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WIXOM, Mich., Aug. 16, 2010 (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, reported today that it has added Iain Macdougall, BSc(Hons), MD, FRCP to its Scientific Advisory Board (SAB). Rockwell's SAB currently advises the Company on clinical development for its investigational continuous iron-maintenance drug Soluble Ferric Pyrophosphate (SFP), currently in late stage FDA clinical development.
Dr. Iain C. Macdougall is a Consultant Nephrologist and Honorary Senior Lecturer at King's College Hospital, London since 1996. His major research interests are in the field of renal anemia. Dr. Macdougall has led numerous Phase I, II and III clinical trials of oral iron, intravenous iron, and ESAs including erythropoietin, darbepoetin, C.E.R.A., and Hematide. Dr. Macdougall has published over 160 peer reviewed research publications and has been a member of both US and European anemia guidelines working groups.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell, stated, "We are especially pleased to have Dr. Macdougall join our SAB, as he brings a wealth of clinical trial experience in the field of iron supplementation and ESA therapy. We are confident that his input will be a great benefit to the SFP clinical development program as we move into Phase III studies this year."
Dr. Macdougall commented, "I am delighted to be part of Rockwell's Scientific Advisory Board. I look forward to providing my input in helping to develop this novel iron treatment, which utilizes a unique mode of delivery for iron supplementation in hemodialysis patients."
SFP is a novel, investigational, continuous iron therapy designed to treat iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal physiologic dietary iron intake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to replenish iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP, delivered during each dialysis treatment via dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response to erythropoiesis-stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued 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.