Rockwell Medical Data Safety Monitoring Board Recommends SFP Phase III Efficacy Studies to Continue as Planned
Rockwell Medical (Nasdaq: RMTI) today announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the Company's Phase III SFP iron replacement therapy program met and informed the company that it has carefully reviewed the cumulative safety data from the Phase III CRUISE studies and identified no safety concerns. The DSMB also recommended the continuation of the Phase III CRUISE studies with no modifications. SFP, a key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an iron replacement therapeutic in ESRD patients.
Separately, an interim analysis of the blinded and pooled data of the two SFP Phase III studies (CRUISE 1 and 2) revealed that the standard deviation of the hemoglobin change from baseline is less than 1 g/dL. In each of the two CRUISE studies the calculated sample size of 133 patients in each treatment group was based on a projected standard deviation of 1.25 g/dL. Because the actual standard deviation is less than projected, there is no need for an increase in sample size.
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