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Aspreva and Roche Announce Preliminary Results for Phase III Study,Evaluating CellCept in Lupus Nephritis

ally fluctuate between periods of intense disease activity, during which the patient's own immune system is actively attacking and causing damage in their kidney, and periods of remission. Aspreva estimates that there are about 600,000 diagnosed lupus nephritis patients worldwide. There have been no new approved treatment options for SLE or lupus nephritis in the United States in over forty years. Current induction treatments involve the off-label use of existing cancer drugs such as cyclophosphamide, steroids, and immunosuppressants such as azathioprine. These treatments can also have life-threatening side effects that can be worse than the disease itself. Since the disease is more prevalent in women and tends to manifest itself when they are of child-bearing age, drugs that adversely affect fertility can also compound the negative impact of the disease on a patient's quality of life.

More About the Aspreva Lupus Nephritis Study

Aspreva's lupus nephritis study is one of the largest phase III studies ever conducted in lupus nephritis. This two-phase induction to maintenance study was designed as a randomized open label comparison of mycophenolate mofetil (MMF) with cyclophosphamide for the first six months (induction phase), followed by a double-blind comparison of MMF to azathioprine for up to three years (maintenance phase). Treatment response in the induction phase of this trial was defined as a decrease in proteinuria and the stabilization or improvement of serum creatinine. The first patient of this study was treated in July 2005 and patient enrollment was completed at the end of September, 2006. Re-randomization to the maintenance phase is complete and this phase of the study is ongoing. It is important to note that MMF is not currently approved by the FDA for the treatment of any autoimmune disease.

Conference Call

Aspreva will host a conference call to discuss results on Wednesday, June 27, 2007 at 9:30 a.m. ET (6:30 a.m. PT).


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