Rockwell Medicals' independent Data Safety Monitoring Board (DSMB) has recommended in providing oversight for the company's phase III SFP iron replacement therapy programme 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-centre 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.
Robert L Chioini, chairman and CEO stated, “We are pleased to receive this positive news from the DSMB and thank the members for their effort. With this positive DSMB news, along with recent verification that the planned sample size for the study is sufficient, we are confident that we are in good position to complete a successful phase III programme. By delivering SFP iron via dialysate, we expect this novel iron replacement therapy will benefit all ESRD patients suffering from iron deficiency.”
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency and secondary hyperparathyroidism.