вторник, 26 октября 2010 г.
Keryx completes randomization of form serene in Zerenex Work in 3 look championing hyperphosphatemia
Keryx Biopharmaceuticals (Nasdaq: KERX) reported today the randomization of the model invalid in its short-term turn over component of its Moment 3 registration program of Zerenex⢠(ferric citrate), the Assemblage's iron-based phosphate binder representing the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal murrain buy Frumil 5 mg on dialysis. The Zerenex Status 3 clinical program is being conducted pursuant to a Gala Etiquette Assessment (SPA) with the Bread and Opiate Supervision (FDA). The Company expects to complete the consider and report top-line data in advance of the outclass of the year.
The Zerenex Period 3 short-term efficacy inquiry is a multicenter, randomized, open-label clinical hard times being conducted at 14 centers in the United States. Nearly 150 patients deliver completed the 2-week damp squib stretch and have been randomized 1:1:1 to receive a fixed dose of Zerenex (1 gram, 6 grams or 8 grams per era) in the direction of a treatment full stop of 28 days. The primary endpoint of the review is to protest a dispense response in the mutate of serum phosphorous from baseline (outstrip of flop stretch) to goal of the treatment interval (daytime 28).
Dr. Julia Lewis, Professor of Drug, Department of Nephrology, Vanderbilt University Primary of Remedy, and colleague of the Chief executive officer Commission of the Collaborative Study Gang, is the Contemplate Throne of the Zerenex Phase 3 registration program. Dr. Samuel S. Blumenthal, Professor of Drug at Medical College of Wisconsin, is the bookwork's Co-Principal Investigator.
Ron Bentsur, Chief Supervision Functionary of Keryx, commented, We are tickled pink by the tariff of enrollment into this mull over, and we are grateful for the expertness and dedication demonstrated by our clinical investigators. We look forward to announcing the to p-line data from this exploration earlier year-end.
Concurrent with this short-term study buy Bactrim 480 mg online component of the Phase 3 registration program, the Performers is conducting its long-term (58-week) Phase 3 safe keeping and efficacy study component for which enrollment is ongoing. Keryx expects to full the Zerenex Phase 3 program and case a Latest Panacea Application to Zerenex benefit of the treatment of hyperphosphatemia in the first half of 2012.
Keryx Biopharmaceuticals retains a worldwide upper-class document (except seeking the Asian Pacific Region) to Zerenex (ferric citrate) from Panion and BF Biotech, Inc. The Comrades has sublicensed the incident of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
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