WIXOM, Mich., June 17, 2008 (PRIME NEWSWIRE) -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI), a specialty pharma company focused on drug and device development in the renal market, reported today that it has added Dr. James D. Cook, an internationally recognized expert in the field of iron, to its Scientific Advisory Board (SAB). Dr. Cook has published over 200 peer-reviewed articles on all aspects of human iron metabolism with emphasis on iron absorption, internal iron kinetics and the clinical assessment of iron status in a career spanning over 40 years. Rockwell's SAB currently advises the Company on clinical development and market preparation for its proprietary iron-maintenance product SFP, currently in Phase IIb clinical trials. Rockwell's SAB consists of experts in the fields of renal anemia, iron therapy, nephrology and FDA regulatory approval.
Dr. Cook graduated from Queen's University, Canada with an M.D. degree in 1960 and M.Sc (Med) in 1963. He obtained his clinical training in Internal Medicine at Boston City Hospital and hematology training at the University of Washington, Seattle where he remained on faculty until 1975. He was then appointed the Phillips Professor of Medical Research and Director of Hematology, Department of Medicine at the Kansas University Medical Center, Kansas City, Kansas. Dr. Cook retired from teaching and clinical practice as Professor Emeritus at Kansas University in 2007.
In the late 1960s Dr. Cook, in collaboration with Dr. Joseph Eschbach, studied disorders of erythropoiesis and iron absorption in patients with kidney failure. In his distinguished career, Dr. Cook has served as Chairman on several national and international research/advisory committees including the Expert Panel on Iron, International Committee for Standardization in Hematology (1981); Subcommittee on Nutritional Anemia, American Society of Hematology (1979); Subcommittee on Iron Methodology, National Committee for Clinical and Laboratory Standards (1979-95); International Center for Control of Nutritional Anemia (ICCNA), University of Kansas Medical Center (1982-94), and Iron Subcommittee, FAO/WHO Expert Consultation on Requirements of Vitamin A, Iron, Folate and Vitamin B12 (1985). Dr. Cook has also served as a member/consultant on the Editorial Board, Journal of Nutrition (1978-1983); NIH Hematology Study Section (1983-1987), Tanzania Nutritional Anemia Consultative Group, Dar es Salaam, Tanzania (1991-92); US National Committee, International Union of Nutritional Sciences (1986-1992); Joint Micronutrient Consultative Group, Nutrition Foundation (1992-94); British Task Force on Iron Nutrition (1992-93); National Nutrition Council, Stockholm, Sweden (1993); Scientific Subcommittee on Iron and Heme, American Society of Hematology (2001-2004); and International Federation of Clinical Chemistry Working Group on Laboratory Management of r-HuEPO Therapy (2002-2005).
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are excited to have added Dr. Cook to our SAB. Dr. Cook's expertise and wealth of experience in the iron field will be invaluable to Rockwell as the Company further exploits the unique properties of SFP that make it ideally suited for the oral, nutritional and parenteral and enteral administration markets. We have assembled a first-class team to help facilitate not only FDA market approval of SFP in ESRD but to also pursue regulatory approval of other SFP applications within CKD and other new markets as well."
Rockwell's current SAB consists of:
* Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology and Senior Staff Physician, Henry Ford Hospital, Detroit and lead Principal Investigator for the Phase IIb dose range study. * Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of Medicine, Indianapolis. * Richard Zager, MD, Director of Nephrology, Fred Hutchinson Cancer Research Center and Professor of Medicine, University of Washington, Seattle. * James Cook, MD, former Phillips Professor of Medical Research and Director of Hematology, and currently Professor Emeritus, Kansas University, Kansas City, Kansas. * Bert Spilker, PhD, MD, President Bert Spilker & Associates, LLC. * Ajay Gupta, MD, Associate Professor of Medicine, UCLA and Charles Drew University Schools of Medicine, Los Angeles; the inventor of SFP as a parenteral iron supplement (via hemodialysis and peritoneal dialysis solutions, intravenously and as an adjunct to parenteral nutritional admixtures. Dr. Gupta is the Principal Investigator for the ongoing NIH sponsored clinical trial examining oxidative stress and inflammation in response to SFP versus IV iron.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide physiological-iron-maintenance-therapy for treatment of anemia, with initial indication for end stage renal disease (ESRD). SFP is delivered direct to the bloodstream of the ESRD patient, via dialysate, during each kidney dialysis treatment, maintaining optimal iron balance, avoiding liver toxicity and decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.
The Company is currently conducting a Phase IIb study and sponsoring an on-going NIH-funded study in anticipation of gaining FDA market approval. Rockwell has licensed exclusive world-wide rights 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. The U.S. dialysis market for IV-iron delivery is approximately $500 million annually while global market potential is approximately $800 million.
Rockwell 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 who suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and 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 is currently developing unique, proprietary renal drug therapies for both iron maintenance and carnitine supplementation utilizing its dialysate as the delivery mechanism. 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 to these patients while decreasing cost. Visit 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. 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. 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 the Company's 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. The forward-looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and 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.