BioStratum's drug Pyridorin™ enters human clinical trials for treatment of diabetic kidney disease

Research Triangle Park, N.C. - September 8, 1999 - BioStratum Incorporated today announced the initiation of human clinical trials of its drug candidate Pyridorin™ for the treatment of diabetic kidney disease. Oral administration
of Pyridorin in human subjects (Phase I) will begin this week. Pyridorin has demonstrated efficacy and safety in preclinical studies.

Diabetic kidney disease is an enormous medical problem. In the U.S. approximately 30 to 40 percent of patients with type 1 diabetes and 10 to 15 percent of patients with type
2 diabetes (a total of 1.5 million patients) develop diabetic kidney disease, the leading cause of end-stage renal failure. It is estimated that kidney related complications
in diabetes cost the U.S. healthcare system over $5
billion annually.

Pyridorin is a potent inhibitor of glucose-related
biochemical processes that are accelerated in diabetes. More specifically, Pyridorin inhibits non-enzymatic glycoxidation chemical reactions that modify proteins
and other biomolecules and lead to the formation of
so-called advanced glycation end-products (AGEs).
AGE formation in tissues is considered part of the normal aging process. However, in diabetes, AGE formation is accelerated due to high blood glucose and oxidative stress, and is regarded as a major contributing factor in diabetic kidney disease.

In preclinical studies, Pyridorin inhibited AGE formation in tissues and the progression of kidney disease in animal models of diabetes. Pyridorin also lowered serum cholesterol and triglyceride levels. "Pyridorin has looked good from the very beginning, and our recently obtained pre-clinical toxicity profile is very encouraging," said
Archie Prestayko, Ph.D., BioStratum's President and CEO.

"Pyridorin's effectiveness may be related to its specific mechanism of action," added Dr. Prestayko. "Pyridorin exhibits activity against the post-Amadori reaction intermediate, a specific pathway of AGE formation. We believe this pathway of AGE formation is particularly relevant in diabetic kidney disease, and could account
for Pyridorin's improved performance over aminoguanidine
in preclinical studies."

BioStratum Incorporated is a privately held company developing proprietary therapeutics based on recent scientific advances in basal lamina and related technologies. The company's drug candidates are directed against novel basal lamina extracellular targets involved in degenerative and invasive disease processes fundamental to kidney disease, diabetes and cancer. The company has also developed methods for the production of recombinant basal lamina proteins for use in wound repair and tissue regeneration.