WIXOM, Mich.—Rockwell Medical Technologies, Inc., a manufacturer and developer of concentrates and specialty pharmaceuticals for dialysis patients, reported that patient enrollment has been completed for its ongoing Phase 2b dose-ranging study for its iron deficiency anemia drug soluble ferric pyrophosphate (SFP).
“We are pleased to have achieved this important milestone following two positive safety reviews from the data safety monitoring board (DSMB). We anticipate having study data available in the fourth quarter of 2009 and shortly thereafter commencing our Phase 3 program,” said Robert L. Chioini, chairman, CEO and President of Rockwell Medical.
The Phase 2b dose-ranging study is a six-month, controlled multicenter, double-blind study consisting of approximately 130 hemodialysis patients at multiple dialysis centers in the United States and Canada. Subjects are randomized to receive one of several concentrations of SFP or placebo in dialysate during their normal three times/week dialysis regimen. The primary objectives of the study are to evaluate both safety and efficacy of SFP at varying dose levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range.