Advanced Magnetics completes enrollment in two phase 3 studies of ferumoxytol

New York, Sept. 5 - Advanced Magnetics said it completed enrollment in two of four multi-center phase 3 clinical studies of ferumoxytol as an intravenous iron replacement therapeutic for the treatment of anemia in chronic kidney disease patients, whether or not on dialysis.

One study enrolled 304 non-dialysis-dependent chronic kidney disease patients. The primary endpoint in the study is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.

The second study enrolled 750 dialysis-dependent and non-dialysis dependent chronic kidney disease patients in a double-blind, placebo-controlled, crossover safety study.

Additional milestones for the phase 3 ferumoxytol iron therapy program include completion of enrollment in the second multi-center study in non-dialysis-dependent chronic kidney disease patients, currently planned for the end of calendar 2006 and completion of enrollment in the multi-center study in hemodialysis dependent chronic kidney disease patients, currently planned for early 2007, the Cambridge, Mass., developer of superparamagnetic iron oxide nanoparticles for pharmaceutical products said.

The next meeting of the Data Monitoring Committee overseeing the ferumoxytol phase 3 iron therapy program is scheduled for October.

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