The company is organizing two pivotal prospective, randomized, double-blinded, placebo-controlled, multicenter study Phase III trials CRUISE-1 and CRUISE-2.
Each study expects to recruit around 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months.
The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.
Rockwell chairman and CEO Robert Chioini said enrolling patients in CRUISE-1 in the first quarter of 2011 keeps their clinical development timeline for SFP on target.