. Approval of the 203 Study and the positive COMP opinion follow Protalex's previously announced initiation of a U.S. Phase I/II clinical trial of PRTX-100 in adult ITP patients (PRTX-100-202 Study) and receipt of Orphan Drug Designation (ODD) for PRTX-100 to treat ITP from the U.S. Food and Drug Administration's Office of Orphan Products Development.