Advanced Magnetics announces design of phase 3 iron therapy program for ferumoxytol

By Lisa Kerner

Erie, Pa., March 3 - Advanced Magnetics, Inc. said the primary efficacy analysis for the three phase 3 efficacy studies of ferumoxytol as an intravenous iron replacement therapeutic will be the comparison of the mean change in hemoglobin from baseline between ferumoxytol and oral iron.

Based on this primary efficacy analysis, established with guidance from the Food and Drug Administration, fewer patients than originally anticipated will be enrolled in the ferumoxytol chronic kidney disease and hemodialysis efficacy studies.

Each of the three phase 3 efficacy studies has two treatment groups: one receiving two 510 mg doses of ferumoxytol and one receiving 200 mg of elemental iron daily for three weeks, according to a company news release.

"We are very encouraged by our positive discussions with the FDA," president Brian J.G. Pereira said in the release. "We plan to continue this productive dialogue with the FDA as we move our iron replacement therapy program forward."

Advanced Magnetics, based in Cambridge, Mass., develops superparamagnetic iron oxide nanoparticles used in pharmaceutical products.

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