EXHIBIT 99.1
[CYTOGEN LOGO]
Company contacts:
Advanced Magnetics, Inc. Cytogen Corporation
Jerome Goldstein, CEO Michael Becker, CEO
or Lisa Gordon, Investor Relations or Stacy Shearer, Investor Relations
(617) 497-2070 (609) 750-8289
STUDY IN NEW ENGLAND JOURNAL OF MEDICINE SHOWS ADVANCED MAGNETICS' COMBIDEX(R)
ENABLES EARLY DIAGNOSIS OF LYMPH NODE METASTASES IN PROSTATE CANCER PATIENTS
Combidex Able to Detect Lymph Node Metastases as Small as 2 Millimeters
CAMBRIDGE, MA, AND PRINCETON, NJ (JUNE 18, 2003) -- Advanced Magnetics, Inc.
(Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) today announced the
publication of clinical data in this week's New England Journal of Medicine
showing that magnetic resonance (MR) imaging with Combidex(R), an
investigational iron oxide nanoparticle, aids in the non-invasive evaluation of
lymph nodes in patients with prostate cancer. Researchers, led by Mukesh
Harisinghani, MD, assistant radiologist at Massachusetts General Hospital (MGH)
and Jelle Barentsz, MD, Professor of Radiology at the University Medical Center
Nijmegen (UMCN) in the Netherlands, concluded that the use of Combidex-enhanced
MR imaging allows for the detection of small and otherwise undetectable lymph
node metastases in patients with prostate cancer.
In an accompanying perspective "New Horizons in Oncologic Imaging" by Koh, et.
al., the authors stated "[these imaging techniques] represent major advances in
cancer imaging, which may help optimize patient care by pinpointing even the
smallest tumors and providing a functional assessment of malignant disease."
"This study provides further evidence of the important role Combidex can play in
the diagnosis and treatment of cancer patients as a critical tool to
differentiate between metastatic and normal lymph nodes. We believe that
Combidex can significantly contribute to helping physicians more accurately
identify the spread of cancer to lymph nodes," stated Jerome Goldstein, Chairman
and Chief Executive Officer of Advanced Magnetics. "The ability to identify
metastatic nodes through the use of Combidex-enhanced MR imaging that might
otherwise be overlooked by current imaging guidelines is a significant step
forward for the oncology community."
The study published by Dr. Harisinghani involved 40 patients from MGH and 40
patients from UMCN with prostate cancer, who were scheduled either for surgical
lymph node resection or nodal biopsy. The researchers performed MR imaging
before and 24 hours after the administration of Combidex. In one of the
evaluations done, the researchers determined whether or not each patient had any
metastatic nodes. For these evaluations on a patient-by-patient basis, when the
before and after MR scans were compared to pathology, the use of
Combidex-enhanced MR imaging improved accuracy from 65% to 98% and improved the
positive predictive value from 60% to 94%. Sensitivity, the probability that the
diagnosis is positive given the presence of disease, increased from 45% to 100%.
Specificity, the likelihood that given the absence of disease the diagnosis is
negative, increased from 79% to 96%. Of the 33 patients in whom metastatic
disease was found, the researchers noted that 9 of those patients had metastatic
lymph nodes outside of the standard area for surgical exploration that would not
have been found by current standard diagnostic procedures.
"This study demonstrates the potential role of Combidex for changing the way
cancer is currently diagnosed and treated, not only in prostate cancer patients
but also across the disease category," commented Michael Becker, President and
Chief Executive Officer of Cytogen Corporation, which has exclusive U.S.
marketing rights to Combidex. "Current treatment guidelines provide for imaging
studies to determine the extent and spread of disease, including to lymph nodes,
for the prognosis and treatment of many cancers. However, the assessment of
lymph node status is currently based on the size of the node. This important new
study further demonstrates that Combidex could fill an unmet medical need for
more accurate ways of differentiating between malignant and non-malignant lymph
nodes. We look forward to bringing Combidex to market and to offering this
non-invasive tool to physicians throughout the United States."
Additionally, the researchers analyzed the results based on the diagnosis of
each individual node. Results of the node-by-node diagnoses with Combidex
resulted in accuracy of 97%, sensitivity of 91%, specificity of 98% and a
positive predictive value of 95%. Of the nodes that were determined malignant by
pathology, 71% were 10 mm or less in size and therefore did not fulfill the
traditional imaging criteria for malignancy. Nodal evaluation using
Combidex-enhanced images for nodes between 5 mm and 10 mm in size resulted in
accuracy of 99%, sensitivity of 96%, specificity of 99% and an increase in the
positive predictive value compared to unenhanced MR images from 29% to 96%. Dr.
Harisinghani and his colleagues also noted that they were able to detect
metastatic disease as small as 2 mm in size which is below the threshold of
detection of any other imaging technique.
