Final Patient Treated in Phase 3 Trial
Rockwell Medical, 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, secondary hyperparathyroidism and hemodialysis, announced that patient dosing has completed in its PRIME clinical study, which is designed to investigate the reduction in the need for erythropoiesis stimulating agents (ESAs) in hemodialysis patients receiving soluble ferric pyrophosphate (SFP) via dialysate. SFP is Rockwell's late-stage investigational drug currently in Phase 3 clinical study.
Robert L. Chioini, Chairman and CEO of Rockwell, stated "We are excited to achieve another important milestone in our SFP clinical development program. We look forward to the upcoming PRIME study results this quarter, followed by the results from our two pivotal Phase 3 CRUISE studies later this year."
The PRIME study is a nine-month, multi-center study in the U.S. that randomized 100 patients equally to dialysate containing SFP-iron versus conventional dialysate. The primary objective of the study is to determine whether regular administration of SFP-iron via dialysate reduces the requirement for ESA's by maintaining iron balance and optimizing iron delivery. Important markers of inflammation and oxidative stress will also be measured.
Date: January 7, 2013
Source: Rockwell Medical