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news.The FDA is supporting Accentia Biopharmaceuticals' submission of an investigational new drug application for a Phase III trial of Revimmune, for refractory, relapsing-remitting multiple sclerosis.
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The Revimmune multiple sclerosis (MS) study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that the study will be conducted under a special protocol assessment (SPA).
Accentia will proceed with submission of the investigational new drug (IND) application under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase III study in the first half of 2008.
Developed by Dr Richard Jones, Dr Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow.