Data from phase III study of Combidex published.

2003 OCT 2 - (NewsRx.com & NewsRx.net) -- Advanced Magnetics, Inc., (AVM) and Cytogen Corporation (CYTO) announced that data from the phase III clinical study of Combidex (ferumoxtran-10) in lymph nodes were 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 CEO 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 ...