NEW YORK, April 15 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today reported updated long-term efficacy and safety data on Zerenex(TM) (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) from an open-label extension study in patients with end-stage renal disease (ESRD) who are on dialysis. This data was presented yesterday at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place in Orlando, Florida in a poster entitled "Long-Term Use of Ferric Citrate in End-Stage Renal Disease Patients."
The therapeutic goal of the study was to achieve and maintain a serum phosphorus level below 5.5 mg/dL. The mean levels of serum phosphorus (SP) and phosphorus x calcium product (PxC) for the evaluable patients at each time point over the treatment period were as follows:
Iron parameters were measured at baseline and then quarterly through month 9. On average, slight increases were observed over time, across all key parameters, as follows:
There were 8 patients that had IV iron supplements withheld for approximately 3 to 6 months and there were 8 patients that had EPO withheld for approximately 1 to 10 months during the OLE trial. Out of the 16 patients in the two groups, three patients had both IV iron and EPO withheld.
The investigators concluded that in this OLE trial of ferric citrate with doses as high as 6 g/day, ferric citrate demonstrated the potential to be used long-term as a phosphate binder in ESRD patients. Ferric citrate appeared to be efficacious in controlling serum phosphorus and well-tolerated and safe for up to one year. Additionally, it is the investigators' opinion that this OLE trial, along with data from both animal studies and the Phase 2 high dose trial supports the notion that some iron absorption may be occurring with the use of ferric citrate as a phosphate binder in ESRD patients and that if a reduction in the use of IV-iron supplements and/or EPO are documented in future long-term clinical trials, the cost-benefit and cost-effectiveness of ferric citrate as a phosphate binder, as compared to currently marketed phosphate binders, would be significant.
The Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
About Keryx Biopharmaceuticals, Inc.
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CONTACT: Lauren Fischer, Director - Investor Relations, Keryx
Biopharmaceuticals, Inc., +1-212-531-5965, lfischer@keryx.com
Web site: http://www.keryx.com/
