NEW YORK, Oct. 24 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that Edmund J. Lewis, MD, of the Collaborative Study Group, will be presenting final data from the Company's Phase II study of KRX-101 (oral sulodexide gelcap) for diabetic nephropathy at the American Society of Nephrology's (ASN) Renal Week in Philadelphia, PA (November 8-13, 2005). Dr. Lewis' presentation, entitled "Interim Analysis of a Pilot Trial of Sulodexide in Type 2 Diabetic Nephropathy with Microalbuminuria," is scheduled to begin at approximately 5:40pm EST on Friday, November 11th, 2005 as part of a session entitled "Novel Clinical Markers and Therapy in Diabetes." Dr. Lewis was granted an oral presentation based on the interim data that was available at the time of abstract submissions. Dr. Lewis will be discussing the full phase II data in this oral presentation.
KRX-101, the Company's lead compound for the treatment of diabetic nephropathy, is currently in a global pivotal Phase 3 and Phase 4 clinical program. Dr. Edmund J. Lewis is the Principal Investigator of this clinical program and served as a Principal Investigator in the Phase II study.
This presentation will not be webcast.
In addition to Dr. Lewis' oral presentation, several other abstracts related to KRX-101 (sulodexide) will be featured during the ASN Renal Week poster sessions. These abstracts include the following:
* #PO331 Increased Heparanase-1 Expression in the Kidneys of Patients with Diabetic Nephropathy. * #PO534 Mechanism of Action of Sulodexide-Mediated Control of Diabetic Proteinuria: Inhibition of Heparanase-1 Activity. * #PO443 Sulodexide Reduces Renal Injury in Experimental Radiation Nephropathy. * #PO369 Documentation of Low Levels of Urine Albumin Excretion in Type 2 Diabetic Nephropathy. ABOUT THE COLLABORATIVE STUDY GROUP
The Collaborative Study Group (CSG), the largest standing renal clinical trials group worldwide, is comprised of academic and tertiary care physician- researchers interested in collaborative clinical trials investigating new therapeutic approaches in the treatment of kidney disease. Since 1979, the CSG has conducted multiple large-scale clinical trials resulting in over 40 major publications in peer-reviewed journals. The CSG conducted pivotal trials of ACE Inhibition in Type 1 Diabetic Nephropathy and of Irbesartan in Type 2 Diabetic Nephropathy (I.D.N.T.), both of which led to FDA product registration for new indications and the recommendation of these agents as standard of care by the American Diabetes Association. The results of each of the CSG's last three major clinical trials were published in the New England Journal of Medicine. The IDNT multi-national trial in collaboration with Bristol-Myers Squibb and Sanofi-Synthelabo is the largest trial in renal disease to date, consisting of 1,715 patients from 210 investigative sites worldwide. The CSG is currently conducting the pivotal clinical program for KRX-101, including both the Phase III and Phase IV studies.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is KRX-101 (sulodexide), a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life- threatening kidney disease caused by diabetes. KRX-101 is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing clinical-stage oncology compounds, including KRX-0401, a novel, first-in-class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. KRX-0401 is currently in Phase II clinical development for multiple tumor types. Keryx also has an active in- licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Contact: Keryx Biopharmaceuticals, Inc. Ron Bentsur, Vice President, Finance & Investor Relations (212) 531-5965 ron@keryx.com
Keryx Biopharmaceuticals, Inc.CONTACT: Ron Bentsur, Vice President, Finance & Investor Relations, KeryxBiopharmaceuticals, Inc., +1-212-531-5965, ron@keryx.com
Web site: http://www.keryx.com/
