WIXOM, Mich., Jan. 31, 2008 (PRIME NEWSWIRE) -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI) a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products focused on the end-stage-renal-disease (ESRD) market, announced today that the National Institutes of Health (NIH) sponsored clinical study for Soluble Ferric Pyrophosphate (SFP), Rockwell's physiological iron-maintenance-therapy drug, has entered active treatment phase with the initiation of dosing.
The clinical design is a 9-month, 30-patient, prospective, randomized, open-label, multi-center, controlled clinical trial of the safety and efficacy of physiological iron maintenance in ESRD subjects by delivery of SFP via hemodialysate. ESRD subjects receiving maintenance hemodialysis will be enrolled and randomized to receive hemodialysis using dialysate solutions with SFP or conventional solutions lacking iron at every dialysis session with the goal of maintaining iron balance within a tight hemoglobin range.
Primary end-points: * Efficacy: The amount of therapeutic IV iron needed by subjects in the group receiving SFP in their dialysate versus those who do not. * Safety: Safety and tolerability determined by clinically significant changes on vital signs, clinical laboratory measures, and incidence and severity of adverse events. Secondary end-points: * Hemoglobin maintenance and variability within optimal target range. * Efficiency of iron delivery to the erythron. * Incidence and time to development of iron deficiency and iron overload. * Markers of inflammation and oxidative stress.
Robert L. Chioini, Chairman and CEO of Rockwell stated, "Beginning the successful dosing of dialysis patients in this NIH sponsored study is another significant milestone in our clinical path for gaining FDA market approval for SFP. We expect to share news of our clinical progress as it becomes available."
About National Institutes of Health
The National Institutes of Health (NIH), http://www.nih.gov, a part of the U.S. Department of Health and Human Services, is the primary federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH sponsored scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.
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. Compared to intravenous (IV) iron administration, previous human clinical study results indicate that SFP can deliver iron (via dialysate) safely and effectively and can maintain iron balance in dialysis patients within the target 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 SFP and is seeking FDA market approval. Patents for SFP have been secured in the United States, Japan and the European Union covering the largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $480 million annually while the global market potential is approximately $800 million annually.
About Rockwell Medical Technologies, Inc.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary formulations for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These novel technologies are designed to deliver safe and effective renal therapy to ESRD patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate(r) Dry Acid Concentrate Mixing System, RenalPure(r) Liquid Acid Concentrate, SteriLyte(r) Liquid Bicarbonate Concentrate, RenalPure(r) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at www.rockwellmed.com for more information.
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