Neoprobe to submit phase II/III Lymphoseek trial data to FDA:
This article was originally published in Clinica
After meeting the primary endpoint in a phase II clinical trial of its Lymphoseek tracer, Neoprobe is preparing to submit both phase II and phase III clinical trials data to the US FDA. The primary endpoint in the phase II trial was for Lymphoseek (Technetium Tc99m DTPA-mannosyl-dextran) to achieve 90% localisation to lymphoid tissue - localisation was reported in 94% of the procedures performed during the study, which was carried out in breast cancer and melanoma patients. Neoprobe, based in Dublin, Ohio, now plans to begin "winding down" its phase II trial activities, collecting 30-day patient safety follow-up information and accumulating data to report to the agency. Lymphoseek is a radioactive targeting agent developed for use with handheld gamma detection devices, such as Neoprobe's neo2000 system, during the surgical procedure, sentinel lymph node biopsy (SLNB).