Advanced Magnetics Modifies Phase III Development Program for Ferumoxytol in IV Iron Replacement Therapy; Appoints Scientific Ad
August 11 2005 - 9:00AM
PR Newswire (US)
CAMBRIDGE, Mass., Aug. 11 /PRNewswire-FirstCall/ -- Advanced
Magnetics, Inc. (AMEX:AVM) today announced that after a recent
meeting with the U.S. Food and Drug Administration (FDA) to
evaluate its Phase III development program for ferumoxytol in IV
iron replacement therapy, the company plans to revise the program
to include a new primary efficacy analysis suggested by the FDA.
The revised efficacy analysis is consistent with the analysis upon
which a recent approval of another IV iron product was based. These
modifications will result in additional patients being enrolled in
the ferumoxytol chronic kidney disease (CKD) efficacy studies and
will involve the re-design of the hemodialysis protocol currently
under way. The Company also plans to add additional patients to the
large-scale safety study in order to provide a more robust safety
database for the New Drug Application (NDA). Based on the currently
planned revisions to the ferumoxytol development program, the
Company projects an addition of $5 to $7 million to the total
budget for the Phase III program and a submission of the NDA in mid
2007. The Company plans to continue its ongoing dialogue with the
FDA to ensure a clear regulatory path for submission, review and
approval of the NDA for ferumoxytol as an iron replacement
therapeutic. "We believe that what we have learned in our
discussions with the FDA, combined with our review of a recent iron
product approval, provides us with a clearer understanding of what
it will take to bring ferumoxytol through the approval process,"
stated Jerome Goldstein, Chairman, President and CEO of Advanced
Magnetics. "We are leveraging our existing resources, including the
funds raised in the Company's June 2005 financing, to expand our
capabilities and ensure the successful development of ferumoxytol
in IV iron replacement therapy." Adds Scientific Advisory Board,
Data Monitoring Committee Advanced Magnetics also announced that it
has assembled a Scientific Advisory Board (SAB) to advise the
company on clinical development, market preparation, pre-launch and
other strategic activities in its efforts to complete its Phase III
development program for ferumoxytol. The SAB will be comprised of:
* Allen R. Nissenson, MD, FACP, FAHA, Professor of Medicine and
Director of the Dialysis Program at the David Geffen School of
Medicine, University of California, Los Angeles as Chair of the
SAB; * Vaidyanathapuram Balakrishnan, MD, MRCP, PhD, Assistant
Professor of Medicine, Tufts University School of Medicine and
Staff Physician, Division of Nephrology, Tufts-New England Medical
Center; * Anatole Besarab, MD, Director of Clinical Research,
Division of Nephrology and Senior Staff Physician, Henry Ford
Hospital; * Allan Collins, MD, FACP, Director, United States Renal
Data System (USRDS) and Professor of Medicine, University of
Minnesota School of Medicine; * Bertrand L. Jaber, MD, FASN, Vice
Chairman for Clinical Affairs, Department of Medicine, Caritas St.
Elizabeth's Medical Center and Associate Professor of Medicine,
Tufts University School of Medicine; * Robert Provenzano, MD, FACP,
Clinical Associate Professor of Medicine, Wayne State University
School of Medicine, Chief of the Section of Nephrology,
Hypertension and Transplantation, St. John Hospital and Medical
Center and President of the Renal Physicians Association; and *
Ravi Thadhani, MD, MPH, Associate Professor of Medicine, Harvard
Medical School and Director of Clinical Research in Nephrology,
Massachusetts General Hospital. "We have assembled an outstanding
group of world-class nephrologists and clinicians to advise us as
we progress through our Phase III development program for
ferumoxytol in IV iron replacement therapy," stated Brian J.G.
Pereira, MD, President and Chief Executive Officer, NEHCF,
Tufts-News England Medical Center, Professor of Medicine, Tufts
University School of Medicine, and member of the Board of Directors
at Advanced Magnetics. "The Scientific Advisory Board will play an
important role in the achievement of both the short- and long-term
milestones for ferumoxytol through commercial launch of the
product. We are very excited that such outstanding individuals have
joined us to aid in our efforts to develop and commercialize
ferumoxytol as an iron replacement therapeutic." Additionally,
Advanced Magnetics announced that it has assembled a Data
Monitoring Committee (DMC) to provide independent oversight of the
Phase III iron therapy program. The DMC will be comprised of: *
Marc Pohl, MD, Ray W. Gifford MD Endowed Chair in Hypertension,
Head, Section of Clinical Hypertension, Department of Nephrology
and Hypertension, Cleveland Clinic Foundation, as DMC chair; *
James Kaufman, MD, Staff Physician, Renal Section, VA Boston
Healthcare System and Professor of Medicine, Boston University
School of Medicine; and * Christopher H. Schmid, PhD, Associate
Professor, Tufts University and Senior Statistician, Institute for
Clinical Research and Health Policy Studies, Tufts-New England
Medical Center. 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 changes
to the primary efficacy analysis for our Phase III clinical trials
for ferumoxytol in iron therapy, the need to enroll additional
patients in our Phase III efficacy and safety studies for
ferumoxytol, the proposed re-design of the hemodialysis protocol,
the amount of the projected increase in the budget for the Phase
III ferumoxytol development program, the projected date for filing
the NDA for ferumoxytol, the role of the Scientific Advisory Board
and the Data Monitoring Committee, and our ability to 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: Jerome Goldstein, CEO or Lisa Gordon, VP of Business
Development Advanced Magnetics, Inc. (617) 497-2070 DATASOURCE:
Advanced Magnetics, Inc. CONTACT: Jerome Goldstein, CEO or Lisa
Gordon, VP of Business Development, , both of Advanced Magnetics,
Inc., +1-617-497-2070 Web site: http://www.advancedmagnetics.com/
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