Alteon Inc. announced that the FDA has approved a finalprotocol for pivotal multicenter Phase II/III clinical trials ofaminoguanidine in diabetic nephropathy.
The FDA in April asked Alteon (NASDAQ:ALTN) to expand theprotocol to include a second treatment arm at an additionaldose.
Alteon's corporate partner in the clinical development ofaminoguanidine is Marion Merrell Dow Inc. (NYSE:MKC), withwhich Alteon formed an alliance in December 1990 to developand commercialize therapeutics for treating the complicationsof diabetes and aging.
Alteon's aminoguanidine is designed to inhibit the damage tocells, tissues and organs caused by protein cross-linkingadvanced glycosylation end-products (AGEs) formed as a resultof glucose in the body's circulatory system. Although theformation of AGEs and cross-linking are natural consequencesof aging, they occur at an accelerated rate in diabetic patients.
Researchers from Alteon of Northvale, N.J., and theircollaborators presented data from various in vitro -- Jennifer Van Brunt Senior Editor (c) 1997 American Health Consultants. All rights reserved.