Neoprobe Submits Phase 3 Data to FDA (OTC:NEOP)

Neoprobe Corporation (OTC:NEOP) has announced that they have completed their Phase 3 clinical trial of Lmyphoseek (NEO3-35) with positive results and that they have submitted the data to US Food and Drug Administration to discuss the results of the clinical trial as part of our continuing preparation of a New Drug Application (NDA), which they plan to file later in 2010. 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.

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. 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. Neoprobe’s CEO and President, David Bupp mentioned that the filing of the end-of-Phase 3 report is an important milestone in the development process for Lymphoseek and that they are very pleased with the final results of the Phase 3 trial and we look forward to meeting with FDA to discuss further plans.

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