WIXOM, Mich., Oct. 13, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI - News), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that an abstract on SFP, its lead drug candidate, has been accepted for presentation at the American Society of Nephrology (ASN) meeting to be held in San Diego CA, October 27 - November 1, 2009.
Data will be presented during the ASN meeting for the Company's investigational drug, SFP, which is being studied for the treatment of iron-deficiency anemia in ESRD patients. The new in-vitro data demonstrate that SFP-derived iron binds rapidly and completely within minutes to transferrin. Transferrin is the carrier protein that delivers iron directly to the bone marrow for hemoglobin generation in the human body. In contrast, current IV-iron carbohydrate complexes administered intravenously undergo uptake by the liver, spleen and lymph nodes (reticuloendothelial system) followed by processing and slow release of iron for use by the body. SFP's rapid and direct binding to transferrin is thought to have the potential to prevent or reduce iron-induced oxidative stress and iron acquisition by bacteria, while overcoming reticuloendothelial block and thereby improving responsiveness to erythropoiesis stimulating agents. The full abstract is available on the ASN website at www.asn-online.org.
"We are excited to share these data on SFP at the ASN meeting this year," stated Robert L. Chioini, Chairman and CEO of Rockwell. "We are focused on bringing this new iron maintenance therapy to all ESRD patients and remain on track to complete our Phase 2b study for SFP at the end of this October."
The following abstract will be presented as a poster at this year's ASN meeting:
Gupta et al. "Fe (III) Transfer from Soluble Ferric Pyrophosphate (SFP) to Human Apotransferrin," Saturday, October 31, 10:00 am - 12:00 pm (Poster SA-PO2433)
About SFP:
SFP is a novel, investigational, physiological iron maintenance 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, healthy dietary iron uptake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to offset iron losses 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 and benefits of recombinant erythropoietin treatment. Rockwell has licensed exclusive world-wide rights to manufacture and sell SFP and has secured patents 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 $850 million.
About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
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