Aspreva Pharmaceuticals Corporation, of Victoria, British Columbia, Canada, an emerging pharmaceutical company focused on identifying and developing new drugs and commercializing new indications for approved medications, has announced that patient dosing has begun for the transplant antirejection agent CellCept (mycophenolate mofetil; Roche Pharmaceuticals), for the treatment of lupus nephritis. Aspreva's large multicenter Phase III study is designed to assess the safety and efficacy of the immunosuppressant in inducing and maintaining remission in patients with biopsy-proven lupus nephritis. 

The two-phase induction to maintenance study will randomly assign 328 patients to an open-label comparison of CellCept with the current standard of care, cyclophosphamide, for the first 6 months, followed by a double-blind comparison of CellCept to azathioprine for up to 3 years. Clinical results from the first phase of the study are expected in late 2006, with submission of a regulatory filing expected by late 2007. 

CellCept was first approved in 1995 for use in combination therapy for the prevention of acute organ rejection in kidney transplantation, and has since been approved worldwide for the prevention of organ rejection in adult heart, liver, and kidney transplants. In 2003, Aspreva obtained exclusive worldwide rights (excluding Japan) to develop and market CellCept in autoimmune applications.  Roche will register and invoice such sales and share the proceeds with Aspreva.      

—Nicholas K. Zittell