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

ferumoxytol had a significantly greater mean increase in hemoglobin compared to patients receiving oral iron (ferumoxytol 1.24 +/- 1.25 g/dl vs. oral iron 0.50 +/- 0.98 g/dl, p<0.0001). * Ferumoxytol was more likely to increase baseline hemoglobin by greater than or equal to 1 g/dl compared to oral iron (52.9% of ferumoxytol patients vs. 18.2% of oral iron patients, p<0.0001). * Mean increase in serum ferritin from baseline was significantly greater in the ferumoxytol group compared to the oral iron group at Day 21 (ferumoxytol 416.0 +/- 249.0 ng/ml vs. oral iron 4.3 +/- 48.2 ng/ml, p<0.0001). * Stratifying by ESP use, there was a significantly greater increase in hemoglobin at Day 35 for ferumoxytol compared to oral iron in both patients who were on ESPs and those who were not on ESPs. * In patients on a stable ESP dose, mean hemoglobin increase at Day 35 was 1.66 +/- 1.38 g/dl for ferumoxytol compared to 0.82 +/- 1.28 g/dl for oral iron (p=0.0024). In addition, 66.3% of patients treated with ferumoxytol experienced an increase of +/- 1 g/dl in hemoglobin compared to 35.3% of patients treated with oral iron (p=0.0017). * Similarly, in patients not treated with ESPs, mean hemoglobin increase at Day 35 was 0.93 +/- 1.05 g/dl for ferumoxytol compared to 0.25 +/- 0.56 g/dl for oral iron (p<0.0001). In addition, 43.1% of patients treated with ferumoxytol alone experienced an increase of greater than or equal to 1 g/dl in hemoglobin compared to 4.7% of patients treated with oral iron alone (p<0.0001).

Ferumoxytol was well tolerated with repeated dosing (2 x 510 mg). Adverse events occurred in 55.5% of ferumoxytol patients compared to 59.5% of oral iron patients. Drug-related adverse events occurred in 21.4% of ferumoxytol patients compared to 16.2% o
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