Navidea presents Phase 3 Lymphoseek study results at international symposium in Athens

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that a presentation of results from its Phase 3 clinical trial of Lymphoseek^® (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma received the 1^st Investigator Award at the 2^nd InternationaI Symposium on Thoracic and Upper Aerodigestive Malignancies. The symposium was held April 4-6, 2013 in Athens, Greece. The presentation of recently announced top-line interim results for the Phase 3 Lymphoseek study and a summary of results from three of the study's highest-accruing clinical trial sites were made by Dr. Michael Blue, MD, Senior Medical Director of Navidea Biopharmaceuticals, one of the authors.

“timing of 99mTc-tilmanocept injection resulted in no difference in regards to pathology findings”

Poster Title:

The CD206-Targeted, Molecular Sentinel Node Mapping Agent Tc99m-Tilmanocept Accurately Stages Head/Neck Squamous Cell Carcinomas (HNSCC): Prospective Interim Analysis Results From a Phase-3 Multi-Institutional Study.

Authors:

Frank Civantos, MD, FACS, University of Miami; Stephen Y. Lai, MD PhD, FACS, The M.D. Anderson Cancer Center; Amit Agrawal, MD, FACS, Ohio State University Wexner Medical Center; Douglas B. Chepeha, MD, MSP, University of Michigan; Kevin T. Brumund, MD, FACS, UCSD Medical Center; and Frederick O. Cope, PhD, Michael Blue, Wendy Metz, PhD, Bonnie C. Abbruzzese, MS, CCRA, Navidea.

The results presented by Dr. Blue et al included a summary of the pre-planned statistical interim analysis of the primary endpoint on the entire study, as recently announced by Navidea. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (that is, lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Thirty-nine subjects were determined to have pathology-positive lymph nodes and were included in the interim analysis. Results from these 39 subjects demonstrated that Lymphoseek accurately identified 38, for an overall False Negative Rate (FNR) of 2.56%.

In addition, the authors reviewed a preliminary evaluation of the NEO3-06 trial data from three of the highest-accruing clinical sites. A total of 50 subjects were evaluated from these sites; 21 had pathology-positive lymph nodes. Results indicated that Lymphoseek identified these pathology-positive lymph nodes in 21 out of 21 subjects for an FNR of 0%. The total patient population included subjects with tongue tumors, floor of mouth tumors and other intraoral head and neck tumors. The authors concluded: "^99mTc-tilmanocept demonstrated that the SLN status was highly predictive and consistent with the status of the neck for clinical stage and tumor location." They also noted that "timing of ^99mTc-tilmanocept injection resulted in no difference in regards to pathology findings," in study subjects who had same day surgery versus next day surgery.

Navidea's Phase 3 clinical trial (NEO3-06) is a prospective, open-label, multicenter, within-patient study of Lymphoseek^® (technetium Tc 99m tilmanocept) Injection. It is designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma.

The NEO3-06 study is a supplement to previously conducted Phase 3 trials of Lymphoseek in breast cancer and melanoma that were designed to establish Lymphoseek as an effective radiopharmaceutical agent for use in lymphatic mapping procedures to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Those studies formed the basis of the NDA registration package upon which the U.S. Food and Drug Administration based its U.S. approval of Lymphoseek in March, 2013. Navidea is conducting the NEO3-06 clinical study to provide evidence of Lymphoseek performance in a third cancer type and to potentially expand its product label.