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Investigational New Drug Combidex (Ferumoxtran-10) Useful In Detecting The Spread Of Cancer To Lymph Nodes CAMBRIDGE, MA and PRINCETON, NJ -- September 4, 2003 -- Advanced Magnetics, Inc. (Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) today announced that data from the phase III clinical study of Combidex® (ferumoxtran-10) in lymph nodes was published in the September issue of the journal Radiology. The data showed that magnetic resonance (MR) imaging with Combidex, an investigational superparamagnetic iron oxide nanoparticle, aids in the non-invasive evaluation of metastatic lymph nodes in patients with head and neck, chest, breast, abdominal, and pelvic cancers. Researchers concluded that the use of "[Combidex]-enhanced MR imaging was safe and effective and facilitated improved diagnostic performance." "We are pleased to see the continued publication of data in peer-reviewed publications which show the advantages of Combidex-enhanced MR imaging over current practice," stated Jerome Goldstein, Chairman and Chief Executive Officer of Advanced Magnetics. "This kind of publication reinforces our opinion that Combidex would be a significant advance in the diagnosis of metastatic cancer in lymph nodes." This study included 147 patients with primary malignancies who were suspected of having nodal metastases of which 29 had head and neck cancer, 32 had lung or mediastinal cancer, 23 had breast cancer, 25 had abdominal cancer, 38 had pelvic cancer, and two patients had both abdominal and pelvic cancers. For each patient, MR imaging was performed before the administration of Combidex and 24-36 hours after Combidex administration. The MR imaging results were correlated with pathology. No serious adverse events were reported. Overall the data demonstrated that Combidex-enhanced MR imaging improved diagnostic accuracy from 68% to 85% as compared to MR imaging prior to the administration of Combidex. "The publication of this study builds upon the data we have seen for Combidex in a number of cancers that spread to the lymph nodes," said Michael Becker, President and Chief Executive Officer of Cytogen Corporation, which has exclusive U.S. marketing rights to Combidex. "This growing body of scientific data, including data published in other scientific publications like the New England Journal of Medicine, supports our belief that Combidex could be an important new tool for physicians and their patients in evaluating the spread of many cancers to lymph nodes." Many cancers spread via the lymphatic system, such as breast, lung, colorectal, prostate, ovarian, bladder, melanoma, and uterine cervical cancers. The American Cancer Society estimates that there will be over 900,000 new cases of these types of cancer diagnosed in 2003. 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 millimeters in size are usually deemed cancerous while nodes less than 10 millimeters in size are generally presumed normal. 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 MR imaging. 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 metastatic lymph nodes. 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. SOURCE: Advanced Magnetics, Inc. E-mail this page to a friend or colleague! To print, use this version