DiObex Awarded Patent for the Prevention of Insulin-Induced Hypoglycemia.

DiObex, Inc. (San Francisco, CA), a privately held biotechnology company developing treatments for metabolic diseases, has secured a critical patent from the United States Patent and Trademark Office for the use of very low dose glucagon, or DIO-901, in the prevention of insulin-induced hypoglycemia in diabetes patients. The patent grants DiObex exclusive rights to methods of reducing the risk of hypoglycemia in diabetes patients being treated with insulin by administering very low doses of glucagon.

"This patent protection strengthens our commitment to delivering the first product to the market for the prevention of insulin-induced hypoglycemia in diabetes," CEO David Cory said. "DIO-901 is the only therapeutic in development to prevent insulin-induced hypoglycemia, which is known to limit optimal glycemic control and cause recurring medical complications in most people with type 1 diabetes, in many with type 2 diabetes, and is sometimes fatal."

Insulin-induced hypoglycemia is the limiting factor in the glycemic management of diabetes. Were it not for the barrier of hypoglycemia, people with diabetes might achieve normal HbA1c levels over a lifetime of diabetes. Reduction of mean glycemia over time prevents or delays microvascular complications -- retinopathy, nephropathy, and neuropathy -- in both type 1 and type 2 diabetes. DIO-901 is expected to begin Phase 2 clinical testing later this year and has received Fast Track status from the Food and Drug Administration, underscoring the great unmet medical need in the prevention of insulin-induced hypoglycemia.

DiObex's latest patent, United States Patent 7,314,859, builds on a growing patent portfolio protecting its product candidates for metabolic diseases. In addition to the recently issued United States patent, DiObex owns seven United States patent applications and 30 corresponding foreign patent applications relating to DIO-901. DiObex also owns or has exclusively licensed seven United States patents, five United States patent applications, and more than 100 issued foreign patents and pending foreign and international patent applications relating to DIO-902.

DiObex is a privately held biotechnology company developing novel products for diabetes and metabolic diseases. DiObex has two product candidates in four mid-stage clinical development programs. DIO-901 (very low dose glucagon) is in development for the prevention of insulin-induced hypoglycemia in type 1 diabetes mellitus in an extended release subcutaneous formulation and as a convenient continuous subcutaneous infusion. DIO-901 has received Fast Track status from the FDA. DIO-902 (levdexketoconazole) is an oral, single enantiomer of ketoconazole that is a novel cortisol synthesis inhibitor in development for type 2 diabetes mellitus and diabetic nephropathy. Abnormalities in cortisol activity may play an important role in the development of metabolic syndrome, a constellation of conditions that place people at high risk for type 2 diabetes mellitus and cardiovascular disease.

DiObex, Inc.

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