The first phase III study demonstrated a statistically significant achievement of all primary and secondary endpoints. Additionally, all primary and secondary endpoints were achieved with statistical significance in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
The second phase III study enrolled 750 patients, including both dialysis-dependent chronic kidney disease (CKD) patients and non-dialysis dependent CKD patients, who received either one 510mg dose of ferumoxytol or intravenous placebo at day zero and received the other treatment at day seven. The primary safety analysis was the descriptive comparison of adverse events experienced during ferumoxytol and placebo administration. Treatment related adverse events occurred in 37 patients after ferumoxytol treatment and in 30 patients after placebo treatment. Treatment related serious adverse events, as determined by the investigator, occurred in one patient after ferumoxytol treatment and in one patient after placebo treatment.
“The data from these studies are very promising because they demonstrate a statistically significant improvement in hemoglobin levels for non-dialysis dependent CKD patients undergoing ferumoxytol therapy as compared to oral iron therapy. In my opinion, the results from these two new studies, in conjunction with previous clinical trials, support an attractive profile for ferumoxytol,” stated Allen Nissenson, director of the Dialysis Program at David Geffen School of Medicine.
Advanced Magnetics said it remained on track to file a new drug application for ferumoxytol in the fourth calendar quarter of 2007.