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Advanced Magnetics, Inc. (Nasdaq: AMAG) today announced that it will announce top line results from its final Phase III trial for ferumoxytol as an intravenous (IV) iron replacement therapeutic in the summer of 2007. This study is the fourth and final planned multi-center study in the company's Phase III development program for ferumoxytol in chronic kidney disease patients. The final study, in which enrollment was completed in March 2007, is a 230 patient mutli-center efficacy and safety study in hemodialysis-dependent CKD patients comparing two doses of 510 mg ferumoxytol to daily oral iron. The primary endpoint of the study is the mean change in hemoglobin from baseline on the 35th day following initial treatment in the ferumoxytol group compared to that in the oral iron treatment group. The secondary endpoints for the study include the proportion of subjects experiencing a greater than or equal to one gram per deciliter increase in hemoglobin on the 35th day following initial treatment and the mean change in serum ferritin from baseline on the 21st day following initial treatment, in each case in the ferumoxytol group compared to the oral iron group.
The company remains on schedule to file a New Drug Application (NDA)
with the U.S. Food and Drug Administration for the marketing approval of
ferumoxytol in the fourth calendar quarter of 2007. The company plans to
submit data from over 1,600 chronic kidney disease patients studied in the
overall Phase III program.
Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics, will
be providing an overview of the company at the Jefferies & Company Health
Care Conference being held June 27, 2007 in New York at 12:30 pm ET.
A live audio webcast of this presentation will be accessible through
the Investors section of the company's website at
http://www.advancedmagnetics.com. Following the conference, the audio webcast will
be archived on the Advanced Magnetics website until September 21, 2007.
About Advanced Magnetics, Inc.
Advanced Magnetics, Inc. is a biopharmaceutical company that utilizes
its proprietary nanoparticle technology for the development and
commercialization of therapeutic iron compounds to treat anemia and novel
imaging agents to aid in the diagnosis of cancer and cardiovascular
Ferumoxytol, the company's key product candidate, is being developed
for use as an intravenous iron replacement therapeutic for the treatment of
iron deficiency anemia in chronic kidney disease. The company has completed
enrollment in four Phase III clinical trials with ferumoxytol and has
presented data on three of the four trials.
Combidex, the company's other product under development, is an
investigational functional molecular imaging agent consisting of iron oxide
nanoparticles for use in conjunction with magnetic resonance imaging (MRI)
to aid in the differentiation of cancerous from normal lymph nodes. In
March 2005, the company received an approvable letter from the FDA with
respect to Combidex, subject to certain conditions.
The company has two commercial products, Feridex I.V.(R) and
GastroMARK(R), both of which are imaging agents that are approved and
marketed in the United States, Europe and other countries.
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 herein that do not describe
historical facts, including but not limited to, statements regarding our
intent to publicly announce additional top line Phase III data for
ferumoxytol by the end of the summer 2007, statements regarding our plans
to submit data from over 1,600 chronic kidney disease patients to the FDA
as part of our NDA, and statements regarding our plan to file an NDA for
ferumoxytol with the FDA during the fourth quarter of 2007 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 development of ferumoxytol, or may not be able to complete the
development in a timely or cost-effective manner, due to deficiencies in
the design or oversight by us of these trials, the failure of our trials to
demonstrate that ferumoxytol is safe and efficacious, unexpected results
from our clinical sites, inadequate performance by third-party service
providers, 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 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 fact that we have limited sales and marketing experience; (5) the
possibility that we may not be able to timely or cost-effectively resolve
the questions raised by the FDA and satisfy the conditions specified for
approval of Combidex; (6) uncertainties surrounding the reimbursement for
our products and product candidates by governmental and private third party
payors; (7) uncertainties relating to our patents and proprietary rights;
and (8) other risks identified in our Securities and Exchange Commission
filings. We caution you 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
For more information, please click here
Advanced Magnetics, Inc.
125 CambridgePark Drive
Cambridge, MA 02140
(617) 499-3361 (fax)
61 Mooney St.
Cambridge, MA 02138
(617) 547-2445 (fax)
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