Keryx Announces Results of Data Safety Monitoring Committee and Collaborative Study Group (CSG) Review of First Interim Analysis From Phase II/III Clinical Program for KRX-101 (Oral Sulodexide) for the Treatment of Diabetic Nephropathy

Pursuant to this recommendation, and subject to Keryx's successful finalization of its clinical plan with the FDA, Keryx expects to commence its pivotal program, including both Phase III and Phase IV studies for KRX-101, within approximately the next three months. The clinical plan as discussed...

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Bibliographic Details
Published inPR Newswire p. 1
Format Newsletter
LanguageEnglish
Published New York PR Newswire Association LLC 05.01.2005
Subjects
Anticoagulants
Biological products
Clinical trials
Collaboration
Diabetes
Diabetic nephropathy
Drug dosages
FDA approval
Kidney diseases
Patients
New York
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Summary:Pursuant to this recommendation, and subject to Keryx's successful finalization of its clinical plan with the FDA, Keryx expects to commence its pivotal program, including both Phase III and Phase IV studies for KRX-101, within approximately the next three months. The clinical plan as discussed with the FDA for KRX- 101 consists of a single Phase III trial in patients with microalbuminuria to support NDA approval under Subpart H (accelerated approval), based on the surrogate marker of regression of microalbuminuria. The completion of the Phase III is to be followed by the completion of a Phase IV confirmatory study in patients with overt nephropathy (macroalbuminuria) that will measure clinical outcomes. As part of its commitment to the FDA, Keryx plans to commence the Phase IV trial at approximately the same time as the start of the Phase III trial. More than 20 studies have been published assessing the safety and efficacy of KRX-101 in diabetic nephropathy and other vascular conditions. KRX-101 demonstrated significant efficacy in treating patients with diabetic nephropathy in a randomized, double blind, placebo-controlled, 223-patient Phase II clinical trial (the DiNAS Study) conducted in Europe. In this study, Type 1 and Type 2 diabetics with diabetic nephropathy were treated for 4 months with 50-, 100- and 200-milligram per day of KRX-101 and showed dose- dependent reductions in proteinuria. In addition, the data in the DiNAS Study showed that the therapeutic effect of KRX-101 was additive to ACE-inhibitor treatment, suggesting that KRX-101 operates under a different mechanism of action than do ACE inhibitors and ARBs, which represent the existing first line of treatment for the disease. These findings were published in the June 2002 issue of the Journal of American Society of Nephrology. Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx is developing KRX- 101 (sulodexide), a novel first-in-class oral heparinoid compound for the treatment of diabetic nephropathy, which is in a Phase II/ III clinical program. Additionally, Keryx is developing clinical- stage oncology compounds including KRX-0401, a novel, first-in- class, oral AKT inhibitor in Phase II clinical trials. Keryx also has an active in- licensing and acquisition program designed to identify and acquire clinical- stage drug candidates. Keryx Biopharmaceuticals is headquartered in New York City.