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Advanced Magnetics Announces Positive Results from Two Additional,Phase III Studies of Ferumoxytol as an Intravenous Iron Replacement,Therapeutic

f oral iron patients. Serious adverse events occurred in 7.7% of ferumoxytol patients compared to 13.5% of oral iron patients. There were no drug-related SAEs in ferumoxytol treated patients. There was one drug-related SAE in one oral iron treated patient (1.4%); a case of severe gastritis which led to discontinuation of the study drug.

Safety Study in CKD Poster

The second poster shows results from a double-blind, placebo-controlled, crossover safety study in dialysis- dependent CKD and non-dialysis dependent CKD patients (Protocol 62,745-8; ClinicalTrials.gov identifier NCT00255450). Complete safety data was available for 360 patients randomized to the ferumoxytol to placebo sequence and for 362 patients randomized to the placebo to ferumoxytol sequence. For the ferumoxytol to placebo sequence, 40.3% of patients had dialysis-dependent CKD, and for the placebo to ferumoxytol sequence 43.6% of patients had dialysis-dependent CKD. The results from this safety study showed:

      * There were no meaningful mean changes in vital signs on laboratory

        values from baseline for patients after either ferumoxytol or placebo

        administration.


      * AEs occurred in 21.3% of patients after ferumoxytol administration and

        in 16.3% of patients after placebo administration.  On a blinded

        basis, these were deemed to be related to treatment by the

        investigator in 5.2% of patients after ferumoxytol and in 4.2% of

        patients after placebo.


      * SAEs occurred in 2.9% of patients after ferumoxytol administration and

        in 1.8% of patients after placebo administration.  On a blinded basis,

        these SAEs were deemed to be related to treatment by the investigator

        in one patient (0.1%) after ferumoxytol and in one patient (0.1%)

        after placebo.


      * The single SAE attributed to the drug after ferumoxytol administration

        occurred in an 85 year-old male, with non-dialysis
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