Lymphoseek (Navidea) success in Head and Neck cancer trial

Navidea Biopharmaceuticals, Inc. announced top-line results from the interim analysis of its Phase III clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma. Results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma of the head or in the mouth, as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Multiple level nodal dissection surgery is considered the �gold standard� to determine the presence and extent of cancer spread in lymph nodes of patients with head and neck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.