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 8th
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."
Highlights of the Presentations