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Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
Date:9/19/2007

ng this important work. Dosing is expected to begin in less than two weeks. As information is obtained from our Data Safety Monitoring Board it will be presented to the scientific and investment communities."

Enrollment in the Phase IIb dose ranging study commenced following successful completion of an extensive pre-clinical safety, pharmacology and toxicology study program.

About Soluble Ferric Pyrophosphate (SFP)

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron-maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell, that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Based on previous human clinical study results, and compared to intravenous (IV) iron administration, Rockwell has shown that SFP can deliver iron via dialysate as a safe and effective method for maintaining iron balance in dialysis patients within the target iron range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to the SFP and is collaborating with the FDA in its development. Patents for SFP have been secured in the United States, Japan and the European Union covering the three largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $450 million annually while the global market potential is approximately $750 mill
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SOURCE Rockwell Medical Technologies, Inc.
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