Advanced Magnetics' Ferumoxytol Data Monitoring Committee Identifies No Safety Concerns
June 14 2006 - 8:59AM
PR Newswire (US)
- Recommends Continuation of Phase III Studies - CAMBRIDGE, Mass.,
June 14 /PRNewswire-FirstCall/ -- Advanced Magnetics (AMEX:AVM)
today announced that the independent Data Monitoring Committee
(DMC) providing oversight for the ferumoxytol Phase III iron
replacement therapy program met 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. 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.
Contact: Lisa Gordon, VP of Business Development Advanced
Magnetics, Inc. (617) 498-3321 DATASOURCE: Advanced Magnetics
CONTACT: Lisa Gordon, VP of Business Development of Advanced
Magnetics, Inc., +1-617-498-3321, Web site:
http://www.advancedmagnetics.com/
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