A Look at Neoprobe’s Lymphoseek
Neoprobe Corporation (NEOP) shares continue to rally as investors look forward to positive results from its radioactive tracing agent Lymphoseek. Most tracing agents used now are “off label” and the company believes there is a substantial need for agents with a faster injection site clearance and less “pass through” from sentinel to distal nodes.
Neoprobe Corporation [[NEOP.OB]], a biomedical company focused on enhancing patient care and improving patient outcome, currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. The devices are used to assist in Intraoperative Lymphatic Mapping (ILM) or sentinel lymph node biopsy, a minimally invasive technique for evaluating the spread of cancer to lymph node tissues and organs.
The lymphatic system, also known as the immune system, is an important network of channels and filters that comprise the body’s main line of defense against disease. The defense system may help fight off disease, but it also creates an ideal pathway for cancer cells to travel and spread. As a result, patients who develop a malignant tumor are in danger as the cancer can spread to vital organs like the liver, brain or lungs.
Intraoperative Lymphatic Mapping, or ILM, is a procedure in which a radioactive tracing agent is injected at the site of the primary tumor. The agent then follows the drainage path of the tumor to the nearest lymph node or nodes, known as sentinel nodes. Since these nodes are connected, oncologists believe that if the sentinel nodes show no sign of malignancy, then the downstream notes in the pathway are likely to be clear and removal would not be necessary.
Essentially, Neoprobe’s products help rapidly determine whether cancer has spread or is localized to the site of the primary tumor. Lymphoseek is a patent protected tracing agent that is used with the ILM procedure as the injection. Currently, most of these injections are “off label” uses and are not specifically cleared by regulatory authorities for that intended use. If approved, Lymphoseek would be the first tracing agent specifically labeled for lymph node detection.
Earlier this week, Neoprobe announced a Phase 3 clinical study of Lymphoseek. President and CEO David Bupp commented, “Neoprobe is pleased to announce the initiation of its second Phase 3 study for Lymphoseek. This Phase 3 study, designated internally by Neoprobe as “Sentinel”, is designed to validate Lymphoseek as a sentinel lymph node tracing agent.
The trial will require the accrual of sixty (60) patients with confirmed lymph node disease. The initiation of the second Phase 3 study is a key milestone in the development of Lymphoseek for Neoprobe and we expect the achievement of additional milestones in the coming months.”
CONTACT: Daniel Minton, Managing Director, 406-862-5400, daniel@accelerize.com