Neoprobe Corporation announced results from its Phase 3 study of Lymphoseek (99mTc-tilmanocept) a diagnostic and surgical oncology product developed for intraoperative lymphatic mapping (ILM) procedures. In the NEO3-05 study, Lymphoseek met all primary and secondary endpoints. The primary endpoint of the NEO3-05 trial was the comparison (the Concordance Rate, or the rate of agreement) of Lymphoseek vs. vital blue dye (VBD), the only on-label agent approved in the U.S. for lymphatic mapping. Lymphoseek demonstrated statistically significant Concordance Rates on both a per-node and per-patient basis. Study subjects yielded a total of 215 lymph nodes stained with VBD. Of these blue-stained nodes, Lymphoseek detected 210, for a Concordance Rate of 97.67% (P<0.0001). On a per-patient basis, a total of 136 patients had lymph nodes stained with VBD. Of these patients, Lymphoseek detected the same blue-stained nodes in 131 patients, for a Concordance Rate of 96.32% (P<0.0001).
Lymphoseek is a proprietary radioactive diagnostic tracing agent developed for use in connection with gamma detection devices in ILM.
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