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Navidea commences Lymphoseek pediatric study

  • The first patient is enrolled in Navidea Biopharmaceuticals' (NAVB -2.3%) Phase 2 study comparing the lymph node-identifying capability of Lymphoseek (technetium Tc 99m tilmanocept) to vital blue dye (VBD) in 32 pediatric patients with melanoma, rhabdomyosarcoma or other solid tumors.
  • Lymphoseek, currently approved for use only in adults, is a radiopharmaceutical imaging agent designed to precisely identify lymph nodes that drain from a primary tumor, ones that have the highest probability of harboring cancer cells.
  • The study, called NAV3-18, is a prospective, open-label, multicenter trial in pediatric patients with certain cancers who are undergoing lymph node mapping. In addition to safety and tolerability, it will primarily assess the in vivo detection rates of Lymphoseek and VBD in excised lymph node tissue. According to clinicaltrials.gov, the estimated study completion date is July 2018.

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