For some of the patients in this study, Dr. Harisinghani and his team at MGH
also used the images to develop three-dimensional reconstructions of patient
anatomy that were helpful in identifying both normal and malignant nodes in
relationship to important surgical landmarks such as vessels and nerves.
Utilization of this technique could prove to be an important tool for physicians
performing surgery on these patients.
Computed tomography (CT) and MR imaging 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. Without a lymph-node specific contrast
agent, CT and MR imaging 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.
Previous published findings in patients with breast, head and neck, urologic,
and pelvic cancers have confirmed the potential for improved detection of lymph
node metastases by using Combidex-enhanced imaging when compared to unenhanced
or gadolinium-enhanced MR imaging.
Approximately one in every six men will develop prostate cancer. It is the
second leading cause of cancer death among men in the United States, exceeded
only by lung cancer. The American Cancer Society's Cancer Facts and Figures 2003
estimates that over 220,000 new cases of prostate cancer will be diagnosed this
year in the United States, and that approximately 29,000 men will die of the
disease.
Combidex, the lead product in Advanced Magnetics' development pipeline, received
an approvable letter, subject to certain conditions, from the U.S. Food and Drug
Administration (FDA) for use in the diagnosis of lymph node disease. Advanced
Magnetics continues to work with the FDA to resolve the outstanding issues from
the approvable letter in an effort to bring Combidex to the market.
ABOUT ADVANCED MAGNETICS, INC.
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 www.advancedmagnetics.com
ABOUT CYTOGEN CORPORATION
Cytogen Corporation of Princeton, NJ is a product-driven, oncology-focused
biopharmaceutical company. Cytogen markets proprietary and licensed oncology
products through its in-house specialty sales force: ProstaScint(R) (a
monoclonal antibody-based imaging agent used to image the extent and spread of
prostate cancer) and NMP22(R) BladderChek(TM) (a point-of-care, in vitro
diagnostic test for bladder cancer). Cytogen has also developed Quadramet(R), a
skeletal targeting therapeutic radiopharmaceutical for the relief of bone pain
in prostate and other types of cancer, for which the company receives royalties
on product sales through Berlex Laboratories, the U.S. affiliate of Schering AG
Germany, which markets the product in the United States. Cytogen has exclusive
U.S. marketing rights to Combidex(R), an ultrasmall superparamagnetic iron oxide
contrast agent for magnetic resonance imaging of lymph nodes. Cytogen's pipeline
comprises product candidates at various stages of clinical development,
including fully human monoclonal antibodies and cancer vaccines based on PSMA
(prostate specific membrane antigen) technology, which was exclusively licensed
from Memorial Sloan-Kettering Cancer Center. Cytogen also conducts research in
cell signaling through its AxCell Biosciences research division in Newtown, PA.
For more information, please visit the Company's website at www.cytogen.com,
which is not part of this press release.
FOR ADVANCED MAGNETICS:
This document contains forward-looking statements. 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
the Company's ability to resolve the outstanding issues from the approvable
letter received from the FDA for Combidex, the timing and results of FDA actions
regarding Combidex, uncertainties regarding market acceptance of Combidex,
uncertainties relating to patents and proprietary rights and other risks
identified in Advanced Magnetics, Inc.'s Securities and Exchange Commission
filings. The Company 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. The study described herein is not part of the FDA's
review of Combidex.
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. The words "anticipates," "believes," "estimates," "expects,"
"intends," "may," "plans," "projects," "will," "would" and similar expressions
are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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. The
Company cannot guarantee that the Company will actually achieve the plans,
intentions or expectations disclosed in any such forward-looking statements. The
Company's actual results may differ materially from the Company's historical
results of operations and those discussed in the forward-looking statements for
various reasons, including, but not limited to, the Company's ability to carry
out its business and financial plans, to obtain any necessary financing for the
reacquisition of U.S. marketing rights to Quadramet(R), to determine and
implement the appropriate strategic initiative for its AxCell Biosciences
subsidiary, to fund development necessary for existing products and to pursue
new product opportunities, the risk of whether products result from development
activities, protection of its intellectual property portfolio, ability to
integrate in-licensed products such as NMP22(R) BladderChek(TM), ability to
establish and successfully complete clinical trials where required for product
approval, the risk associated with obtaining the necessary regulatory approvals,
shifts in the regulatory environment affecting sales of the Company's products
such as third-party payor reimbursement issues, dependence on the Company's
partners for development of certain projects, the ability to obtain foreign
regulatory approvals for products and to establish marketing arrangements in
countries where approval is obtained, and other factors discussed in the
Company's Form 10-K for the year ended December 31, 2002, as amended, and from
time-to-time in the Company's other filings with the Securities and Exchange
Commission. Any forward-looking statements made by the Company do not reflect
the potential impact of any future acquisitions, mergers, dispositions, joint
ventures or investments the Company may make. The Company does not assume, and
specifically disclaims, any obligation to update any forward-looking statements,
and these statements represent the Company's current outlook only as of the date
given.
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