Rockwell Medical (RMTI) Reports Positive Phase II Clinical Trials
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Rockwell Medical (Nasdaq: RMTI) summarized findings from its completed Phase IIb clinical study. The study evaluated Soluble Ferric Pyrophosphate (SFP), the Company's proprietary investigational product for continuous iron maintenance therapy in chronic hemodialysis (HD) patients.
The Phase IIb study showed SFP was well-tolerated without apparent toxicity and there was overwhelming evidence of dose-dependent SFP-derived iron transfer and uptake based on iron parameters as surrogate markers of efficacy. Although one of the primary endpoints of the study, a decrease in hemoglobin of at least 1.0 g/dL, was not met, primarily due to the study design, the other primary endpoint was achieved with the demonstration of safety across all dose groups. The study also met its objective of determining the dosing of SFP for the planned Phase III trials.
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The Phase IIb study showed SFP was well-tolerated without apparent toxicity and there was overwhelming evidence of dose-dependent SFP-derived iron transfer and uptake based on iron parameters as surrogate markers of efficacy. Although one of the primary endpoints of the study, a decrease in hemoglobin of at least 1.0 g/dL, was not met, primarily due to the study design, the other primary endpoint was achieved with the demonstration of safety across all dose groups. The study also met its objective of determining the dosing of SFP for the planned Phase III trials.
[SM]
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