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New Data from Clinical Trials Involving PROSTASCINT(R) and QUADRAMET(R) in Multiple Cancers Presented at 50th Annual Meeting of SNM Investigational Studies Detail New Advances in Molecular Imaging Technology for Prostate Cancer with PROSTASCINT and P
PRINCETON, N.J., Jun 25, 2003 /PRNewswire-FirstCall via COMTEX/ -- Cytogen
Corporation (Nasdaq: CYTO), a product-driven, oncology-focused biopharmaceutical
company, today announced that clinical investigators from cancer research
centers around the world presented new clinical data on PROSTASCINT(R) (Capromab
Pendetide) and QUADRAMET(R) (Samarium Sm 153 Lexidronam) in multiple cancers at
the 50th Annual Meeting of the Society of Nuclear Medicine (SNM). The
presentations were held from Saturday, June 21 through Wednesday, June 25 in New
Orleans, LA and involved either investigational applications or recent
experience with the Company's proprietary and licensed molecular imaging and
therapeutic products.
"We have previously communicated that future potential growth for PROSTASCINT
and QUADRAMET are largely dependent upon, among other things, the implementation
and continued research of several activities," said Michael D. Becker, President
and Chief Executive Officer of Cytogen Corporation. "The presentations conducted
this week by independent researchers at the largest meeting of nuclear medicine
physicians and scientists provide excellent examples of progress in these areas.
Equally important, the marketing alliances that Cytogen announced earlier this
week provide new opportunities to drive future potential growth by fostering
increased awareness of recent advances in molecular imaging."
PROSTASCINT
PROSTASCINT is a murine monoclonal antibody linked to the radioisotope
Indium-111 that specifically targets prostate-specific membrane antigen (PSMA).
A radioisotope is an element, which, because of nuclear instability, undergoes
radioactive decay and emits radiation. Due to the selective expression of PSMA
by prostate cancer cells, the PROSTASCINT imaging procedure can image the extent
and spread of prostate cancer in the body.
SNM presentations regarding PROSTASCINT related mainly to fusion imaging and
image enhancements. Fusion imaging is an image processing technique that
combines functional information from a PROSTASCINT scan with anatomic images
provided by CT (computed tomography) or MR (magnetic resonance) scans in a
digital overlay to provide information that cannot be achieved with separate
imaging modalities alone, which may improve diagnostic interpretation. Image
enhancements are designed to improve the quality of single photon emission
computed tomography (SPECT) images through reconstruction and attenuation-
correction methods that address the inherent limitations of SPECT imaging by
correcting for the effects of radiation scatter and/or inherent collimator and
detector blur.
GE Medical Systems and Cytogen Announce Marketing Alliance Prostate Molecular Imaging Technology to be Made Available to Broader Range of Customers
NEW ORLEANS, WAUKESHA, Wis., and PRINCETON, N.J., Jun 24, 2003
/PRNewswire-FirstCall via COMTEX/ -- GE Medical Systems, a unit of General
Electric Company (NYSE: GE), announced at the 50th Annual Meeting of the Society
of Nuclear Medicine that it has formed an alliance with Cytogen Corporation
(Nasdaq: CYTO) to market a total molecular imaging system to help evaluate the
extent and spread of prostate cancer by integrating GE Medical's Infinia(TM)
Hawkeye(R) imaging system with Cytogen's ProstaScint(R) imaging agent.
GE's revolutionary Infinia Hawkeye imaging system combines the anatomic detail
of computed tomography (CT) with the molecular imaging data provided by nuclear
medicine cameras using products such as Cytogen's ProstaScint. Infinia Hawkeye
provides CT-based attenuation correction and localization for single-photon
emission computed tomography (SPECT) studies that can help address the inherent
limitations of SPECT imaging.
ProstaScint is a radiolabeled monoclonal antibody that specifically targets
prostate-specific membrane antigen (PSMA). Due to the enhanced expression of
PSMA by prostate cancer cells, the ProstaScint molecular imaging procedure can
detect the cancer's extent and spread, particularly to lymph nodes, one of the
common first sites of prostate cancer metastases in the body.
"The combining of CT data with ProstaScint SPECT data provides valuable
additional guidance to the clinician in evaluating potential tumor sites," said
Professor Keith E. Britton, MD, Head of the Nuclear Medicine Department at St.
Bartholomew's Hospital in London, UK. "This technique will also be useful in
enhancing other radioimmunoscintigraphic studies, such as the imaging of colon
and ovarian cancer."
