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Presentations at ISMRM Suggest Combidex(R) Useful in Detecting

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howardjoel   Tuesday, 08/24/04 07:40:54 AM
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Presentations at ISMRM Suggest Combidex(R) Useful in Detecting the Spread of Breast and Prostate Cancers to Lymph Nodes
CAMBRIDGE, Mass., and PRINCETON, N.J., July 15 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. (Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) today announced data showing that magnetic resonance imaging (MRI) with Combidex(R) (ferumoxtran-10), an investigational iron oxide nanoparticle, aids in the non-invasive diagnosis of metastatic lymph nodes. The data presented at the International Society for Magnetic Resonance in Medicine (ISMRM) 11th Scientific Meeting held in Toronto, July 10-16, 2003 was from a study that included patients with breast and prostate cancer.

One presentation entitled "Detection of Minimal Nodal Disease in Patients with Breast Cancer," was made by Dr. Mukesh Harisinghani, Assistant Radiologist at Massachusetts General Hospital. Dr. Harisinghani concluded that Combidex-enhanced MRI is a useful tool for characterizing lymph nodes in patients with breast cancer. Dr. Harisinghani also noted that one of the patients analyzed in this presentation was determined to be free of metastatic disease based on sentinel node mapping and biopsy of the sentinel node but that another lymph node was determined to be metastatic based on Combidex-enhanced imaging. This second node was confirmed to be metastatic after removal at surgery.

A second presentation on data from prostate cancer patients was made by Dr. Ralph Weissleder, Director of the Center for Molecular Imaging Research at Massachusetts General Hospital. Dr. Weissleder concluded that Combidex is a useful MRI contrast agent for characterizing lymph nodes in patients with prostate cancer, and that Combidex-enhanced images alone may suffice for lymph node characterization.

"The data presented here show the potential role that Combidex-enhanced imaging could have in the diagnosis of lymph node metastases," stated Jerome Goldstein, Chairman and Chief Executive Officer of Advanced Magnetics. "The results coming from Dr. Harisinghani's group at Massachusetts General Hospital have consistently shown the advantages that Combidex could have in assisting physicians in staging cancer patients. We continue to be encouraged by these results."

"Both of the presentations made at ISMRM build on 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 supports our belief that Combidex could be an important new tool for physicians and their patients in staging a variety of cancers."

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.




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