Navidea Biopharma Issues Highlights of Lymphoseek Data at JIOC

Navidea Biopharmaceuticals, Inc. NAVB, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced highlights of data from its Lymphoseek^® (technetium Tc 99m tilmanocept) Injection studies in patients with breast cancer, melanoma and head and neck cancer that were presented at the recent Joint International Oncology Congress (JIOC), from May 27-29, 2013. Six studies were presented, featuring new technical insights on the unique binding mechanism of Lymphoseek and comparative performance characteristics of the product in the clinical setting. “Data from a pilot study of Lymphoseek, taken together with the key benefits of the product that were highlighted at JIOC this week, further demonstrate how Lymphoseek is a promising precision diagnostic, delivering benefit for patients and physicians,” said Frederick O. Cope, Ph.D., Senior Vice President and Chief Scientific Officer at Navidea Biopharmaceuticals. “We believe that as physicians understand how Lymphoseek was purposely designed to function at the molecular level, that they will appreciate the utility that precision receptor targeting brings to the clinical setting for lymphatic mapping. We look forward to continued advances with Lymphoseek and providing additional results from future investigator-initiated studies as they become available.” Three presentations detailed the mechanism through which tilmanocept selectively targets and tightly binds to receptors found in lymph nodes. Dr. Larry Schlesinger and colleagues described the CD206-specific binding properties of tilmanocept, noting that tilmanocept accumulation in tumor-positive sentinel lymph nodes in head and neck cancer was even greater than what was observed in tumor-negative sentinel nodes. Sentinel lymph nodes that were tumor-positive recruited significant numbers of dendritic cells compared to tumor-negative sentinel lymph nodes and non-sentinel lymph nodes, resulting in a 10-fold increase in tilmanocept uptake in tumor-positive nodes than in nodes that were tumor-negative. Comparative clinical performance characteristics of tilmanocept against those of non-receptor targeted colloidal materials used in the United States and Europe were also highlighted at the Congress. Dr. Alice Chung and colleagues presented data from a meta-analysis of tilmanocept results and a comprehensive literature review of European practice in sentinel lymph node mapping. The data demonstrated a statistical performance difference between tilmanocept and European colloidal materials in breast cancer patients. An initial pilot study conducted by Dr. Nathan Hall and colleagues examined the uptake and injection site clearance time of tilmanocept and 99m technetium sulfur colloid in breast cancer patients using dynamic SPECT/CT. The Co-chairs of The Joint International Oncology Congress made a joint comment relating to presentations made at the Congress: “The international faculty and experts attending this year's JIOC found the sessions on recent advances in targeted agents for lymphatic mapping and sentinel lymph node biopsy both educational and stimulating for scientific discussion. Attendees were interested to learn more about how tilmanocept functions at the molecular level and to be updated on its clinical performance. Part of our mission for JIOC is to help expand understanding and practices of clinical oncologists and to bring the clinical relevance of cancer metastasis to basic scientists, and sessions such as these help us meet that goal,” said Armando E. Giuliano, MD, FDACS, FRCSEd, President, International Sentinel Node Society and Executive Vice Chair of Surgery, Surgical Oncology, Department of Surgery and Associate Director, Surgical Oncology, Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center in Los Angeles, CA; and Stanley P. L. Leong, MD, FACS, President, Sentinel Node Oncology Foundation and Head of Melanoma Surgery and Chief of Cutaneous Surgery at the California Pacific Medical Center and Research Institute in San Francisco. Full content of all JIOC abstracts may be found at: http://www.sn-cancermets.org/docs/caa.pdf.