Positive Ph III results for Navidea's Lymphoseek in head and neck cancer

US biotech firm Navidea Biopharmaceuticals (NYSE:NAVB) today announced positive peer-reviewed publication of results from a Phase III clinical trial of Lymphoseek (technetium 99m tilmanocept) injection in patients with certain head and neck cancer (squamous cell carcinoma of the oral cavity, NEO3-06; NCT00911326) in the journal Annals of Surgical Oncology.

Lymphoseekinjection is the first and only US Food and drug Administration-approved receptor-targeted lymphatic mapping agent.

The trial assessed the performance of Lymphoseek-guided sentinel node biopsy against the standard of care, nodal pathology, in planned elective neck dissection (END). Results demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with node-negative squamous cell carcinoma of the oral cavity, as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Pathology assessment of lymph nodes from the multiple level nodal dissection surgery is considered the “gold standard” to determine the presence and extent of cancer spread.