Keryx Biopharmaceuticals Inc announced that the United States Patent and Trademark Office have granted Patent No. 6,080,732 for the use of KRX-101 (sulodexide) in the treatment of diabetic retinopathy, an eye-related complication of diabetes. The Company has exclusive U.S. rights to the patent under its licensing agreement with Alfa Wassermann, S.p.A. Issuance of this patent compliments the late-stage clinical development program Keryx has in place with KRX-101 for the indication of diabetic nephropathy, a kidney-related complication of the disease.
In addition to their work with KRX-101, the Company continues to advance its KinAce platform, a broad, post-genomics technology for the discovery of kinase-targeted drugs.
"Our current focus is on the advancement of the clinical program for KRX- 101 in diabetic nephropathy," said Morris Laster, chairman and chief executive officer, Keryx Biopharmaceuticals Inc. "However, we believe that KRX-101 has long-term potential for other diseases and this patent provides a foundation on which to expand the compound's future clinical development.
In September, Keryx received U.S. Food and Drug Administration (FDA) approval to submit a protocol for a Phase III trial with KRX-101 for the indication of diabetic nephropathy, for which current therapy is inadequate. The Company is actively designing a protocol for this Phase III trial.
Retinopathy affects approximately 85 percent of those suffering from diabetes in the Western world. This condition is characterized by lesions on the retina, as well as damage to the blood vessels that are responsible for supplying the retina with blood, and may lead to distorted vision, or even blindness. Preliminary clinical observations have shown that patients with diabetic retinopathy who are treated with sulodexide demonstrate improvement of retinic lesions.