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Alteon pimagedine

Executive Summary

Phase III trial of the AGE formation inhibitor in end-stage renal disease has been discontinued. The company said it may use data from the study to support a definitive trial of the drug if Alteon decides to continue to pursue the indication. Alteon is planning to meet this quarter with FDA regarding the already completed pimagedine Phase III ACTION trial in type 1 diabetics with overt nephropathy or progressive kidney disease. The firm reported in November that the trial's primary endpoint of a 50% reduction in the time to retinopathy failed to reach statistical significance, although there were improvements in secondary endpoints. Alteon expects to receive fast track designation for pimagedine if an NDA is filed

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