Navidea Biopharmaceuticals Release: Results of Lymphoseek® Phase 3 Clinical Trials in Melanoma Published in Annals of Surgical Oncology
Published: Oct 09, 2012
DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with melanoma of the skin. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping. Results demonstrated that Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with VBD. Lymphoseek is a receptor-targeted radiopharmaceutical under development for use in lymphatic mapping, a procedure in which key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes. The study, “Combined Analysis of Phase III Trials Evaluating [99mTc]Tilmanocept and Vital Blue Dye for Identification of Sentinel Lymph Nodes in Clinically Node-Negative Cutaneous Melanoma,” was published in the current online edition of the journal Annals of Surgical Oncology [DOI 10.1245/s10434-012-2612-z].