Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the presentation of additional results from its pivotal Phase 3 clinical trial (NEO3-06) for Lymphoseek ® (technetium Tc 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma. Navidea previously announced that the NEO3-06 study met the primary false negative rate 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. This 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. The now completed full study report indicates that Lymphoseek also met all other pre-specified study endpoints, including sensitivity, negative predictive value and overall accuracy relative to the pathology status of non-SLNs. No differences were observed in the ability of Lymphoseek to detect SLNs between same-day or subsequent-day surgery following Lymphoseek injection. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved by the U.S. Food and Drug Administration for use in lymphatic mapping to assist in the localization of lymph nodes draining primary tumor in patients with breast cancer or melanoma. The results were presented at the American College of Surgeons 2013 Annual Clinical Congress by Amit Agrawal, MD, Associate Professor, The Ohio State University College of Medicine, Department of Otolaryngology – Head and Neck Surgery, a lead investigator on the NEO3-06 Phase 3 clinical trial.
“Thousands of patients with head and neck cancer stand to benefit from accurate diagnostic evaluation of their condition, and we are pleased that the final results for Lymphoseek from our NEO3-06 Phase 3 clinical trial are being presented to surgeons attending the prestigious American College of Surgeons Clinical Congress,” said Mark Pykett, VMD, PhD, Chief Executive Officer of Navidea. “The NEO3-06 trial is representative of Navidea’s global strategy to expand Lymphoseek utilization into multiple cancer types with the aim of assisting physicians in improving accuracy and evaluating the extent of disease. As previously announced, we closed the NEO3-06 trial at the recommendation of the Data Safety Monitoring Committee. Based on study results and data analysis and dialogue with the U.S. Food and Drug Administration (FDA), we are working to file an sNDA for Lymphoseek with the FDA by the end of this year and anticipate EMA action related to the EU MAA for Lymphoseek also by year end.”