"ProstaScint is a key contributor to the success of Infinia Hawkeye SPECT/CT
molecular imaging of the prostate," said Jeff Kao, General Manager, Nuclear
Medicine, GE Medical Systems. "We are pleased to show our customers how GE and
Cytogen products can offer physicians improved diagnostic confidence."
The new GE/Cytogen relationship will allow the advanced technology of
ProstaScint molecular imaging to reach a broader base of customers. The
agreement provides that both parties will work together to advance patient and
physician awareness of fusion imaging. GE Medical Systems will maintain
installation and customer service activities, while Cytogen will provide
technical support for ProstaScint fusion imaging.
There are more than 200 GE Hawkeye SPECT/CT systems installed globally. Leading
medical centers that offer ProstaScint fusion imaging on this system in the
United States are located in such cities as New York (tri-state area), San
Francisco, Baltimore and Houston.
Prostate cancer is the second leading cause of cancer-related death among men.
According to the American Cancer Society, in this year alone, 220,900 men are
expected to be diagnosed with the cancer and approximately 28,900 will die from
the disease.
"The public's growing awareness of the importance of accurately staging the
extent and spread of prostate cancer has been a key factor in the creation of
the GE Medical Systems/Cytogen alliance," said Michael D. Becker, president and
CEO of Cytogen Corporation. "GE Medical Systems is a respected name in medical
imaging technology and equipment, and we are pleased to support molecular
imaging through our technical support specialists. Recent advances in molecular
imaging technology, made possible by novel systems such as the GE Infinia
Hawkeye series, are critical to realizing future potential growth for
ProstaScint by enhancing image quality and addressing the historical limitations
of SPECT agents."
About GE Medical Systems
GE Medical Systems is a $9 billion global leader in medical imaging,
interventional procedures, healthcare services, and information technology. Its
offerings include networking and productivity tools, clinical information
systems, patient monitoring systems, surgery and vascular imaging, conventional
and digital X-ray, computed tomography, electron beam tomography, magnetic
resonance, ultrasound and bone mineral densitometry, positron emission
tomography, nuclear medicine, and a comprehensive portfolio of clinical and
business services. For more than 100 years, health care providers worldwide have
relied on GE Medical Systems for high quality medical technology and
productivity solutions. For more information, visit the GE Medical Systems Web
site at www.gemedical.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
(USPIO) contrast agent for magnetic resonance imaging of lymph nodes that is
pending clearance by the U.S. Food and Drug Administration. 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
cellular 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.
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 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.
SOURCE GE Medical Systems; Cytogen Corporation
Cytogen, Siemens and University Hospitals of Cleveland Join Forces to Promote Breakthroughs in Prostate Cancer Imaging
NEW ORLEANS, Jun 23, 2003 /PRNewswire-FirstCall via COMTEX/ -- Three leaders in
medical innovation -- Cytogen Corporation (Nasdaq: CYTO), Siemens Medical
Solutions (NYSE: SI), and University Hospitals of Cleveland -- today announced a
partnership to promote breakthroughs in prostate cancer imaging.
(Photo: NewsCom: www.newscom.com/cgi-bin/prnh/20030623/NYM038)
"We're attempting to identify prostate cancer earlier and locate it more
accurately, which will result in improved long-term prognosis for patients,"
said Bruce Sodee, M.D., Professor of Radiology (NM), Case Western Reserve
University, Cleveland, OH, and a specialist in nuclear medicine at University
Hospitals of Cleveland.
Through this partnership, world-renowned physicians at the University Hospitals
of Cleveland are using the Siemens e.cam(TM) gamma camera with Flash 3D
iterative reconstruction and CT attenuation correction technology, in
combination with the monoclonal antibody agent ProstaScint(R) from Cytogen. The
resulting images are providing major improvements for the diagnosis and staging
of metastatic prostate cancer, according to Dr. Sodee.
"It is the combination of the outstanding digital imaging capabilities of the
Siemens e.cam system and the radiopharmaceutical from Cytogen that is making our
efforts so successful," said Dr. Sodee. "Specifically, the Flash 3D and CT
attenuation correction software available with the e.cam are making a clear
difference in our ability to pinpoint the exact location of tumors."
In their research at the University Hospitals of Cleveland, Dr. Sodee and his
team are imaging the prostate prior to surgery, and then confirming their
diagnosis through examination of the specimen following the procedure. He
reports they are averaging an accuracy of approximately 90 percent in the
identification of the tumor location through the imaging procedure, as verified
by pathology.
