WIXOM, Mich., Sept. 19 /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 commenced enrollment in its Phase IIb dose-ranging study for Soluble Ferric Pyrophosphate (SFP), a physiological iron-maintenance therapy drug.
The Phase IIb dose-ranging study is a nine-month, controlled multi-center, double-blind study consisting of up to 130 patients at multiple dialysis centers in the United States. Patients will receive SFP during their normal three times/week dialysis regimen. The primary objectives of this study are to evaluate both safety and efficacy of SFP at varying dosage levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range, in patients undergoing hemodialysis. Secondary endpoints 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. Results of this Phase IIb study are expected by the end of 2008.
Robert L. Chioini, Chairman and CEO of Rockwell stated, “We are excited to initiate this important step in our clinical development plan for SFP, a key product in Rockwell’s renal drug development pipeline. The completion of this study will enable us to initiate our planned Phase III pivotal study program for FDA market approval of SFP. Mr. Chioini also stated, “We have assembled a team of top-tier investigators who will be conducting 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 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.
Rockwell Medical Technologies, Inc.
CONTACT: Ron Aubrey, Investor Relations, +1-866-565-6139, or Thomas Klema,+1-248-960-9009, both of Rockwell Medical Technologies, Inc.
Web site: http://www.rockwellmed.com/
