• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Rockwell Medical Technologies, Inc. Announces Patient Enrollment Begins for NIH Funded SFP Clinical Study

Posted on: Wednesday, 23 January 2008, 09:01 CST

WIXOM, Mich., Jan. 23, 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 patient enrollment has started for a National Institutes of Health (NIH) sponsored clinical study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.

Dr. Mordechai S. Nosrati, MD, Associate Professor of Clinical Medicine at Keck-USC School of Medicine and co-principal investigator stated, "SFP in dialysate allows for the slow infusion of iron over a 4-hour dialysis session and physiologically mimics how the human body normally handles and processes dietary iron, thereby potentially mitigating the side effects associated with intravenous iron such as release of free iron and excess storage of iron in the liver. I'm very excited to participate in the study of this revolutionary advancement in iron delivery."

The NIH sponsored study is a 9-month, 30-patient, two-site, randomized, controlled, clinical study that will examine maintenance of hemoglobin, iron parameters, need for intravenous iron and oxidative stress markers in patients receiving SFP via dialysate versus patients receiving conventional iron-free dialysate. New data from this important study is expected to be published in late 2008.

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.

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 September 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.

This news release was distributed by PrimeNewswire, www.primenewswire.com

CONTACT: Rockwell Medical Technologies, Inc. Investor Relations Ronald J. Aubrey (866) 565-6139 Thomas Klema, CFO (248) 960-9009

Source: PrimeNewswire

More News in this Category