“This study is part of Navidea’s strategy to expand the utilization of Lymphoseek into multiple cancer types to assist physicians and patients in improving the accuracy of cancer diagnosis and staging,” said Thom Tulip, Ph.D., Executive Vice President and Chief Business Officer. “We believe that Lymphoseek fills an important unmet need as an ideal agent to enable lymphatic mapping in cancers where the procedure may be highly useful, but for which a suitable agent has not yet been developed. Lymphoseek targets key predictive lymph nodes through its specifically-designed, receptor-based mechanism, which we believe can enhance diagnostic accuracy through rapid injection site clearance, stable target binding, and fewer false negative results. We believe these characteristics can enable more accurate staging of cancer in patients undergoing lymphatic mapping procedures, while affording scheduling flexibility.”

About the Lymphoseek NEO3-06 Trial

Navidea’s NEO3-06 clinical trial is an open-label, multicenter study of Lymphoseek® (technetium Tc 99m tilmanocept) Injection. The study is designed to identify Sentinel Lymph Nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. This study is a supplement to the previously conducted Phase 3 trials of Lymphoseek in breast cancer and melanoma designed to establish Lymphoseek as an effective radiopharmaceutical agent to be used in the intraoperative localization of lymph nodes in the lymphatic pathway draining the primary site of a tumor which have the highest probability of harboring cancer.

About Lymphoseek ®

Lymphoseek ® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancers such as 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.

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, 76,000 new cases of melanoma and 67,000 new cases of head and neck cancers are expected to be diagnosed in the United States in 2012.

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