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Last Update: 04-Feb-13 10:25 ET
Rockwell Medical Up Over 7% After Positive Drug News
Rockwell Medical (RMTI $6.92 +0.47) announced iron delivery drug SFP meets primary endpoint in PRIME clinical study demonstrating statistically significant 37% reduction in ESA dose (6.45 ) Co announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients. The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% while maintaining iron balance and maximizing iron delivery.
The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate. A total of 103 patients received blinded study drug (52 SFP, 51 Placebo; modified ITT population). In each group, 11 subjects discontinued prematurely. Discontinuations due to adverse events were 2 in SFP and 3 in placebo. The reasons for the remaining discontinuations were similar between treatment groups. The baseline hemoglobin was similar in both groups (10.9 g/dL SFP and 11.1 g/dL placebo). In all study patients, ESA doses were titrated to maintain hemoglobin in a target range of 9.5 to 11.5 g/dL according to an algorithm managed by an independent centralized anemia management group. At the end of treatment, the hemoglobin value in the SFP group was 10.5 g/dL and 10.4 g/dL in the placebo group. Intravenous (IV) iron was administered as needed to treat iron deficiency.
The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate. A total of 103 patients received blinded study drug (52 SFP, 51 Placebo; modified ITT population). In each group, 11 subjects discontinued prematurely. Discontinuations due to adverse events were 2 in SFP and 3 in placebo. The reasons for the remaining discontinuations were similar between treatment groups. The baseline hemoglobin was similar in both groups (10.9 g/dL SFP and 11.1 g/dL placebo). In all study patients, ESA doses were titrated to maintain hemoglobin in a target range of 9.5 to 11.5 g/dL according to an algorithm managed by an independent centralized anemia management group. At the end of treatment, the hemoglobin value in the SFP group was 10.5 g/dL and 10.4 g/dL in the placebo group. Intravenous (IV) iron was administered as needed to treat iron deficiency.
