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For Immediate Release Keryx Biopharmaceuticals Provides Update on KRX-101 Clinical Development Program --FDA Clears Company to Proceed to Phase III Trial Design-- BOSTON and JERUSALEM, September 27, 2000 - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; AIM: KRX) today provided an update on the clinical development of its drug compound, KRX-101 (sulodexide), for the treatment of diabetic nephropathy. After recently meeting with the U.S. Food and Drug Administration (FDA) as part of an ongoing dialogue regarding the clinical pathway of the product, the Company announced that it has approval to proceed to Phase III clinical trials of KRX-101 in the United States. Keryx will next design a study protocol for submission to the FDA. "We recognize and appreciate the FDA's direction and effort in helping us to define the U.S. clinical development pathway for KRX-101," said Morris Laster, M.D., Chairman and Chief Executive Officer of Keryx Biopharmaceuticals. "Diabetic nephropathy is a tragic condition for millions of people. Eventually, we hope to be able to mitigate this life-threatening medical condition that afflicts such a substantial percentage of diabetic patients worldwide." Keryx in-licensed KRX-101 from Alfa Wassermann for the treatment of diabetic nephropathy. Sulodexide has been shown to have a strong safety profile based on nearly 20 years of commercial use as a cardiovascular therapeutic in Europe, Asia and South America and past clinical trials in nearly 3,000 patients. Nephropathy, one of the most common complications of diabetes, results in the degradation of kidney function. This condition generally progresses to the point that the patient must undergo regular dialysis or obtain a kidney transplant to survive. The goal of treatment, therefore, is to slow the progression of kidney damage and control related complications. In addition to developing KRX-101, Keryx's principal efforts are directed to the discovery of drugs that target kinases using its proprietary KinAceä platform. This post-genomics, core technology enables the Company to generate new drug candidates for a variety of conditions, such as cancer and metabolic, cardiovascular, immunological, and neurological disorders. About Keryx Biopharmaceuticals Statements contained or referenced in this news release that are not historical facts may be forward-looking statements, as the term is defined in the Private Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "anticipate", "estimate", "expect", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Our actual results and the timing of certain events may differ significantly from the results discussed in forward-looking statements. Factors that might cause or contribute to such a discrepancy include, but are not limited to, the risks outlined in our Registration Statement on Form S-1 filed with the Securities and Exchange Commission. The forward-looking statements contained in this filing or in our Registration Statement on Form S-1 include, among other things, statements relating to our drug development and regulatory strategy, growth strategy, use of proceeds, projected capital expenditures, research and development expenditures, other costs and expenses, revenue, profitability, and liquidity and capital resources.
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