The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Patients receiving ferumoxytol had a significantly greater mean increase in hemoglobin compared to patients in the oral iron group
Ferumoxytol was well tolerated with repeated dosing. Adverse events occurred in 52% of oral iron patients compared to 35.5% of ferumoxytol patients.
“These early results are encouraging, and we will continue our efforts to successfully complete the phase III development program for ferumoxytol,” stated Brian Pereira, president and CEO of Advanced Magnetics.
The company currently expects to complete enrollment in its last remaining phase III study in hemodialysis-dependent chronic kidney disease patients, by the end of the first quarter of calendar 2007. The company plans to submit a new drug application for ferumoxytol during the second half of calendar 2007.