NAVB,
Navidea Biopharmaceuticals Reaches Interim Analysis Point of Phase 3 Head and Neck Cancer Study of Lymphoseek(R)
Last update: 1/3/2013 9:00:05 AM
Company to conduct planned interim analysis of available clinical data
DUBLIN, Ohio, Jan 03, 2013 (BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (nyse mkt:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals today announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the Company to conduct a pre-planned interim analysis. This Phase 3 trial of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection, a novel intraoperative lymphatic mapping (ILM) agent, is designed to demonstrate the performance of Lymphoseek in identifying sentinel lymph nodes in subjects with squamous cell carcinoma on the head or in the mouth. The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck. This full dissection surgery is considered the gold standard for determining the presence and extent of cancer and staging of the disease in such patients. A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort. Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013.
"We believe this study is unique because it compares Lymphoseek's performance to a pathological 'truth standard' obtained from a head and neck cancer procedure in which the entire regional lymph node population is removed," commented Fred Cope, Ph.D., Navidea's Senior Vice President of Pharmaceutical Research and Drug Development. "In 2012, positive data from three sites participating in this study were presented at medical meetings by independent investigators characterizing the performance of Lymphoseek at their individual study centers in identifying sentinel lymph nodes in head and neck squamous cell carcinoma. The results appeared very promising. These investigators reported that, for patients accrued up to that date, Lymphoseek had a 0% false negative rate and was 100% predictive of the pathological status of the patient."
Dr. Cope added, "In head and neck cancer it is not uncommon to remove 40, 50, or even 100 regional lymph nodes during full dissection surgery, which can result in substantial and long-term morbidity for patients. An effective sentinel lymph node mapping agent could markedly limit the number of lymph nodes required to conduct pathological assessment and determine whether the cancer has spread. We believe that the NEO03-06 study may provide additional data to demonstrate Lymphoseek's usefulness in characterizing this important type of cancer, and potentially support its use as a sentinel lymph node mapping agent that can facilitate accurate cancer staging and decrease the extent of surgery for some patients, thereby reducing possible serious morbidity."
"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(R) (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.
