Alteon research collaborator receives funding for diabetic complications study
|
|
Alteon, Inc., (ALT) announced that one of its collaborators, Mark Cooper, MD, PhD, professor, the Baker Heart Research Institute, Melbourne, Australia, has been awarded a grant from the Juvenile Diabetes Research Foundation (JDRF) to help fund a multinational phase II clinical study of the effect of Alteon’s lead compound alagebrium on renal function in patients with type 1 diabetes and microalbuminuria.
An A.G.E. Crosslink Breaker, alagebrium will be tested for its ability to reverse kidney damage caused by diabetes, and to reverse the protein excretion which is characteristic of diabetic nephropathy.
Diabetes is the leading cause of kidney failure in the United States. When blood sugar increases, as it does in diabetes, it non-enzymatically modifies proteins to form chemical structures known as advanced glycation end-products (A.G.E.s), leading to a loss of flexibility and function in tissues and organs throughout the body, including the kidney. Alagebrium chloride is the first in a new class of compounds developed by Alteon to break the A.G.E. crosslinks, and may therefore be a promising new treatment to prevent the kidney failure caused by diabetes. Cooper has performed many preclinical studies that appear to validate the use of alagebrium in diabetic nephropathy.
“In preclinical studies, we have shown that renal damage in diabetes is partly caused by sugar-protein complexes called Advanced Glycation End-products (A.G.E.s), and that treatment with alagebrium, an A.G.E. Crosslink Breaker, can improve renal function and structure,” said Cooper. “We are grateful to the JDRF for this grant that will enable us to explore these exciting findings in diabetic patients.”
A phase II protocol for the clinical study has been developed. The randomized, double-blind, placebo-controlled study will test alagebrium in 80 patients with type 1 diabetes between the ages of 18-65 who are in the early stages of kidney disease. There will be an 8-week single-blind, run-in period during which placebo and an ACE inhibitor, standard background therapy for this patient population, will be administered to all patients.
This will be followed by 24 weeks of double-blind treatment with either placebo or alagebrium in combination with an ACE inhibitor. Changes in albumin excretion rate will be the primary endpoint of the study. The study, which is expected to be initiated in the fourth quarter of 2006, will be conducted at three sites in Australia and one in Denmark. Notable nephrologist Hans-Henrik Parving, MD, professor of Medicine, Chief Physician, Steno Diabetes Center, Gentofte, Denmark, and Faculty of Health Science, University of Aarhus, Denmark, will serve as the investigator in Denmark.
“We are delighted that we will be working with Drs. Cooper and Parving on this phase II evaluation of alagebrium in diabetic kidney disease, a medical condition in great need of new therapies,” said Kenneth I. Moch, president and CEO of Alteon. “This study complements our ongoing phase II efforts in diastolic heart failure, another disease that can be a complication of diabetes.”
“Based on the preclinical studies performed by Cooper using alagebrium, we are encouraged that this clinical trial may demonstrate clinical utility in type I diabetics,” said Parving. “I look forward to participating in this multinational study.”
Print Version
Tell-a-Friend comments powered by Disqus
