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Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
Date:12/5/2007

in/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 Sulonex(TM) versus placebo, with a 1:1 randomization between the two arms. The objective of this Phase 4 study is to determine the efficacy of Sulonex(TM) in reducing the rate of progression to End-stage renal disease and adverse clinical sequelae in patients with type 2 diabetes and macroalbuminuria or overt diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an ARB. All patients 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 patients.

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

ABOUT SULONEX(TM)

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 d
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SOURCE Keryx Biopharmaceuticals
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