Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in pre-operative lymphoscintigraphy imaging and in a surgical procedure known as Intraoperative Lymphatic Mapping (ILM). Lymphoseek works by binding to a specific receptor found on the surface of dendritic cells and macrophages, which reside in high concentration in lymph nodes. This receptor-targeted property of Lymphoseek enables it to attach to and remain within first draining lymph nodes.
Two Phase 3 multi-center clinical trials for Lymphoseek in subjects with breast cancer or melanoma have been completed (NEO3-05 and NEO3-09; www.clinicaltrials.gov trial registration numbers NCT00671918 and NCT01106040, respectively). A third Phase 3 clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in subjects with head and neck squamous cell carcinoma is currently ongoing (NEO3-06; www.clinicaltrials.gov trial registration number NCT00911326).
About ILM and LymphoscintigraphyTo date, Lymphoseek is the first and only receptor-targeted agent developed specifically for ILM. ILM is a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide surgeons with guidance on the relative location of lymph nodes to be biopsied. ILM with a radiopharmaceutical is specifically intended to identify for the surgeon the first lymph node(s) to receive lymphatic flow from the primary tumor site. These “Sentinel Lymph Nodes” are removed and analyzed for the presence of malignant cells. By identifying the Sentinel Lymph Nodes prior to surgery, a small incision and focused dissection can be used to remove them. This technique provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.