Lymphoseek Completes Second Successful Phase 3 Clinical Trials

Dublin-based Neoprobe is reporting that, during the second round of Phase 3 clinical trials, its radiopharmaceutical, Lymphoseek, was found to be superior to current standards of care in indentifying cancerous lymph nodes in patients with breast cancer or melanoma.

The 150- patient NEO3-09 study met all primary and secondary endpoints and highlighted the superior performance by Lymphoseek compared to vital blue dye in intraoperative lymphatic mapping (ILM), a procedure in which lymph nodes are identified for biopsy to assess for the presence of tumor. It further showed no “clinically adverse events” in the trial. 

“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,” said Mark Pykett, president and CEO of Neoprobe.  “With these encouraging data, our plans are on track to submit the Lymphoseek New Drug Application to the FDA in the third quarter.”

For more details, see the release from Neoprobe.