Neoprobe Corporation Receives Regulatory Clearance For Lymphoseek Clinical Study

DUBLIN, Ohio--(BUSINESS WIRE)--May 11, 2006--Neoprobe Corporation (OTCBB:NEOP - News), a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, today announced that Neoprobe has been granted authorization by FDA to commence patient enrollment in a Phase 2 multi-center clinical study to evaluate the safety and efficacy of Lymphoseek(TM), a lymphatic tissue targeting agent being developed by the Company. The authorization to commence enrollment follows FDA's review of Neoprobe's responses to information requested by FDA in response to prior submissions by the Company regarding the chemistry, manufacturing and control and non-clinical testing of Lymphoseek. Neoprobe intends to enroll up to eighty patients at five of the leading cancer treatment centers in the United States under the amended Phase 2 clinical protocol. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in breast and melanoma cancer patients.

Back to news