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

VICTORIA, BC, Canada and BASEL, Switzerland, June 27 /CNW/ - Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) and Roche today released preliminary results for a clinical trial comparing CellCept (oral mycophenolate mofetil, MMF) to intravenous cyclophosphamide (IVC), which is the current standard of care, for inducing treatment response in the induction phase of patients suffering from lupus nephritis.

Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that MMF was superior to IVC in inducing treatment response in this disease. The results relate to the induction phase of this study, which was designed to measure treatment response in patients after 24 weeks of induction therapy with 185 patients in the MMF arm and 185 in the IVC arm. The results indicate similar treatment responses with 56.2% in the MMF arm and 53% in the IVC arm were observed. Additional analyses are ongoing to determine the potential for a regulatory submission and Aspreva plans to present the final results at an appropriate scientific forum.

Based on preliminary analysis, it appears that, in general, the adverse events experienced by patients in both arms of the study are consistent with those observed in lupus nephritis patients receiving immunosuppressive therapy. Overall incidence of adverse events was comparable in both treatment arms. Aspreva will host a conference call today at 9:30 a.m. ET (6:30 a.m. PT) to discuss these preliminary results.

About Lupus Nephritis

Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints. Lupus nephritis, considered life-threatening, but rare, is the most serious manifestation of SLE. If left untreated, it can lead to kidney failure, need of dialysis, and potentially death. It is a complicated disease as patients typic
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