Navidea Biopharmaceuticals is highlighting results from a phase III clinical trial of its Lymphoseek radiopharmaceutical.
The study, which was presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in St. Louis, showed that the agent accurately targets appropriate lymph nodes, according to the firm.
Eighty-three patients were evaluated to determine whether Lymphoseek localization in pathology-positive lymph nodes was higher than its localization in pathology-negative nodes, and if those results were consistent with the overall sentinel lymph-node population, Navidea said.
Sentinel lymph nodes and/or nonsentinel lymph nodes were removed from patients undergoing sentinel lymph-node biopsy for head and neck squamous cell carcinoma, and all lymph nodes were assessed for the presence of tumor.
Average in-vivo gamma counts for all lymph nodes removed showed that the count ratio of pathology-positive nodes to pathology-negative nodes was approximately 18:1 (p < 0.0001), the company said.
