Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek® (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma. The Phase 3 study has been registered on the national clinical trials website www.clinicaltrials.gov.
David Bupp, Neoprobe’s President and CEO, said, “This Phase 3 clinical study is designed to further validate Lymphoseek as a sentinel lymph node tracing agent. Data from this study is not required for the New Drug Application (NDA) for Lymphoseek, which we expect to begin filing with FDA later this summer. The initiation of the third Phase 3 study is another milestone in the development of Lymphoseek and we expect to achieve additional milestones in the coming months for this product.”
Fredrick O. Cope, Ph.D., Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development, said, “NEO3-09 will study approximately 150 patients to provide a statistical sample size of 220 lymph nodes. One of the primary objectives of the Phase 3 study is to demonstrate the superiority of Lymphoseek in identifying lymph nodes draining from breast cancer or melanoma tumors compared to the vital blue dyes currently used in these procedures.”
NEO3-09 is designed to support post-marketing labeling for Lymphoseek after the approval of initial product labeling in the NDA. The first site has already been initiated and begun enrolling patients. In the coming weeks, an additional seven sites are expected to be initiated and commence patient enrollment. Initial results from NEO3-09 are expected to be available in the first quarter of 2011.