Navidea Biopharmaceuticals Announces Presentation of Lymphoseek® Phase 3 Data at Society of Surgical Oncology Meeting

Navidea Biopharmaceuticals, Inc.

today announced that data from its Phase 3 clinical study investigating 99m-Tc-Tilmanocept (Lymphoseek®) in oral and squamous cell cancers were presented as a poster presentation at the 65th Annual Cancer Symposium of the Society of Surgical Oncology meeting held in Orlando, Florida, March 21-24, 2012. The data presented by investigator Stephen Y. Lai, M.D., Ph.D., FACS, of the University of Texas MD Anderson Cancer Center, describe the Center's initial experience with Lymphoseek in Sentinel Lymph Node mapping in nine patients with head and neck SCC. Frederick O. Cope, Ph.D., FACN, Navidea's Senior Vice President of Pharmaceutical Research and Clinical Development commented, “These data comprise the first presentation of Lymphoseek's potential utility in oral cancers. The presentation by Dr. Lai suggests that Lymphoseek's previously reported ability to accurately facilitate identification of primary draining nodes necessary to properly stage patients with breast cancer or melanoma may also apply in patients with HNSCC. We believe this is due to Lymphoseek's rapid transit through lymphatic vessels and targeted binding to the mannose binding receptors (

) within key predictive nodes. The results in these nine patients demonstrated a false negative rate of zero, the same as obtained with full nodal dissection. However, using Lymphoseek, substantially fewer lymph nodes are removed than with full nodal dissection. This may enable surgeons to reduce the need for more extensive lymph node dissection, potentially sparing them from the morbidity and side effects of full nodal dissection while not sacrificing accuracy in the detection of key predictive lymph nodes identified by more aggressive full regional dissection.”