Wixom, Mich — Biopharmaceutical company Rockwell Medical, offering products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, has announced that the clinical research divisions of the two largest dialysis companies in North America — DaVita and Fresenius Medical Care —  have signed agreements to participate in the company’s pivotal Phase III Continuous Replacement Using Iron Soluble Equivalents (CRUISE) studies using Soluble Ferric Pyrophosphate (SFP) as a continuous iron-replacement therapeutic.

Robert L. Chioini, chairman and CEO, stated, "We are pleased to have these companies participate in our pivotal SFP Phase III studies.
Together, they provide ongoing dialysis treatment to approximately two-thirds of hemodialysis patients in the U.S. We expect their access
to a large number of patients and their expertise in clinical research will enable us to achieve timely enrollment and complete a successful
Phase III clinical program."

Rockwell will conduct two pivotal Phase III trials for SFP. Each study is a prospective, randomized, double-blinded, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate in adult CKD patients requiring hemodialysis. Each study will comprise 300 patients, randomized equally between SFP and placebo groups over a period of up to 12 months.

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 norma 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), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell has licensed exclusive worldwide 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 US dialysis market
for IV iron is approximately $560 million annually while global market potential is approximately $1 billion.

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SOURCE: Rockwell Medical