Alteon has been advised that it should discontinue its Phase III trialof pimagedine in non-insulin-dependent (type II) diabetes patients with overt nephropathy, after the trial's external safety monitoring committee found an increased risk of side effects in the treatment group.
Alteon is reviewing the future of the ACTION II study with the US Food and Drug Administration and commercial partner Genentech. Pimagedine prevents the formation of advanced glycated end-products and AGE-induced protein crosslinking, which have been linked to the complications of diabetes.
IDDM, ESRD Studies Continue The ESMC recommended continuation of the ACTION I study in insulin-dependent (type I) diabetes with overt nephropathy, which is scheduled for completion and data-release before the end of the year. Pimagedine is also in a Phase III study in end-stage renal disease; the monitoring committee for this trial recommended that it should continue at its last review meeting on March 12.
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