The Philadelphia-based Exocell, Inc. has recently signed an agreement with Eurand International for the clinical development of an orally administered compound that could help prevent diabetic kidney disease. The compound, EXO-226, will be produced and supplied by Eurand for use in the first phase of clinical trials for FDA approval. Exocell anticipates that these trials will begin in early 1997.
EXO-226 would prevent kidney damage by lowering the levels of glycated albumin in the blood stream. Albumin is a simple protein that is found in many varieties in the tissues and fluids of plants and animals. As R.S. Clements, MD, of Exocell explained to DIABETES HEALTH, the excess sugar in the blood of a person with diabetes binds to this protein and in turn this glycated albumin damages kidney cells and leads to the development of diabetic kidney disease, or nephropathy. EXO-226 works by keeping albumin from becoming glycated. In animal experiments Exocell has been successful in showing that lowering the levels of glycated albumin prevents kidney damage in diabetes.
In the United States, diabetic nephropathy is the cause of 35 percent of the cases of end stage kidney disease and is the largest cause of kidney failure that results in dialysis or transplantation.
Despite the fact that clinical trials have yet to be started, President and Chief Scientific Officer at Exocell, Dr. Margo P. Cohen, comments, “Our agreement with Eurand assures the rapid development of EXO-226 into a product that will protect people with diabetes from one of the most feared complications of the disease.”
While Dr. Cohen concedes that the risk of kidney disease can be lowered by normalizing blood glucose levels, she points out that this degree of control is unachievable in most cases of diabetes. With EXO-226, Exocell is attempting to avoid the problem by directly addressing a causal link between high blood sugars and kidney disease.