Alteon of Parsippany, New Jersey, has halted its Phase IIb trial of alagebrium after an independent review board concluded it did not demonstrate sufficient efficacy against uncontrolled systolic hypertension. The company also announced that it had submitted preclinical toxicity data on alagebrium to two divisions of the FDA supporting its view that liver alterations previously observed in rats, which led to a voluntary suspension of enrolling new patients into its clinical trials, were related to the male rat metabolism and not to genotoxic pathways.
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