Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical StudyPR Newswire
October 03, 2007: 08:17 AM EST
WIXOM, Mich., Oct. 3 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. , a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), announced today that it has begun dosing patients in its Phase IIb Dose-Ranging Clinical Study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.
The Phase IIb Clinical Design is a double-blind, multi-center, randomized, placebo-controlled, nine-month study consisting of up to 130 patients at multiple dialysis centers in the United States. The primary end points of the study are to evaluate SFP at varying dosage levels in hemodialysis patients and to determine the optimal concentration of SFP in dialysate that will maintain iron balance within their target hemoglobin range. Secondary end points include evaluating efficacy for changes in hemoglobin levels over time, reticulocyte hemoglobin content, incidence of systemic infection episodes and to quantify the amount of SFP iron transferred from the dialysate directly to the blood during the dialysis session.
Robert L. Chioini, Chairman and CEO of Rockwell stated, "Beginning the successful dosing of dialysis patients is another significant milestone in our clinical path for gaining FDA market approval for SFP. Going forward, we anticipate sharing news of our clinical progress as it becomes available."
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 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 million annually.
About Rockwell Medical
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.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward- looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.
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