Advanced Magnetics' Ferumoxytol Data Monitoring Committee Identifies No Safety Concerns
Ferumoxytol, the key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an intravenous (IV) iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis.
"We are pleased with the continued recommendations from the DMC regarding our Phase III development program for ferumoxytol," stated Brian J.G. Pereira, MD, President of Advanced Magnetics. "We are encouraged by its report to us and remain committed to the successful completion of our Phase III development program."
Advanced Magnetics announced the formation of the DMC in August of 2005 to provide independent oversight of the company's development program for ferumoxytol as an IV iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis. The DMC has also met to review cumulative safety data in October 2005 and February 2006. At both of these meetings, the DMC identified no safety concerns and recommended the continuation of the Phase III studies with no modifications. At all meetings, the DMC has available to it data on adverse events, serious adverse events and patient disposition.
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.
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 our commitment to the successful completion of our Phase III development program, 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, 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) the possibility that we may not be able to raise additional capital on terms and on a timeframe acceptable to us, if at all; (5) uncertainties relating to our patents and proprietary rights; and (6) 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.
Advanced Magnetics
http://www.advancedmagnetics.com
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