Lymphoseek® Data Presented By Independent Investigators At 8th International Conference On Head And Neck Cancer

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, noted today that individual site, investigator-initiated results of an ongoing Phase 3 clinical trial of 99m-Tc-Tilmanocept (Lymphoseek ^®) were presented at the American Head and Neck Society’s 8 ^th International Conference on Head and Neck Cancer (ICHNC), held in Toronto, July 21-25, 2012. Investigators from the University of Texas MD Anderson Cancer Center, The Ohio State University and the University of Miami reported their personal experiences with the use of Lymphoseek in head and neck squamous cell carcinoma.

“Our initial clinical experience with 99m-Tc-Tilmanocept has demonstrated its utility, diagnostic predictive value and safety in our patients, both preoperatively in lymphoscintigraphy and for intraoperative localization,” said Dr. Stephen Y. Lai, M.D., Ph.D., FACS, of the University of Texas MD Anderson Cancer Center. “In determining the extent of early-stage oral cavity squamous cell carcinoma, we are evaluating the efficacy of sentinel lymph node (SLN) biopsy to improve staging and direct treatment of our patients. Many patients have more than one SLN in the head and neck, so the ability of a product such as Lymphoseek to accurately identify and map SLNs can facilitate accurate staging and may potentially decrease some patients’ extent of surgery, thus reducing possible serious morbidity.”

“The data reported on the performance of Lymphoseek in identifying sentinel lymph nodes in head and neck squamous cell carcinoma at ICHNC from independent site investigators, although not from Navidea, appear promising. We look forward to reviewing the full data sets from these institutions at the appropriate time as part of the customary process of our Phase 3 clinical study,” said Fred Cope, Ph.D., Navidea’s Senior Vice President of Pharmaceutical Research and Drug Development. “Navidea continues to look forward to the PDUFA date of September 10, 2012, for the use of Lymphoseek in lymphatic mapping in cancer patients. We believe that in comparing Lymphoseek performance to a pathology truth standard, the head and neck Phase 3 study may provide additional data in support of an augmented label for Lymphoseek aimed at sentinel lymph node biopsy.”

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