Revimmune cyclophosphamide regulatory update

FDA granted Orphan Drug designation for Accentia's Revimmune cyclophosphamide to prevent graft-versus-host disease (GvHD) following bone marrow transplant. The ultra-high intensity, short-course of an IV formulation of cyclophosphamide is in Phase I/II testing for the indication and has Orphan Drug designation to treat systemic sclerosis and autoimmune hemolytic anemia. The company plans to begin a Phase III trial of Revimmune to treat multiple sclerosis (MS) in early 2012. ...