NEW YORK, June 22, 2007 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that abstracts related to Sulonex(TM) (sulodexide oral gelcap) have been selected for publication or presentation during the poster sessions scheduled to take place at the upcoming American Diabetes Association (ADA) 67th Annual Scientific Sessions and exposition at the McCormick Place Lakeside Center in Chicago, Illinois.
Copies of these abstracts, which highlight the mechanism of action of Sulonex(TM) as well as observed clinical activity, are currently available and can be viewed on-line through the ADA website: http://scientificsessions.diabetes.org/index.cfm?fuseaction=Locator.DisplaySea rchAbstract&CalledByID=1006
Abstracts selected for poster presentation include the following: Saturday, June 23, 2007 (12:30pm-2:30pm): 0733 - Role of Reactive Oxygen Species in High Glucose-Induced Heparanase Expression and Heparan Sulfate Proteoglycan Degradation in the Human Endothelial Cells XIULONG XU, GEETHA RAO, WENDY HUANG, RICHARD A. PRINZ, EDMUND J. LEWIS, Chicago, IL Sunday, June 24, 2007 (6:15pm-7:30pm): 0573 - Treatment of Diabetic Nephropathy with Sulodexide: Final Phase II Safety and Efficacy Results EDMUND J. LEWIS, JULIA LEWIS, SAMUEL S. BLUMENTHAL, THOMAS WIEGMANN, LAWRENCE HUNISCKER, ITAMAR RAZ, Chicago, IL, Nashville, TN, Milwaukee, WI, Kansas City, KS, Iowa City, IA, Jerusalem, Israel 0769 - Mechanism and Relevance of Reduced Presence of Glomerular Heparan Sulfate for Proteinuria in Overt Diabetic Nephropathy TESSA WIJNHOVEN, MABEL VAN DEN HOVEN, TOIN H. VAN KUPPEVELT, JOHAN VAN DER VLAG, JO H. BERDEN, RICHARD A. PRINZ, EDMUND J. LEWIS, MELVIN SCHWARTZ, XIULONG XU, Nijmegen, Netherlands Antilles, Chicago, IL Additional abstracts of inte rest include: 2220 - Oral Administration of Sulodexide for the Treatment of Diabetic Nephropathy in a Phase II Study has Minimal to No Effect on Coagulation or Fibrinolytic Activity JULIA LEWIS, ITAMAR RAZ, SHERWYN SCHWARTZ, STEPHEN ARONOFF, MURRAY KATZ, GILBERT EISNER, JAMES MERSEY, Nashville, TN, Jerusalem, Israel, San Antonio, TX, Dallas, TX, Tucson, AZ, Washington, DC, Baltimore, MD 2376 - Efficacy and Safety of Sulodexide in the Treatment of Diabetic Nephropathy RAM WEISS, ROBERT M. NIECESTRO, ITAMAR RAZ, Jerusalem, Israel, New York, NY
Sulonex (sulodexide oral gelcap) belongs to a proposed new class of nephroprotective, or kidney protecting, drugs, known as the glycosaminoglycans. A variety of members of this chemical family have been shown to decrease pathological albumin excretion in diabetic nephropathy in humans. Some of the members of this chemical family include the following approved drugs: standard heparin, low molecular weight heparin and danaparoid. These agents all require therapy by injection and are all potent anticoagulants, which are blood thinners capable of inducing bleeding. Sulonex, on the other hand, is given orally and, in this form, has demonstrated little, if any, anticoagulant effects to date.
Keryx owns the exclusive rights to use Sulonex(TM) for the treatment of diabetic nephropathy in North America, Japan and certain other markets outside of Europe. Diabetic nephropathy is a long-term complication of diabetes in which the kidneys are progressively damaged. Sulonex is a glycosaminoglycan compound with structural similarities to the broad family of marketed heparins and low molecular weight heparins. This drug has been marketed in a number of European, Asian and South American countries for many years by our licensor for certain cardiovascular conditions and has an established safety profile at the doses used for such indications. Additionally, it has been demonstrated in multiple clinical trials conducted in Europe and the U.S., including two randomized, double-blind, placebo-controlled Phase II studies, that Sulonex can reduce urinary protein excretion in patients with diabetic nephropathy. Sulonex is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment, or SPA, with the Food & Drug Administration, or FDA. These trials are being conducted by the Collaborative Study Group, or the CSG, the world's largest standing renal clinical trials group.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is Sulonex(TM) (sulodexide oral gelcap), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex 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 Zerenex(TM), an oral, inorganic, iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase II clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end- stage renal disease. Keryx is also 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 id entify and acquire additional drug candidates. Keryx is headquartered in New York City.
KERYX CONTACT: Ronald C. Renaud Jr. Chief Financial Officer, Treasurer Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965
CONTACT: Ronald C. Renaud Jr., Chief Financial Officer, Treasurer of KeryxBiopharmaceuticals, Inc., +1-212-531-5965
Ticker Symbol: (NASDAQ-NMS:KERX)
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