CAMBRIDGE, Mass., and PRINCETON, N.J., Oct. 22 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. and Cytogen Corporation today announced that an article published in the November 2004 issue of Radiology reports that magnetic resonance imaging (MRI) in conjunction with COMBIDEX(R) (ferumoxtran-10), an investigational molecular imaging agent to aid in the non-invasive diagnosis of metastatic lymph nodes, improves the sensitivity for detecting the spread of cancer to lymph nodes in patients with urinary bladder cancer. COMBIDEX was shown to improve the ability to detect lymph node metastases, particularly in normal-sized nodes. The article contains the results of a clinical research study conducted by radiologists at the University Medical Center Sint Radboud, the Netherlands; Charite Hospital, Berlin; and Massachusetts General Hospital, Boston. Overall, 172 lymph nodes from 58 bladder cancer patients were evaluated by MRI both prior to and after the administration of COMBIDEX. The imaging results were then compared to the pathology findings following surgical removal of the nodes.
In patients presenting with bladder cancer, one of the most common malignancies of the urinary tract, prognosis depends on the depth of penetration of the primary tumor into the bladder wall and the extent of the spread of cancer to the lymph nodes. Because of the prominent role of these factors, physicians must accurately assess the extent of the involvement of the nodes in order to determine the optimal sequence of surgical and systemic treatments. The data in the Radiology article revealed that current anatomic imaging techniques which rely on insensitive size criteria correctly identified the presence of cancer in lymph nodes 76% of the time. Following the administration of COMBIDEX, the sensitivity for detection of cancer in the same lymph nodes was increased to 96%. As described in the Radiology article, normal and cancerous nodal tissues have different signal intensities on COMBIDEX-enhanced MRI. This difference allows detection of metastases even in normal-sized nodes.
"The bladder cancer study results published in Radiology are consistent with previously reported results in the New England Journal of Medicine of a prostate cancer study where MRI with COMBIDEX improved the accuracy of characterizing lymph nodes," stated Jerome Goldstein, Chairman and Chief Executive Officer of Advanced Magnetics. "This data continues to support our belief that COMBIDEX could assist physicians in the non-invasive diagnosis of metastatic lymph nodes. We are very pleased with these results."
COMBIDEX received an approvable letter, subject to certain conditions, from the U.S. Food and Drug Administration (FDA) for use in the diagnosis of metastatic lymph nodes. Advanced Magnetics has submitted a complete response to the approvable letter that was accepted by the FDA and assigned a user fee goal date of March 30, 2005. Cytogen has exclusive rights in the United States to market COMBIDEX.
About Advanced Magnetics
Advanced Magnetics, Inc. is a 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 biopharmaceutical company that develops and commercializes innovative molecules that can be used to build franchises across multiple markets. 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) for all indications. COMBIDEX, an investigational molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and 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: (1) the possibility that even though Advanced Magnetics' response was 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; (2) the ability to resolve final labeling for COMBIDEX with the FDA; (3) the possibility that even though the FDA has assigned a user fee goal date of March 30, 2005, the FDA may not act by such date; (4) uncertainties regarding market acceptance of COMBIDEX; (5)the possibility that COMBIDEX may not be as effective in improving lymph node characterizations as studies have shown or that the results of past studies may not be replicated in future studies; (6) uncertainties relating to third-party reimbursements to Advanced Magnetics or its partners for COMBIDEX when patients are prescribed treatment with COMBIDEX; (7) uncertainties relating to Advanced Magnetics' ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing COMBIDEX; 87) uncertainties relating to patents and proprietary rights and other risks identified in Advanced Magnetics' 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.
Advanced Magnetics, Inc.; Cytogen Corporation