WIXOM, Mich., Dec. 4, 2007 (PRIME NEWSWIRE) -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI), a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products, reported today that the FDA has approved initiation of a National Institutes of Health (NIH) sponsored clinical study for Rockwell's proprietary drug-delivery product SFP for chronic hemodialysis patients.
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. Patients in both groups are eligible to receive intermittent intravenous (IV) iron sucrose per protocol if iron deficiency develops. The NIH sponsored study is being conducted by independent investigators and is scheduled to begin shortly with results expected to be published late in 2008.
Dr. Ajay Gupta, lead principal investigator and inventor of SFP stated, "This study will examine the hypothesis that SFP maintains iron balance and hemoglobin while significantly reducing the need for supplemental IV iron and without causing oxidant stress and inflammation."
The National Institutes of Health (NIH), 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 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 SFP (Soluble Ferric Pyrophosphate) - Rockwell's Lead Renal Drug Product
SFP is a water soluble form of iron designed to provide physiological-iron-maintenance-therapy for anemic ESRD patients. SFP is uniquely delivered via dialysate directly to the bloodstream, during each kidney dialysis treatment. The physiological mode of action and ease of delivery of SFP is a highly stable, non-polymeric, simple iron salt that is administered directly into the bloodstream, avoiding liver build-up and toxicity thus 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 which facilitates transfer of iron from transferrin to ferritin, bypassing the liver entirely.
Based on results of an initial Phase II clinical study and compared to IV iron administration, SFP delivered via dialysate, has shown to be a safe and effective method for maintaining optimal iron balance in dialysis patients while at the same time reducing nursing and physician time and pharmaceutical IV iron costs currently associated with IV iron administration. Furthermore, recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is collaborating with the FDA in its development. Rockwell has secured patents for SFP in multiple countries, including the United States, Japan, and the European Union, covering the largest commercial markets in the world for dialysis and iron supplementation. The Company has patents issued and pending in a number of other countries as well.
Rockwell estimates the current U.S. IV-iron market is $480 million and the global IV-iron market is approximately $750 million. The Company believes the U.S IV-iron market has the potential to grow to $1 billion within the next 10 years while the world-wide market could reach $1.5 billion. Rockwell's dialysate products are used as the delivery method for SFP. Rockwell's current share of the U.S. dialysate market is estimated to be 26%.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of renal drug therapies and critical products 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, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary renal drug therapies for both iron-delivery and carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of care for dialysis patients and are designed to deliver safe and effective therapy to 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.