Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its completed Phase 3 Lymphoseek studies in breast cancer and melanoma are being presented at the 32 Congress of the European Society of Surgical Oncology (ESSO) in Valencia, Spain, from September 19-21, 2012. During the session, Frederick Cope, Ph.D., Navidea’s Senior Vice President of Pharmaceutical Research and Drug Development, will make an oral presentation of a meta-analysis comparison of data from Lymphoseek Phase 3 breast cancer studies and a meta-analysis of published literature on three colloidal agentsevaluating two key clinical performance characteristics in intraoperative lymphatic mapping. In addition, Dr. Cope will present a poster of the results from combined Phase 3 clinical trials in breast cancer and melanoma demonstrating a positive correlation between preoperative imaging (lymphoscintigraphy) using Lymphoseek and the intraoperative/surgical findings of tumor-draining lymph nodes.
“We are extremely pleased with the opportunity to present these results from our Lymphoseek Phase 3 trials to this important European medical audience,” said Mark Pykett, Ph.D., President and CEO of Navidea. “We remain on plan to submit our Marketing Authorization Application (MAA) in the European Union by the end this year and believe that Lymphoseek can address a significant medical need for those with solid tumor cancers in Europe.”
Lymphoseek(technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, in patients with breast cancer or melanoma.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 229,000 new cases of breast cancer and 76,000 new cases of melanoma are expected to be diagnosed in the United States in 2012.
Lymphatic mapping is a procedure designed to guide lymph node dissection and biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide guidance on the location of lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. These nodes, commonly referred to as “Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant cells. Lymphatic Mapping provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is actively developing four radiopharmaceutical agent platforms – Lymphoseek, NAV4694, CFT and RIGScan – to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and, ultimately, patient care. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and advancing the Company’s pipeline through selective acquisitions, global partnering and commercialization efforts. For more information, please visit .