Aspreva Pharmaceuticals Corporation of Victoria, British Columbia, Canada, has announced the results of an investigator-initiated trial comparing orally administered mycophenolate mofetil (CellCept®; F. Hoffmann-La Roche) to intravenous cyclophosphamide as induction therapy for active lupus nephritis.

Published in the November 24, 2005, issue of the New England Journal of Medicine,¹ the 24-week, randomized, open-label, multicenter, noninferiority study of 140 patients with systemic lupus erythematosus who had advanced stages of lupus nephritis demonstrated that induction therapy with mycophenolate mofetil was superior to intravenous cyclophosphamide in inducing complete remission of lupus nephritis and was also better tolerated with fewer severe side effects.

CellCept is an immunosuppressant drug used in combination with other immunosuppressive agents (cyclosporine and corticosteroids) to prevent rejection in patients receiving heart, kidney, and liver transplants. 

Based on this investigator-initiated trial and acceptance of the study protocol by regulatory authorities, the company initiated its global Phase III Aspreva Lupus Management Study (ALMS). The first patient in this trial was treated in July 2005, and completion of the induction phase of the study is expected by the end of 2006.

Aspreva also announced enrollment completion for a 36-week, randomized, double-blind, placebo-controlled global phase III study of mycophenolate mofetil in patients with myasthenia gravis, a chronic autoimmune neuromuscular disease. The 176-patient trial, expected to be completed by the end of 2006, is evaluating the potential of mycophenolate mofetil to maintain or improve symptom control with reduced corticosteroids. 

Aspreva, an emerging pharmaceutical company focused on identifying, developing, and commercializing new indications for approved drugs and medications in late-stage development for less common diseases, signed a collaborative agreement with Roche Pharmaceuticals in October 2003 for the exclusive worldwide rights (excluding Japan) to develop and commercialize CellCept for all autoimmune diseases.  
 
—A. Techman

Reference

1. Ginzler EM, Dooley MA, Aranow C, et al. Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. N Engl J Med. 2005;353:2219-2228.