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Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
Date:2/11/2008

minuria while the subjects are treated with maximum approved or tolerated doses of ACEis or ARBs.

The primary endpoint for the Phase 3 clinical trial is "therapeutic success" at 6 months, where therapeutic success is defined as (i) conversion from microalbuminuria to normoalbuminuria, as measured by albumin/creatinine ratio (ACR), with at least a 25% reduction in ACR relative to baseline ACR, or (ii) a 50% reduction in ACR relative to baseline ACR.

Concurrently with the Phase 3 clinical trial, the Company is continuing enrollment into its Phase 4 clinical trial, which is a randomized, double- blind, placebo-controlled study, also comparing 200 mg daily of sulodexide versus placebo, with a 1:1 randomization between the two arms. The objective of this Phase 4 study is to evaluate the efficacy of sulodexide in reducing the rate of progression to End-stage renal disease and adverse clinical sequelae in subjects with type 2 diabetes and macroalbuminuria or overt diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an ARB. All subjects in the Phase 4 study population are expected to continue to receive maximum approved or tolerated doses of ARBs during the course of the study. The Phase 4 study is designed to enroll approximately 2,200 subjects.

The Company has committed to the FDA, as a condition to the accelerated approval of sulodexide based on the Phase 3 clinical trial, that the Phase 4 study would be substantially enrolled at the time of the filing of the NDA for sulodexide.

ABOUT SULONEX (sulodexide oral gelcap)

Sulodexide 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 hepa
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SOURCE Keryx Biopharmaceuticals
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