Advanced Magnetics Presents Data on Iron Replacement Therapy
Advanced Magnetics announced positive results from two additional Phase III clinical trials of ferumoxytol as an intravenous (IV) iron replacement therapeutic. The findings were presented at the National Kidney Foundation's Spring Clinical Meeting.
One study involved 303 non-dialysis-dependent chronic kidney disease (CKD) patients who were randomized to receive either two 510-mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks.
This Phase III study demonstrated a statistically significant achievement of all primary and secondary endpoints. Additionally, all primary and secondary endpoints were achieved with statistical significance in patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
The second trial was a double-blind, placebo-controlled, crossover, Phase III study that enrolled a total of 750 patients, including both dialysis-dependent CKD patients and non-dialysis-dependent CKD patients, who received either one 510-mg dose of ferumoxytol or IV placebo (saline) at day zero and received the other treatment at day seven.
The primary safety analysis was the descriptive comparison of adverse events (AEs) experienced during ferumoxytol and placebo administration. Treatment-related AEs occurred in 37 patients (5.2 percent) after ferumoxytol treatment and in 30 patients (4.2 percent) after placebo treatment. Treatment-related serious adverse events, as determined by the investigator, occurred in one patient after ferumoxytol treatment and in one patient after placebo treatment.
"We have now presented data from three of the four studies in the pivotal program for ferumoxytol," Brian Pereira, president and CEO of Advanced Magnetics, said. "These new results are encouraging, and we remain on track to file our [new drug application] for ferumoxytol in the fourth calendar quarter of 2007."