Alteon Inc. has been notified by the US Food & Drug Administration's (FDA) Reproductive and Urologic Drug Products Division that it is maintaining the clinical hold previously placed on the Company's Phase 2a study of alagebrium in diabetic patients with erectile dysfunction.

In June, the Company announced that it had submitted preclinical toxicity data on alagebrium to two divisions of the FDA's Center for Drug Evaluation and Research (CDER), specifically the Division of Cardio-Renal Drug Products and the Division of Reproductive and Urologic Drug Products.

Following the review of the rat liver data, CDER's Division of Reproductive and Urologic Drug Products placed on clinical hold further enrollment in the Emerald study, the Company's Phase 2a study of alagebrium in diabetic patients with erectile dysfunction, and it requested further preclinical toxicity data, which the Company submitted in August. Now that the Division has reviewed these data, it has decided to maintain the clinical hold pending further preclinical testing.

Alteon is developing new classes of drugs that have shown the potential to reverse or slow down diseases of aging and complications of diabetes.