In a full regional lymph node dissection procedure, a patient with breast cancer or melanoma may have as many as 20 to 30 lymph nodes removed in order to determine whether or not cancer has spread to other parts of their body. This very invasive procedure frequently causes significant side effects. In the NEO3-05 and NEO3-09 studies combined, Lymphoseek detected an average of 2.4 lymph nodes per patient, whereas vital blue dye detected a similar average of approximately 1.5 lymph nodes per patient. With this relatively small difference in number of nodes removed, Lymphoseek exhibited superior performance in detecting lymph nodes containing cancer, as evidenced by its lower failed detection rate noted above. The average number of lymph nodes detected by Lymphoseek in a much less invasive manner is still far below the number of lymph nodes removed in full regional node dissection procedures, thus potentially sparing the patient the morbidity and side effects commonly associated with more complete regional nodal dissection procedures.

"The NEO3-09 Phase 3 study met its endpoints and confirmed the previous findings of high concordance and superiority demonstrated in the first Phase 3 study, NEO3-05," said Dr. Fred Cope, Neoprobe's Senior Vice President, Pharmaceutical Research and Clinical Development. "Lymphoseek also showed superiority in detecting lymph nodes that contained tumor. This is important because detecting lymph nodes bearing tumor is the underlying reason for performing ILM procedures to enable lymph-node biopsy."

"In clinical studies, Lymphoseek has been shown to be a safe and effective tool for superior detection of lymph nodes and offers an enhanced ability to accurately identify nodes with a high potential of tumor metastases" stated Dr. Mark Pykett, Neoprobe's President and CEO. "This results in lower failed detection rates than the current standard approach in intraoperative lymphatic mapping using vital blue dye. With these encouraging data, our plans are on track to submit the Lymphoseek New Drug Application to the FDA in the third quarter."

Source: Neoprobe Corporation