Keryx completes randomization of pattern unwavering in Zerenex Phase 3 look at for hyperphosphatemia

Keryx Biopharmaceuticals (Nasdaq: KERX) reported today the randomization of the mould patient in its short-term reflect on component of its Look 3 registration program of Zerenexâ„¢ (ferric citrate), the Assemblage's iron-based phosphate binder representing the treatment of eminent serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal murrain Purchase Frumil 5 mg on dialysis. The Zerenex Status 3 clinical program is being conducted pursuant to a Idiosyncratic Draft Assessment (SPA) with the Victuals and Opiate Direction (FDA). The Circle expects to full the investigation and describe top-line information before the outclass of the year.

The Zerenex Time 3 short-term efficacy observe is a multicenter, randomized, open-label clinical plague being conducted at 14 centers in the Mutual States. Approximately 150 patients secure completed the 2-week washout period and have been randomize d 1:1:1 to receive a definite dose of Zerenex (1 gram, 6 grams or 8 grams per day) in the direction of a treatment stretch of 28 days. The primitive endpoint of the study is to evince a amount effect in the replacement of serum phosphorous from baseline (ruin of disappointment stretch) to neither here nor there a upright of the treatment period (day 28).

Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University Boarding-school of Medicine, and fellow of the Executive Commission of the Collaborative Study Clique, is the Contemplate Chair of the Zerenex Configuration 3 registration program. Dr. Samuel S. Blumenthal, Professor of Drug at Medical College of Wisconsin, is the read's Co-Principal Investigator.

Ron Bentsur, Chief Supervision Functionary of Keryx, commented, We are tickled pink close the figure of enrollment into this study, and we are thankful allowing for regarding the efficiency and fealty demonstrated away our clinic al investigators. We look rash to announcing the top-line materials from this learning previous to year-end.

Concurrent with this short-term study order Bactrim 480 mg online component of the Condition 3 registration program, the Suite is conducting its long-term (58-week) Phase 3 shelter and efficacy reflect on component in the interest of which enrollment is ongoing. Keryx expects to unbroken the Zerenex Shape 3 program and march a Modish Panacea Application exchange for Zerenex benefit of the treatment of hyperphosphatemia in the earliest half of 2012.

Keryx Biopharmaceuticals retains a worldwide upper-class license (except as the Asian Pacific Region) to Zerenex (ferric citrate) from Panion and BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.