Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today provided updates on several programs and events relating to Lymphoseek ® (technetium Tc 99m tilmanocept) Injection, including a head-to-head clinical study underway at the University of California, San Diego (UCSD). The UCSD study is comparing the level of discomfort experienced by breast cancer patients after injection of Lymphoseek or radiolabeled sulfur colloid in lymphatic mapping procedures. Navidea also highlighted updates on the European filing for Lymphoseek with the Marketing Authorization Application (MAA) and multiple upcoming medical and scientific presentations. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved by the U.S. Food and Drug Administration for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.
Head-to-Head Clinical Study Comparing Injection Pain Associated with Radiolabeled Sulfur Colloid vs. Lymphoseek
The investigator-initiated study underway at UCSD marks the first prospective, randomized, double-blinded controlled clinical study to address the issue of injection site pain between two radiopharmaceuticals that are commonly used in lymphatic mapping procedures. It is designed to determine if patients receiving Lymphoseek experience the same or less pain following injection compared to radiolabeled sulfur colloid, and to measure the amount of discomfort that patients report during and after injection. The study is also exploring comparative performance characteristics such as amount of time to sentinel lymph node visualization on lymphoscintigraphy imaging prior to surgery, sentinel lymph node localization success and the number of tumor draining lymph nodes removed.
“Surgeons who perform sentinel lymph node biopsy procedures in breast cancer and melanoma patients focus not only on clinical outcomes, but on optimizing the patient’s overall experience during a vulnerable time,” said Anne Wallace, M.D., Professor of Surgery, UC San Diego School of Medicine; Director of the Comprehensive Breast Health Center; UC San Diego Moores Cancer Center, and Principal Investigator on the study. “It is well accepted that sentinel node injection can be painful. We designed this study to try to understand if Lymphoseek injection is less painful and could improve the patient experience.”