CAMBRIDGE, Mass., and PRINCETON, N.J., Oct. 5 /PRNewswire-FirstCall/ --
Advanced Magnetics, Inc. (Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO)
today announced that COMBIDEX(R) (Sinerem(R) in Europe, ferumoxtran-10) is the
subject of several abstracts accepted for presentation at both the 46th Annual
Meeting of the American Society for Therapeutic Radiation and Oncology (ASTRO)
held October 3 through October 7, 2004 in Atlanta, GA and the 90th Scientific
Assembly and Annual Meeting of the Radiological Society of North America
(RSNA), to be held November 28 through December 3, 2004 in Chicago, IL.
Several of the abstracts demonstrate the role that COMBIDEX can play in
conjunction with MRI to aid in the differentiation of cancerous from non-
cancerous lymph nodes.
Two abstracts posted by ASTRO on its Web site,
http://astro.abstractsnet.com/, can be accessed through the search function as
"Combidex," "ferumoxtran-10" or "USPIO."
Similarly, the text of six RSNA abstracts can be accessed on its Web site,
http://rsna2004.rsna.org, through the search function as "Combidex"
"ferumoxtran-10" or "Sinerem."
The content of these abstracts and of the websites of ASTRO and RSNA are
not part of this press release.
Background Information
COMBIDEX (ferumoxtran-10) is an investigational 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 non-
cancerous lymph nodes. Lymph nodes are frequently the site for metastases of
many different types of cancer, particularly breast cancer and prostate
cancer. Computed tomography (CT) and MRI are the methods currently used for
imaging lymph nodes. Current guidelines for imaging lymph nodes are that
nodes greater than 10 mm in size are usually deemed cancerous while nodes less
than 10 mm in size are generally presumed normal. CT and MRI cannot
distinguish between lymph nodes that are enlarged due to the infiltration of
cancerous cells as opposed to inflammation nor can these methods reliably
detect disease in nodes that are not enlarged. Clinical studies have shown
that COMBIDEX accumulates in non-cancerous lymph node tissue which could
enable doctors using MRI to have improved diagnostic confidence in
differentiating between normal and diseased lymph nodes. COMBIDEX received an
approvable letter from the FDA, subject to certain conditions, in June of
2000. In June 2004, Advanced Magnetics submitted a response to the approvable
letter received from the U.S. Food and Drug Administration (FDA) for COMBIDEX,
and is in the process of providing the FDA with additional details underlying
supporting data in the submission in order to provide a complete response to
the approvable letter.
About Advanced Magnetics
Advanced Magnetics, Inc. is the premier developer of superparamagnetic
iron oxide nanoparticles used in pharmaceutical products. As a leader in its
field, Advanced Magnetics is dedicated to the development and
commercialization of its 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 Advanced Magnetics, please visit the company's website at
http://www.advancedmagnetics.com, the content of which is not part of this
press release.
About Cytogen Corporation
Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven,
oncology-focused biopharmaceutical company that develops and commercializes a
balanced portfolio of oncology products that address the unmet medical needs
of patients and their physicians. Cytogen's marketed products include
QUADRAMET(TM) (samarium Sm-153 lexidronam injection) and PROSTASCINT(R)
(capromab pendetide) kit for the preparation of Indium In-111 capromab
pendetide in the United States. Cytogen has exclusive United States marketing
rights to COMBIDEX(R) (ferumoxtran-10), an investigational molecular imaging
agent consisting of iron oxide nanoparticles for use in conjunction with
magnetic resonance imaging to aid in the differentiation of cancerous and non-
cancerous lymph nodes, which is under review by the U.S. Food and Drug
Administration. Cytogen is also developing therapeutics targeting prostate-
specific membrane antigen (PSMA), a protein highly expressed on the surface of
prostate cancer cells and the neovasculature of solid tumors. Full
prescribing information for the Company's products is available at
http://www.cytogen.com or by calling 1-800-833-3533. For more information,
please visit the Company's website at http://www.cytogen.com, which is not
part of this press release.
For Advanced Magnetics
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 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: uncertainties relating to Advanced Magnetics' ability
to successfully address the comments and concerns of the FDA contained in the
approvable letter for COMBIDEX, including uncertainties relating to the
sufficiency of the additional details to be submitted to the FDA by Advanced
Magnetics; the timing of FDA actions regarding COMBIDEX, including the timing
of its review of the supporting data or the additional details submitted in
relation thereto; the outcome of FDA actions in response to the submission,
including the possibility that the FDA will not consider the submission
complete or that the FDA will require additional information in support of the
submission; the possibility that even if the response is deemed complete by
the FDA, the FDA could respond to this submission by issuing an additional
approvable letter with additional conditions for approval or the FDA could
issue a not approvable letter; the ability to resolve final labeling for
COMBIDEX with the FDA; uncertainties regarding market acceptance of COMBIDEX;
uncertainties relating to third-party reimbursements; uncertainties relating
to Advanced Magnetics' ability to continue to operate at commercial scale in
compliance with FDA regulations and other applicable manufacturing
requirements; uncertainties relating to patents and proprietary rights and
other risks identified in Advanced Magnetics, Inc.'s Securities and Exchange
Commission filings. Advanced Magnetics cautions readers not to place undue
reliance on any forward-looking statements which speak only as of the date
they are made. Advanced Magnetics disclaims 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.
For Cytogen
This press release contains certain "forward-looking" statements within
the meaning of the Private Securities Litigation Reform Act of 1995 and
Section 21E of the Securities Exchange Act of 1934, as amended. All
statements, other than statements of historical facts, included in this press
release regarding our strategy, future operations, financial position, future
revenues, projected costs, prospects, plans and objectives of management are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and investors are cautioned not to put any undue
reliance on any forward-looking statement. There are a number of important
factors that could cause Cytogen's results to differ materially from those
indicated by such forward-looking statements. In particular, Cytogen's
business is subject to a number of significant risks, which include, but are
not limited to: the risk of obtaining the necessary regulatory approvals; the
risk of whether products result from development activities; the risk of
shifts in the regulatory environment affecting sales of Cytogen's products
such as third-party payor reimbursement issues; the risk associated with
Cytogen's dependence on its partners for development of certain projects, as
well as other factors expressed from time to time in Cytogen's periodic
filings with the Securities and Exchange Commission (the "SEC"). As a result,
this press release should be read in conjunction with Cytogen's periodic
filings with the SEC. The forward-looking statements contained herein are made
only as of the date of this press release, and Cytogen undertakes no
obligation to publicly update such forward-looking statements to reflect
subsequent events or circumstances.
SOURCE Cytogen Corporation; Advanced Magnetics, Inc.
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Related links:
http://astro.abstractsnet.com
/Web site: http://rsna2004.rsna.org /Web site:
http://www.advancedmagnetics.com http://www.cytogen.com
CONTACT:
Advanced Magnetics, Inc.: Jerome Goldstein,
CEO or Lisa Gordon, Investor Relations, +1-617-497-2070; or
Cytogen Corporation: Michael Becker, CEO or Stacy Shearer,
Investor Relations, +1-609-750-8289
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