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"Combidex (ferumoxtran-10) is an investigational molecular imaging agent

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howardjoel   Tuesday, 08/24/04 07:31:37 AM
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"Combidex (ferumoxtran-10) is an investigational molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from non-cancerous lymph nodes. Lymph nodes are frequently the site for metastases of many different types of cancer, particularly breast cancer and prostate cancer. Computed tomography (CT) and MRI 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. CT and MRI 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. Clinical studies have shown that Combidex accumulates in non-cancerous lymph node tissue which could enable doctors using MRI to have improved diagnostic confidence in differentiating between normal and diseased lymph nodes.

In the United States, an approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. In June 2004, we announced that a response to the approvable letter was submitted to the FDA and that the FDA requested that we provide certain additional details underlying the existing supporting data in the submission in order to make the submission a complete response to the approvable letter."





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