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Rockwell Medical Inc Announces SFP Phase 3 Efficacy Study CRUISE-1 Completes Patient Dosing


Wednesday, 29 May 2013 08:04am EDT 

Rockwell Medical Inc announced that CRUISE-1 Phase 3 efficacy study for SFP has completed patient dosing. SFP is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. CRUISE-1 top-line data is expected in July 2013. Completing the CRUISE-1 efficacy study is a achievement for Rockwell, and are excited to be so close to top-line results, stated Robert L. Chioini, Founder, Chairman and CEO of Rockwell Medical. SFP is a promising iron drug that will address the unmet need for correcting functional iron deficiency in CKD-HD patients. The results of the placebo controlled PRIME study, recently reported at the ERA-EDTA Congress in Istanbul, demonstrated that SFP reduced the ESA dose required to maintain hemoglobin by a statistically significant 35% compared to placebo. The CRUISE studies do not allow changes in ESA dosing, so it is confident that in the CRUISE study design, SFP will show a favorable difference in hemoglobin levels compared to placebo. Rockwell is conducting two pivotal Phase 3 efficacy studies called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult CKD patients requiring hemodialysis. Each study comprises approximately 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. 

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