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WIXOM, Mich., Feb. 16, 2011 (GLOBE NEWSWIRE) -- 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 that it has commenced enrollment in its clinical study designed to investigate reduction in the need for erythropoietin stimulating agents (ESA) in hemodialysis patients receiving Soluble Ferric Pyrophosphate (SFP) via dialysate.
The PRIME study, a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study will randomize 100 patients equally to dialysate containing SFP-iron
versus conventional dialysate. In all study patients, ESA dose may be titrated to maintain hemoglobin in the target range and intravenous iron may be administered as needed to maintain iron balance. The primary objective of the study is to determine whether regular administration of SFP via the dialysate reduces the requirement for erythropoietin stimulating agents (ESA's) by maintaining iron balance and optimizing iron delivery. The primary end point is percent change from baseline in ESA dose required to maintain Hgb in the target range. Secondary endpoints include ESA response index (ERI), measures of oxidative stress, hemoglobin variability and amount of supplemental intravenous iron needed. Results of the PRIME study are expected mid-2012.
Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are excited to initiate the PRIME study. The study is expected to generate compelling clinical and marketing data using a design that mirrors clinical practice. Demonstrating ESA sparing should differentiate SFP as a superior choice for iron-maintenance therapy in chronic hemodialysis patients, once FDA approved."
SFP is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency anemia in ESRD patients. In contrast to intravenous (IV) iron delivery, SFP is a proprietary, water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake. SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trial data to date suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Academic studies have shown that more frequent maintenance doses of iron improve therapeutic response to erythropoiesis-stimulating agents (ESA's), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell has licensed exclusive world-wide rights to manufacture and sell SFP and has obtained patent protection for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $1 billion.