Accentia agrees with FDA on Revimmune trial

Florida, USA-based Accentia Biopharmaceuticals says that it met with the Food and Drug Administration for a scheduled pre-Investigational New Drug review of Revimmune, an intravenous form of cyclophosamide. The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase III randomized controlled, multicenter clinical trial of the product, the company's potential therapeutic for refractory, relapsing-remitting multiple sclerosis. The agency indicated that it supports the proposed submission from Accentia and is in overall agreement with the proposed design of the Accentia clinical program.

The Revimmune MS study will enroll subjects in a one-year trial comparing baseline disability to that 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 this unique study will be done under a special protocol assessment. Accentia will proceed with submission of the IND under a SPA and of an for Fast Track status, and currently projects commencement of the Phase III study in the first half of 2008.

Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity.