Navidea’s Presentation of Top-Line Interim Analysis of Lymphoseek ^® Head and Neck Phase 3 Trial Selected for Investigator Award

– Data presented at the 2 ^nd International Symposium on Thoracic and Upper Aerodigestive Malignancies –

DUBLIN, Ohio–(BUSINESS WIRE)– 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.

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

From: http://www.dailyfinance.com/2013/04/11/navideas-presentation-of-top-line-interim-analysis/