Phase 3 clinical trial of Lymphoseek® (NEO3-05), from NEOP, has been completed showing positive results. Based on positive outcomes, Neoprobe has submitted an end-of-Phase 3 meeting request to the US FDA in order to discuss the results of the clinical trial as part of the continuing preparation of a New Drug Application (NDA), which is planned to file later in 2010.
“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.”
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About Neoprobe
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. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan® CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions
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