Wednesday, June 17, 2015
The FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug designation to Protalex’s PRTX-100 for the treatment of immune thrombocytopenia (ITP). PRTX-100, Protalex’s lead product, is a highly purified form of Staphylococcal Protein A. The FDA previously accepted the company’s IND application for a phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Protalex expects to enroll its first patient in an ITP study in the third quarter of 2015.