Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ran...( WIXOM Mich. Sept. 19 /- Rockwell ...),Health

WIXOM, Mich., Sept. 19 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), announced today that it has commenced enrollment in its Phase IIb dose-ranging study for Soluble Ferric Pyrophosphate (SFP), a physiological iron-maintenance therapy drug.

The Phase IIb dose-ranging study is a nine-month, controlled multi-center, double-blind study consisting of up to 130 patients at multiple dialysis centers in the United States. Patients will receive SFP during their normal three times/week dialysis regimen. The primary objectives of this study are to evaluate both safety and efficacy of SFP at varying dosage levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range, in patients undergoing hemodialysis. Secondary endpoints include evaluating efficacy for changes in hemoglobin levels over time, reticulocyte hemoglobin content, incidence of systemic infection episodes and to quantify the amount of SFP iron transferred from the dialysate directly to the blood during the dialysis session. Results of this Phase IIb study are expected by the end of 2008.

Robert L. Chioini, Chairman and CEO of Rockwell stated, "We are excited to initiate this important step in our clinical development plan for SFP, a key product in Rockwell's renal drug development pipeline. The completion of this study will enable us to initiate our planned Phase III pivotal study program for FDA market approval of SFP. Mr. Chioini also stated, "We have assembled a team of top-tier investigators who will be conducti
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