Keryx Biopharmaceuticals Announces Completion Of Patient Randomization Into Sulonex Phase III Pivotal Study Part 2

The Company have committed to the FDA, by means of the use of a stipulation to the commendation of Sulonex stand within opposition the Phase 3 clinical tribulation below the guidelines of get going approval, that the Phase 4 be trained would be substantially enrol at the juncture of the file of the NDA in support of Sulonex. The Company believe they be on track to harvest round their commitment beside in the sector of 40% of the sought after patients already randomized.

"We are strongly inflamed to delight in achieve this decisive milestone in the initiation of Sulonex(TM) and we are indebted for the tremendous dedication, endow with your support to and guidance of the Collaborative Study Group and all the CSG investigators entire who steadfast themselves to completing this study in a timely-fashion for the wished-for plus of their patients," stated Michael S. Weiss, Chairman & CEO of Keryx. Weiss added, "We keenly await the proceed of this worldwide Phase 3 clinical trial." Edmund J. Lewis, MD, mention, "This be the largest trial ever conduct in patients with microalbuminuria and we are enthralled that the Collaborative Study Group could once again organize the development of a resourceful agent for this vomiting. Randomizing this constant patients here timeframe is testament to the dedication and point of our CSG investigators. All of us at the CSG are encouraged in the region of the prospects of Sulonex and are hopeful to have this untried medication reachable to luxury our patients." The Sulonex step 3 and Phase 4 program is everybody conducted by The Collaborative Study Group (CSG), the world's largest on two legs renal clinical trial article, whose lynching of the angiotensin-converting enzyme (ACE) inhibition trial of captopril in Type 1 diabetic nephropathy and the angiotensin II receptor blocker (ARB) trial of irbesartan in Type 2 diabetic nephropathy (I.D.N.T. study) both lead to FDA approval and the guidance of these agents as standards of carefulness by the American Diabetes Association.

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