Dr. Sodee says that another step his team plans to take within the next month
will be to image patients prior to their biopsy procedure, to provide targeting
for the urologist performing the biopsy. "We will be breaking new ground in this
area - urologists typically perform biopsies 'blind' with limited guidance," he
explained.
The "last stop" in this prostate imaging research will be to improve scatter
correction in the image, which will help to quantitatively identify exactly how
much activity is in the tumor. "This achievement will help tremendously with
prostate cancer research and treatment planning," said Dr. Sodee.
"There are approximately 220,000* new cases of prostate cancer reported each
year in the United States, and this research being conducted at the University
Hospitals of Cleveland of Cleveland Hospitals holds great promise for improved
diagnosis and treatment of the disease," said Michael Reitermann, president of
Siemens Medical Solutions Nuclear Medicine Group. "This is among the first
evidence of the power of these 'smart tracers' used in combination with
state-of-the-art imaging devices. Siemens is committed to continuing to develop
medical innovations that will allow these important medial breakthroughs and
deliver proven outcomes to our customers and their patients."
"Advances in medical imaging equipment, enhanced processing technology and
hybrid imaging - all now readily accessible through Siemens innovations - link
anatomic CT images to optimized ProstaScint functional images. This information
is vital to physicians and their patients as they weigh the variety of
therapeutic options available to treat prostate cancer," said Deborah Kaminsky,
vice president business development for Cytogen. "Cytogen is pleased to announce
this partnership with industry leading innovators at Siemens and University
Hospitals of Cleveland to further the research in functional fusion imaging
directed at establishing new standards of care for prostate cancer patients."
NOTE:
ProstaScint is indicated as a diagnostic imaging agent in newly diagnosed
patients with biopsy-proven prostate cancer, thought to be clinically localized
after standard diagnostic evaluation and who are thought to be at high risk for
pelvic lymph node metastases. ProstaScint is also indicated in
post-prostatectomy patients and a negative or equivocal standard metastatic
evaluation in whom there is a high clinical suspicion of occult metastatic
disease. This press release describes clinical applications and imaging
performance that differs from that reported in the ProstaScint package insert. A
copy of the full prescribing information for ProstaScint can be found at
www.cytogen.com.
Siemens Medical Solutions of Siemens AG (NYSE: SI) with headquarters in Malvern,
Pennsylvania and Erlangen, Germany, is known for bringing together innovative
medical technologies, healthcare information systems, management consulting, and
support services, to help customers achieve tangible, sustainable, clinical and
financial outcomes. Employing approximately 31,000 people worldwide and
operating in more than 120 countries, Siemens Medical Solutions reported sales
of 7.6 billion EUR, orders of 8.4 billion EUR and group profit of 1 billion EUR
for fiscal 2002. More information can be obtained by visiting
www.siemensmedical.com.
Cytogen Corporation of Princeton, NJ is a product-driven, oncology-focused
biopharmaceutical company. Cytogen markets proprietary and licensed products
through its in-house 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 developed Quadramet(R), a skeletal targeting therapeutic
radiopharmaceutical for the relief of bone pain in prostate and other types of
cancer, marketed presently by Berlex Laboratories, the U.S. affiliate of
Schering AG Germany. Cytogen has exclusive U.S. marketing rights to Combidex(R),
an ultrasmall superparamagnetic iron oxide contrast agent for magnetic resonance
imaging of lymph nodes that is pending clearance by the FDA. For more
information, please visit the Company's website at www.cytogen.com.
University Hospitals Health System (UHHS) is the region's premier healthcare
delivery system, serving patients at more than 150 locations throughout northern
Ohio. The System's 947-bed, tertiary medical center, University Hospitals of
Cleveland (UHC), is the primary affiliate of Case Western Reserve University
(CWRU). Together, they form the largest center for biomedical research in the
State of Ohio. Included in UHC are Rainbow Babies & Children's Hospital, among
the nation's best children's hospitals; Ireland Cancer Center, northern Ohio's
only National Cancer Institute-designated Comprehensive Cancer Center (the
nation's highest designation); and MacDonald Women's Hospital, Ohio's only
hospital for women. For more information, go to www.uhhs.com.
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 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.
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, Mass., and PRINCETON, N.J., Jun 18, 2003 /PRNewswire-FirstCall via
COMTEX/ -- 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.