Rockwell Medical (NASDAQ: RMTI) today announced positive safety results of its large Phase 3 short-term safety study that was conducted in support of the New Drug Application for marketing approval of Triferic™. Triferic™ is the Company’s late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.
“We are very pleased with the results of the short-term safety study,” stated Mr. Rob Chioini, Founder, Chairman and CEO of Rockwell. “Triferic’s™ clean safety profile together with its unique mode of action enabling efficient iron delivery and hemoglobin maintenance, while significantly reducing the need for ESA, highlight its potential to be the market-leading iron therapy treatment for CKD-HD patients.”
“We continue to be impressed with Triferic™ and its safety profile,” stated Dr. Ray Pratt, CMO of Rockwell. “Our clinical program is easily the largest and longest cohort of any parenteral iron drug and after 100,000 accumulated administrations we have not seen a single acute safety signal or anaphylactic reaction. This additional safety data, coupled with the successful Phase 3 CRUISE studies and ongoing open-label study, gives us great confidence that Triferic™ can provide dialysis patients safe, effective iron therapy.”
This safety study was a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, Phase 3 study with an enrollment of 718 CKD-HD patients in the US and Canada. It is followed by an ongoing optional open-label, uncontrolled extension study. Consistent with expectations, this study demonstrated that: Triferic™ reliably delivers iron via dialysate. There were no specific adverse events directly attributable to Triferic™. The adverse events during Triferic™ administration were those common in CKD-HD patients. No difference in type, frequency, severity or resolution of adverse events between Triferic™ and placebo. No anaphylaxis or hypersensitivity attributable to Triferic™. No evidence of changes in hepatic enzymes between Triferic™ and placebo. No evidence of first use events or an increase in hypotension.
In conclusion, the safety profile of Triferic™ is no different from placebo in this large, short-term safety study. Triferic™ shows no acute safety signals when administered via dialysate. The results of this study will be presented at the upcoming American Society of Nephrology meeting in Atlanta, GA November 6-10 2013.
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