Healthcare Industry News: intravenous iron replacement
News Release - March 5, 2007
Advanced Magnetics' Ferumoxytol Data Monitoring Committee Identifies No Safety Concerns in Final Data ReviewRecommends Continuation of Phase III Studies
CAMBRIDGE, Mass., March 5 (HSMN NewsFeed) -- Advanced Magnetics (Nasdaq: AMAG ) today announced that the independent Data Monitoring Committee (DMC) providing oversight of the ferumoxytol Phase III intravenous iron replacement therapy program met for the final time and informed the company that it has carefully reviewed the cumulative safety data from the ferumoxytol Phase III studies and identified no safety concerns. The DMC also recommended the continuation of the ferumoxytol Phase III studies with no modifications. At this meeting, the DMC reviewed safety data from 1,610 subjects enrolled in the Phase III program.
The DMC also met to review cumulative safety data in October 2005, February 2006, June 2006 and October 2006. At each 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 had available to it data on all adverse events, serious adverse events and patient disposition.
"We appreciate the diligent oversight of the ferumoxytol Phase III program by the DMC over the past year and a half, and we thank them for their efforts," said Brian Pereira, CEO and President of Advanced Magnetics. "This final recommendation by the DMC reinforces our belief in the potential of ferumoxytol as an IV iron replacement therapeutic as we work toward enrolling the final patients in the Phase III program and preparing the NDA submission for ferumoxytol."
Ferumoxytol, the key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an intravenous 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.
This press release 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 belief in the potential of ferumoxytol as an IV iron replacement therapeutic, enrollment of the final patient in the Phase III program, and the filing of the NDA 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, or may not be able to complete the development in a timely or cost-effective manner, due to the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, 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) the possibility that the results of past ferumoxytol studies may not be replicated in future studies;(3) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner; (4) the fact that we lack sales and marketing expertise; (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.
Source: Advanced Magnetics
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