Neoprobe Corporation (NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that results from a Phase II study of Lymphoseek® (Tilmanocept) have been published online in the Annals of Surgical Oncology and demonstrate the tracing agent’s ability to identify tumor-draining lymph nodes in breast cancer and melanoma patients. The publication of the multi-center clinical results was announced yesterday after market close by Dr. Stanley Leong, Chief of Cutaneous Oncology and Associate Director of the Melanoma Program at the Center for Melanoma Research and Treatment, California Pacific Medical Center. Dr. Leong was the lead author of the study.
“These data add to the wealth of knowledge on Lymphoseek and are encouraging as we prepare for the submission of the Lymphoseek NDA in the coming months.”
“The data published in the surgical oncology community’s leading peer-reviewed journal further validates the clinical importance and potential utility of Lymphoseek in improving diagnosis of melanoma and breast cancer,” said Dr. Frederick O. Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development, of Neoprobe. “These data add to the wealth of knowledge on Lymphoseek and are encouraging as we prepare for the submission of the Lymphoseek NDA in the coming months.”
According to the American Cancer Society, approximately 209,000 new cases of breast cancer and 68,000 new cases of melanoma were diagnosed in the United States in 2010. Sentinel lymph node (SLN) mapping is a widely adopted intraoperative procedure for the identification of lymph nodes draining the pathway from a primary tumor. Despite widespread use of tracing agents, including vital blue dyes and 99mTc-labeled sulfur colloid, none of these compounds are FDA-approved for use in SLN mapping procedures.