CAMBRIDGE, Mass.,-- Advanced Magnetics announced positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic that is being presented at the American Society of Nephrology's Renal Week 2006 Annual Meeting in San Diego, CA. A poster entitled "Ferumoxytol as Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis -- Evaluation of Safety and Efficacy in Two Phase III Studies" is being presented today at 10:00 am PT. The study enrolled 304 non dialysis-dependent chronic kidney disease patients (NDD-CKD) 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. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all primary and secondary endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
So what does this say?:
Anemia is common in patients with advanced chronic kidney disease (CKD) and can lead to a variety of detrimental effects. In addition to the direct effects of anemia on performance and ischemic symptoms, it has also been suggested that mortality and major complications during end-stage renal disease (ESRD) are associated with anemia that develops early in the course of CKD. Correcting anemia before the initiation of renal replacement therapy (RRT) may improve health outcomes.
Iron deficiency is treatable and failure to replete iron stores may result in resistance to erythropoietin.
AMAG closed friday trading up up $13.10 dollars per share or 29%. In after hours trading the trend continued as it went up another 45 cents to close at $57.45. I'm keeping my eye on this company for the letter of approval from the FDA in the future. I will post if I pull the trigger on the stock.
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