Advanced Magnetics Completes Enrollment in Final Planned Phase III Study of Ferumoxytol as an IV Iron Replacement Therapeutic
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- Category: Small Molecules
- Published on Tuesday, 20 March 2007 02:00
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CAMBRIDGE, MA, USA | Mar 19, 2007 | Advanced Magnetics (NASDAQ: AMAG) today announced that it has completed enrollment in a clinical study of ferumoxytol in 230 dialysis-dependent chronic kidney disease (DD-CKD) patients. The trial is the fourth and final planned multi-center study in the company’s Phase III development program for ferumoxytol, an intravenous (IV) iron replacement therapeutic for the treatment of anemia in chronic kidney disease (CKD) patients.
In this study, protocol 62,475-5, patients 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 primary endpoint is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
With completion of enrollment in the DD-CKD trial, the company remains on schedule to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for the marketing approval of ferumoxytol in the fourth calendar quarter of 2007. The company plans to submit data from over 1,600 CKD patients studied in the overall Phase III program to demonstrate ferumoxytol’s safety and clinical benefit.
“Having achieved the important milestone of completing patient enrollment in our Phase III development program, we now look forward to presenting results from multiple trials in the weeks and months ahead, and remain focused on the day that ferumoxytol might become available to all chronic kidney disease patients and physicians,” stated Brian J.G. Pereira, M.D., Advanced Magnetics’ President and Chief Executive Officer.
Advanced Magnetics’ Phase III development program for ferumoxytol is comprised of four clinical trials; three with efficacy and safety endpoints, and one with only safety endpoints.
Results from the three completed Phase III ferumoxytol trials will be presented on Wednesday, April 11 during the National Kidney Foundation (NKF) 2007 Spring Clinical Meetings in Orlando, Florida. Two posters containing the data from the following trials are scheduled to be presented on Wednesday, April 11, 2007 at approximately 5:30 pm ET:
• Two safety and efficacy studies, protocols 62,475-6 and 62,475-7, each of which enrolled 304 non dialysis-dependent (NDD-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. The primary endpoint of these studies is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
• A large scale safety study in both DD-CKD and NDD-CKD patients, protocol 62,745-8, which enrolled 750 patients in a double-blind, placebo-controlled, crossover safety study comparing a single dose of 510 mg ferumoxytol to placebo.
The company plans to issue a press release summarizing the data to be presented at the NKF meeting after market close on Wednesday, April 11, 2007. The announcement will be followed by a conference call at 4:30 pm ET to discuss and answer questions regarding the data from the completed studies and the status of the ferumoxytol development program.
About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.
SOURCE: Advanced Magnetics