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Advanced Magnetics Announces Design of Phase III Iron Therapy Program for Ferumoxytol |
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03 Mar 2006 |
CAMBRIDGE, MA, USA | Mar 03, 2006 | Advanced Magnetics, Inc. (Amex: AVM) today announced the design of its Phase III development program for ferumoxytol as an intravenous iron replacement therapeutic following a series of communications with the U.S. Food and Drug Administration (FDA).
With guidance from the FDA given during a recent telephone conference, Advanced Magnetics has established that the primary efficacy analysis for the three Phase III efficacy studies will be the comparison of the mean change in hemoglobin from baseline between ferumoxytol and oral iron. Based on this primary efficacy analysis, fewer patients will need to be enrolled in the ferumoxytol chronic kidney disease (CKD) and hemodialysis (HD) efficacy studies than the company anticipated at the time of its August 2005 press release. Each of the three Phase III efficacy studies has two treatment groups: one receiving two 510 mg doses of ferumoxytol and one receiving 200 mg of elemental iron daily for three weeks. Advanced Magnetics also established the overall number of subjects to be provided in the integrated safety database as part of the company's New Drug Application (NDA) for ferumoxytol as an intravenous iron replacement therapeutic.
"We are very encouraged by our positive discussions with the FDA," stated Brian J.G. Pereira, MD, President of Advanced Magnetics. "We plan to continue this productive dialogue with the FDA as we move our iron replacement therapy program forward."
Ferumoxytol, the key product in Advanced Magnetics' development pipeline, is in Phase III multi-center clinical trials for use as an iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis.
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, Inc |
