DUBLIN, Ohio–(BUSINESS WIRE)–Feb. 11, 2016– Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today announced that the first patient has been enrolled in a clinical study evaluating Lymphoseek® (technetium Tc 99m tilmanocept) injection in women with known cervical cancer. The study, funded by a Fast-track grant from the National Institutes of Health (NIH), National Cancer Institute (NCI; 1R44CA180390-01) will assess the use of Lymphoseek in sentinel lymph node biopsy (SLNB) during cervical cancer surgery in support of the existing Lymphoseek label in lymphatic mapping. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Enrollment is currently planned in up to six sites throughout the U.S. The first patient has been enrolled by the principal investigator, Michael M. Frumovitz, M.D., M.P.H., Associate Professor, Department of Gynecologic Oncology and Reproductive Medicine, at The University of Texas MD Anderson Cancer Center.
“This important study could potentially advance the use of SLNB procedures in cervical cancer. Clinical experience and published results using Lymphoseek in other cancer types demonstrate that imaging using Lymphoseek may enable detection of suspicious nodes not previously possible,” said Frederick Cope, Ph.D., M.S., F.A.C.N., C.N.S., Senior Vice President and Chief Scientific Officer of Navidea. “Improving current practice in lymph node mapping and sentinel node detection in cervical cancer surgery may lead to less extensive, more focused surgical procedures. More reliable bilateral SLN identification may decrease the cost and morbidity of complete lymph node dissection in women with early stage cervical cancer.”
“There is currently a growing focus on sentinel lymph node biopsy (SLNB) procedures in gynecologic cancers. Lymphoseek has been safely and efficaciously used in SLNB and mapping procedures in over 50,000 patients to date,” said Rick Gonzalez, President and Chief Executive Officer of Navidea. “With Lymphoseek’s immunodiagnostic properties of selective receptor targeting and improved patient experience, we believe that this study and others like it may accelerate the adoption of lymphatic mapping and SLNB using Lymphoseek in cervical cancer and other solid tumor areas with the intent of improving patient outcomes and reducing post-surgical morbidities in patients undergoing these procedures.”
This multi-center, prospective, open-label study is designed to evaluate Lymphoseek® in patients with known cancer of the cervix. The trial intends to enroll up to 40 women with International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1 staging. Subjects will receive a single dose of Tc99m tilmanocept administered peritumorally approximately 1-2 hours before surgery. The results will report per-patient false negative rates and compare the pathology status of Lymphoseek-identified sentinel lymph nodes relative to the pathology status of non-sentinel lymph nodes in nodal staging of patients. Additionally, the study will report sensitivity, negative predictive value, and accuracy. Concordance and reverse concordance of identified nodes will be reported for the cases that use both Lymphoseek and a dye. Information on the protocol for this study (NAV3-19) can be found at: https://www.clinicaltrials.gov/ct2/show/NCT02509585?term=lymphoseek&rank=5.