Preliminary results for phase III study evaluating CellCept in lupus nephritis
Aspreva Pharmaceuticals Corporation and Roche today released preliminary results for a clinical phase III 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 were observed, with 56.2% in the MMF arm and 53% in the IVC arm. Additional analyses are ongoing to determine the potential for regulatory submission, and Aspreva plans to present the final results at an appropriate scientific forum in the future.
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.
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