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The Phase IIb, double-blinded, randomized, placebo-controlled, 6-month duration, dose ranging study enrolled patients at 29 sites in the U.S. and Canada. 131 ESRD patients receiving chronic hemodialysis were dosed at 0, 5, 10, 12, or 15 ug of SFP-derived iron per deciliter of dialysate. The objective of the study was to evaluate the safety of SFP at varying dose levels and to determine the optimal concentration of SFP for maintenance of hemoglobin in the target range by maintaining iron balance. Two Data Safety Monitoring Board reviews of interim study data did not identify any safety concerns nor necessitate any change in the study design or conduct, and the study advanced until the targeted patient enrollment was achieved.
Mr. Robert L. Chioini, Chairman and CEO of Rockwell Medical, commented, "We are pleased to have completed our phase IIb study. We have seen an encouraging safety profile for SFP to date and we anticipate having un-blinded data from the study in the first quarter of 2010."
About SFP:
SFP is a novel, investigational, continuous iron 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, physiologic dietary iron intake. 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 to erythropoiesis stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. 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:
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 healthy 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 the SFP technology for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773
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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Rockwell Medical Technologies, Inc.
CONTACT: The Trout Group LLC Brian Korb, VP (646) 378-2923 LaVoie Group Media Contact: Lisa Rivero, Director, Media Relations (978)745-4200 ext. 106
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