Advanced Magnetics Inc and Cytogen Corporation announced the publication of clinical data showing that magnetic resonance (MR) imaging with Combidex, an ultrasmall superparamagnetic iron oxide contrast agent, is effective for the preoperative assessment and staging of axillary lymph nodes in patients with breast cancer.The results from a recent study were reported in the November 2002 issue of the journal Radiology.

The study by researchers in Europe involved 18 patients with breast cancer, all of whom were scheduled for surgery.The researchers performed MR imaging of the breast and axillary lymph nodes within 24 to 36 hours after the administration of Combidex. When imaging evaluation results were compared to histopathologic analysis, results of axillary lymph node staging with Combidex resulted in a sensitivity of 82%, specificity of 100%, and a positive predictive value of 100%.

"Treatment strategy in patients with breast cancer is dependent not only on the extent of the primary tumor but also on axillary lymph node staging," said H. Joseph Reiser, president and chief executive officer of Cytogen Corporation. "We believe that Combidex can play an important role in the staging of metastatic disease in a variety of cancers, especially through providing additional information in the determination of lymph node status.This information is key to allowing cancer patients and their physicians to make more appropriate treatment decisions."

Computed tomography (CT) and MR imaging are the methods currently used for imaging lymph nodes.Without contrast agents, CT and MR imaging cannot distinguish between lymph nodes that are enlarged due to the infiltration of cancerous cells as opposed to inflammation.Previous published findings in patients with head and neck, urologic, and pelvic cancers have confirmed the potential for improved detection of lymph node metastases by using Combidex-enhanced imaging when compared to non-enhanced or gadolinium-enhanced MR imaging.

"We are very encouraged by the results from this new study," stated Jerome Goldstein, chairman and chief executive officer of Advanced Magnetics. "We continue to work with the U.S. Food and Drug Administration (FDA) to resolve the outstanding issues from the approvable letter received from the FDA for Combidex and remain hopeful that we will be successful in this effort."

Combidex, the lead product in Advanced Magnetics' development pipeline, received an approvable letter, subject to certain conditions, from the FDA in June 2000 for use in the diagnosis of lymph node disease. Cytogen Corporation has exclusive U.S. marketing rights to Combidex.

Breast cancer is the most common cancer among women. It is the second leading cause of cancer death in women, after lung cancer.In 2002, the American Cancer Society estimates that 203,500 new invasive cases of breast cancer are expected to occur among women in the United States, and an estimated 39,600 deaths are anticipated from the disease.