Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, has completed a phase-3 clinical trial of Lymphoseek (NEO3-05) with positive results. The phase-3 clinical trial was designed to provide, and achieved its primary endpoint of, the evaluation of the efficacy of Lymphoseek in anatomically delineating lymph nodes in both breast cancer and melanoma patients that may be predictive of determining whether cancer has spread into the lymphatic system. Based on these positive outcomes, Neoprobe has submitted an end-of-phase-3 meeting request to the US FDA to discuss the results of the clinical trial as part of our continuing preparation of a New Drug Application (NDA), which we plan to file later in 2010.
The NEO3-05 clinical trial results confirmed the identification of lymphatic tissue in patients with either breast cancer or melanoma as designed, and when used in conjunction with and compared to vital blue dyes, showed a marked improvement in this identification. Pathological assessment of lymphatic tissue removed during surgery provided further prognostic value in determining the disease state. The Phase 3 trial was designed to determine the accuracy of Lymphoseek to identify lymphatic tissue as compared to commonly used vital blue dyes. The primary objective of the Phase 3 was to obtain at least 203 lymph nodes identified with the vital blue dyes and to statistically demonstrate that 94% of those nodes were identified with Lymphoseek. Procedurecompliant patients in the trial contributed 215 vital blue positive nodes and Lymphoseek identified 210 of those nodes for a success rate of over 97%. In addition, Lymphoseek identified 85 lymph nodes that were missed by the vital blue dyes. Of these Lymphoseek positive nodes, over 18% were found by pathology to contain tumor.
“The filing of the end-of-Phase 3 report is an important milestone in the development process for Lymphoseek,” said David Bupp, Neoprobe’s president and CEO. “We are very pleased with the final results of the phase-3 trial and we look forward to meeting with FDA to discuss the results of the trial and to begin discussions regarding the filing of the NDA to register Lymphoseek for commercial distribution in the United States.”
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients.