Aspreva Pharmaceuticals Corporation, of Victoria, British Columbia, announced completion of patient enrollment in a global phase III clinical trial to evaluate mycophenolate mofetil (CellCept®) in combination with corticosteroids in patients with active pemphigus vulgaris (PV), a rare, severe, chronic autoimmune disease that causes blisters of the skin and mucous membranes. The randomized, double-blind, placebo-controlled study will evaluate mycophenolate mofetil in 77 patients with active PV over a treatment period of 52 weeks. The primary end point encompasses both minimal disease activity, defined as no new persistent lesions, and a low steroid dose. The company expects to complete the study in 2007.

Mycophenolate mofetil is an immunosuppressant drug used in combination with other immunosuppressive drugs (eg, cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney, and liver transplants. In October 2003, Aspreva signed a collaboration agreement with F. Hoffmann-La Roche for the exclusive worldwide rights (excluding Japan) to develop and commercialize mycophenolate mofetil for all autoimmune disease applications. Aspreva has initiated two other global phase III clinical trials evaluating mycophenolate mofetil in active lupus nephritis and myasthenia gravis.

— A. Techman