News | Radiopharmaceuticals and Tracers | February 18, 2016

First Patient Enrolled in Lymphoseek Cervical Cancer Study

Trial will evaluate effectiveness of imaging agent in identifying sentinel lymph nodes in early-stage cervical cancer

Lymphoseek, cervical cancer study, MD Anderson, sentinel lymph node biopsy, SLNB

February 18, 2016 — Navidea Biopharmaceuticals Inc. last week 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 United States. The first patient has been enrolled by the principal investigator, Michael M. Frumovitz, M.D., MPH, associate professor, Department of Gynecologic Oncology and Reproductive Medicine, at The University of Texas MD Anderson Cancer Center.

A sentinel lymph node is defined as the first lymph node to which cancer cells are most likely to spread from a primary tumor. Sometimes, there can be more than one sentinel lymph node. A sentinel lymph node biopsy (SLNB) is a procedure in which the sentinel lymph node is identified using an imaging agent such as Lymphoseek, removed, and examined to determine whether cancer cells are present. A negative SLNB result suggests that cancer has not developed the ability to spread to nearby lymph nodes or other organs. A positive SLNB result indicates that cancer is present in the sentinel lymph node and may be present in other nearby lymph nodes or organs. This information helps a doctor determine the stage of the cancer and develop an appropriate treatment plan.

“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., MS, FACN, CNS, 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.”

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.

For more information: www.lymphoseek.com

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