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www.fdanews.com/articles/67649-advanced-magnetics-begins-large-scale-phase-iii-safety-study-of-ferumoxytol-in-iv-iron-replacement-therapy

ADVANCED MAGNETICS BEGINS LARGE-SCALE PHASE III SAFETY STUDY OF FERUMOXYTOL IN IV IRON REPLACEMENT THERAPY

January 17, 2005

Advanced Magnetics has initiated a large-scale, multicenter Phase III safety study for ferumoxytol, the company's next-generation product in its development pipeline, for use as an intravenous iron replacement therapeutic in anemic chronic kidney disease patients, regardless of whether they are on dialysis.

The multicenter clinical trial is a double-blind, crossover design study comparing ferumoxytol to placebo. Ferumoxytol consists of intravenously administered, bioavailable iron that allows for more efficient replenishment of the body's iron stores than oral iron supplements without the common side effects associated with oral iron. Ferumoxytol also provides greater flexibility in both the administration and the amount of iron that can be given to a patient in comparison to other intravenous iron replacement products currently on the market.