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WIXOM, Mich., May 25, 2010 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.
The SFP Phase IIb data were submitted as a late-breaking clinical trial abstract. The acceptance of the abstract for the meeting is noteworthy, as only significant clinical trials of extraordinary importance are considered for presentation.
Phase IIb data will be presented during the ERA-EDTA meeting for Rockwell's investigational drug SFP, which is being studied as an iron replacement product for maintaining hemoglobin in the target range while reducing erythropoiesis stimulating agent (ESA) dosage in adult hemodialysis-dependent chronic kidney disease (CKD-HD) patients. The data will be presented in the poster area of the International Congress Centre Munich on June 26, 2010, number Sa681. Dr. Ajay Gupta, Chief Scientific Officer, and Dr. Richard Yocum, VP of Drug Development, will be present throughout the two official poster sessions from 10:30 to 11:15 hrs. and from 16:15 to 17:00 hrs.
"We are looking forward to sharing this SFP data at the ERA-EDTA meeting in June," stated Dr. Richard Yocum, VP of Clinical Development at Rockwell. "We are focused on bringing SFP, a novel continuous iron maintenance therapy, to the worldwide ESRD patient population. After our upcoming meeting with the FDA, we hope to initiate our Phase III clinical program in the second-half of this year."
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 replenish iron lost 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 Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued 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.