Navidea Biopharmaceuticals, Inc. (NYSE:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that results from the Phase 3 clinical trial of Lymphoseek ® (technetium Tc 99m tilmanocept) Injection in Head and Neck Cancer (NEO3-06) at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute were published in the current edition of the peer-reviewed journal, JAMA Otolaryngology Head and Neck Surgery, a publication of the American Medical Association.
The publication, “Use of a Novel Receptor-Targeted (CD206) Radiotracer, 99m-Tc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral Cavity Squamous Cell Carcinoma: Initial Institutional Report in an Ongoing Phase 3 Study,” describes the experience at one of the clinical trial sites that participated in NE03-06, a Phase 3 study designed to assess the potential utility of Lymphoseek as a sentinel lymph node mapping agent in patients with head and neck cancer.
“The results, published independently by this single clinical trial site in our larger Phase 3 NE03-06 study, corroborate data for the ability of Lymphoseek to identify sentinel lymph nodes in head and neck squamous cell carcinoma,” said Mark Pykett, VMD, PhD, CEO of Navidea. “As Navidea previously announced, Lymphoseek met the primary endpoint in the NE03-06 trial, where it correctly identified pathology-positive lymph nodes in 38 of 39 patients, demonstrating a statistically significant overall False Negative Rate of 2.56 percent. We look forward to additional presentations of the broader dataset from our NE03-06 Phase 3 clinical trial in the coming months. We have closed the study following a constructive FDA meeting and with the recommendation of the Data Safety Monitoring Committee. Based on the NEO3-06 study results and data analysis, we are working to file an sNDA for Lymphoseek by year end.”
About Lymphoseek ®Lymphoseek ® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with 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. 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. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others. Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013.