Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron-deficiency anemia, announced today the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.
With guidance given from the U.S. Food and Drug Administration (FDA), Rockwell Medical has established that the primary efficacy analysis for the two Phase III efficacy studies will be the comparison of the mean change in hemoglobin from baseline between the SFP group and the placebo group. Branded as the CRUISE (Continuous Replacement Using Iron Soluble Equivalents) study, each of the Phase III efficacy studies will have two treatment groups: one receiving an 11 mcg/dL dose of SFP-iron (via dialysate) every dialysis treatment and one receiving conventional dialysate without iron every dialysis treatment. Each study will treat 300 patients, with a one-to-one randomization between SFP and placebo. Study treatment duration will be up to 12 months.
"We are pleased that our positive dialogue with the FDA led to what we believe to be a robust Phase III program," stated Robert L. Chioini, Chairman, CEO and President of Rockwell. "We are very encouraged that the FDA supports our Phase III primary efficacy endpoint, which demonstrated statistical significance in our Phase IIb study. We have submitted our Phase III protocol in its entirety to the Agency and we have made significant progress in site recruitment. As a result, we anticipate commencing the Phase III program within the next 90 days."
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