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 breast cancer. 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. The study, “Comparative Evaluation of [ 99m Tc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials,” was published in the current online edition of the journal Annals of Surgical Oncology [DOI 10.1245/s10434-013-2887-8].
Lymphoseek is a receptor-targeted radiopharmaceutical recently approved by the U.S. Food and Drug Administration and indicated for use in lymphatic mapping for breast cancer and melanoma. In this procedure 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.
“Lymphoseek was specifically designed to provide clinicians who perform lymphatic mapping procedures with actionable information, and we believe that the data reported in this publication demonstrate its utility and safety in identifying tumor-draining lymph nodes,” said Frederick Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development of Navidea. “These data from breast cancer patients, in conjunction with previously published data from our Phase 3 clinical trials in melanoma, comprise part of our NDA registration package for Lymphoseek with the FDA. We are confident that Lymphoseek may hold significant improvement for patients who undergo lymphatic mapping procedures.”
“Tilmanocept was originally developed at UCSD as a targeted molecular approach to help stage breast cancer and melanoma patients, and we advanced the agent through Phase 1 clinical trials with funding provided by Susan G. Komen Breast Cancer Foundation and the American Cancer Society," said Anne Wallace, M.D., Chief, Division of Plastic Surgery; Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and a Principal Investigator in the Lymphoseek Phase 3 clinical trials. “The results from these Phase 3 clinical trials in breast cancer demonstrate the potential that specifically-designed imaging agents may have an important role in reliably localizing tumor-draining lymph nodes and in optimizing patient management post-surgery. Appropriate lymphatic mapping and sentinel node biopsy can benefit certain patients by sparing them removal of unnecessary lymphoid tissue and preventing side effects such as lymphedema or swelling, pain and sensory changes, scarring or disfigurement, and extended recovery times.”