To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: RSNA: Comidex Contrast Agent Distinguishes Malignant From Normal Lymph Nodes URL: http://www.pslgroup.com/dg/20F32A.htm Doctor's Guide December 4, 2001
PRINCETON, NJ and CAMBRIDGE, MA -- December 4, 2001 -- Cytogen Corporation and Advanced Magnetics, Inc. announced today that at the Radiological Society of North America, Inc.'s 87th Scientific Assembly and Annual Meeting in Chicago, Illinois, radiologists reported that Combidex®, an investigational magnetic resonance imaging (MRI) contrast agent, is able to distinguish malignant from normal lymph nodes in the majority of prostate cancer patients. In the presentation, data on 44 patients with confirmed prostate cancer was reported by Mukesh Harisinghani, M.D., assistant radiologist with Massachusetts General Hospital and instructor of radiology at Harvard Medical School. Lymph nodes were evaluated using MRI before and after the administration of Combidex and later compared to pathology results following surgery. When qualitative image evaluation results were compared to histopathologic analysis, Combidex was able to detect malignant lymph nodes with 93 percent specificity and 92 percent sensitivity, reflecting a very high level of correlation. "Lymph nodes are often the first sites to which cancer spreads from the primary tumor. Before Combidex, there were no non-invasive methods available to accurately identify lymph nodes invaded by metastatic disease. Combidex provides important staging information that is critical to making the best treatment decisions for prostate and other cancers," said H. Joseph Reiser, Ph.D., Cytogen's president and chief executive officer. Following a priority review, Combidex received an approvable letter from the U.S. Food and Drug Administration (FDA) in June 2000. "This latest study is further evidence that Combidex can provide critical information regarding the detection of metastatic cancer, representing a major advance in cancer detection and staging," said Jerome Goldstein, chairman and chief executive officer of Advanced Magnetics. "We are continuing discussions with the Food and Drug Administration to advance this important product towards final approval." In August 2000, Cytogen and Advanced Magnetics entered into marketing, license and supply agreements for Combidex and for Code 7228, another MRI contrast agent. Cytogen has exclusive U.S. rights to Combidex for the detection of lymph node metastases and exclusive U.S. rights to Code 7228 for oncology applications. Advanced Magnetics is responsible for all costs associated with clinical development, supply and manufacture of Combidex and Code 7228. In addition to payment for supplying Cytogen with finished product, Advanced Magnetics will receive royalties based upon product sales. Cytogen and Advanced Magnetics have established project teams to cooperate on the development of Combidex. 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 estimates that nearly 200,000 new cases of prostate cancer will be diagnosed this year in the U.S., and that 31,500 men will die of the disease. SOURCE: Cytogen Corporation and Advanced Magnetics, Inc --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.