WIXOM, Mich., Oct. 29, 2008 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI), a specialty pharma company focused on drug and device development in the renal market, reported today that the independent Data Safety Monitoring Board (DSMB) providing oversight for the SFP Phase II-b iron maintenance therapy dose-range study reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns. The DSMB also recommended the continuation of the study with no modifications.
"We are encouraged by the DSMB's favorable comments regarding our current Phase II-b iron maintenance therapy dose-range study. We are pleased with the safety profile of SFP. Amongst all clinical studies to date, more than 1,500 clinical doses of SFP have been administered without a single adverse reaction," stated Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell. "In an effort increase the speed of patient enrollment and to complete the trial more rapidly we have increased the number of clinical trial sites to 25-30, from 10. The successful completion of our SFP development program remains our top priority."
About SFP:
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 FDA 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 total U.S. market for IV-iron is approximately $525 million annually while global market potential is approximately $800 million.
About Rockwell Medical Technologies:
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 necessary nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for iron maintenance 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 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.