Advanced Magnetics Says Drug Trials Positive; Shares Up
CAMBRIDGE, Mass., April 11 -- Advanced Magnetics (Nasdaq: AMAG - News) today announced positive results from two additional Phase III clinical trials of ferumoxytol as an intravenous (IV) iron replacement therapeutic that are being presented today at approximately 6:00 pm EDT as posters at the National Kidney Foundation's Spring Clinical Meeting in Orlando, Florida. These posters are available in the investor section on the company's web site at http://www.advancedmagnetics.com.
The first poster, "Evaluation of the Efficacy and Safety of Ferumoxytol as an Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis" shows results from 303 non-dialysis dependent 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 both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs. These new results are consistent with the results previously presented at the American Society of Nephrology's Renal Week in San Diego, CA in November 2006 from another study in non-dialysis dependent CKD patients with an identical protocol.
The second poster, "Evaluation of the Safety of Intravenous Ferumoxytol for Iron Replacement Therapy in Chronic Kidney Disease (CKD)" shows results from a double-blind, placebo-controlled, crossover Phase III study which 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%) after ferumoxytol treatment and in 30 patients (4.2%) after placebo treatment. Treatment related serious adverse events (SAEs), as determined by the investigator, occurred in one patient (0.1%) after ferumoxytol treatment and in one patient (0.1%) after placebo treatment.
"The data from these studies are very promising because they demonstrate a statistically significant improvement in hemoglobin levels for non-dialysis dependent CKD patients undergoing ferumoxytol therapy as compared to oral iron therapy. In my opinion, the results from these two new studies, in conjunction with previous clinical trials, support an attractive profile for ferumoxytol," stated Allen Nissenson, MD, Professor of Medicine and Director of the Dialysis Program at David Geffen School of Medicine at UCLA and Chair of the Ferumoxytol Scientific Advisory Board.
"We are very pleased with the results that we are presenting today at the National Kidney Foundation meeting," stated Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics. "We have now presented data from three of the four studies in the pivotal program for ferumoxytol. These new results are encouraging, and we remain on track to file our NDA for ferumoxytol in the fourth calendar quarter of 2007."
Efficacy and Safety Study in Non-Dialysis Dependent CKD Poster
The first poster shows results from the second of two efficacy and safety studies in non-dialysis dependent CKD patients (Protocol 62,745-7; ClinicalTrials.gov identifier NCT00255437). Efficacy results in the intent to treat (ITT) and efficacy evaluable populations were similar. Efficacy results from the ITT analysis showed:
* For the primary endpoint, which is change in hemoglobin from baseline at Day 35, patients receiving 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