CAMBRIDGE, Mass., Nov. 1 /PRNewswire-FirstCall/ -- Advanced Magnetics today announced that the Data Monitoring Committee (DMC) for the ferumoxytol Phase III iron replacement therapy program has independently met to review initial safety data and has recommended that the studies continue with no modifications.
Advanced Magnetics announced the formation of the DMC in August to provide independent oversight of the Company’s development program for ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis.
The DMC informed the Company that it has carefully reviewed the data and has identified no safety concerns. The DMC also recommended that the Phase III studies continue with no modifications, according to James Kaufman, MD, Co- Chair of the DMC.
“We appreciate the work being done by the DMC and we will continue to benefit from their oversight, as well as the guidance of our Scientific Advisory Board,” said Jerome Goldstein, Chairman, President and CEO of Advanced Magnetics. “This recommendation bolsters our belief in the potential of ferumoxytol as an IV iron replacement therapeutic and our efforts to successfully complete our Phase III 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 cardiovascular disease and cancer. 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.
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding the safety of ferumoxytol as an iron replacement therapeutic, the benefits we receive from the role of the Scientific Advisory Board and the Data Monitoring Committee, our belief in the potential of ferumoxytol as an IV iron replacement therapeutic, and our ability to successfully complete development of and obtain FDA approval for ferumoxytol, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the clinical development of ferumoxytol, one of our two products currently under development, or may not be able to complete the development in a timely or cost-effective manner, due to the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) uncertainties surrounding the timing and results of FDA interactions regarding the clinical development of ferumoxytol and our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) uncertainties relating to our ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing ferumoxytol; and (5) uncertainties relating to patents and proprietary rights and other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact: Lisa Gordon, VP of Business Development Advanced Magnetics, Inc. (617) 497-2070 lgordon@advancedmagnetics.com
Advanced Magnetics, Inc.
CONTACT: Lisa Gordon, VP of Business Development of Advanced Magnetics,Inc., +1-617-497-2070, lgordon@advancedmagnetics.com
Web site: http://www.advancedmagnetics.com//
