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Navidea Biopharmaceuticals Inc Announces Results Of Lymphoseek Phase 3 Clinical Trials In Breast Cancer Published In Annals of Surgical Oncology

Thursday, 21 Mar 2013 09:00am EDT 

Navidea Biopharmaceuticals Inc announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek (technetium 99m tilmanocept) Injection in patients with breast cancer. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping. Results demonstrated that Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with VBD. The study, Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials, was published in the current online edition of the journal Annals of Surgical Oncology. Two Phase 3 non-randomized trials were conducted in patients with breast cancer undergoing lymphatic mapping. The primary endpoint was the rate of agreement (concordance) between [99mTc]tilmanocept and vital blue dye, which was defined as the proportion of lymph nodes identified by VBD that were also identified by Lymphoseek. A pre-specified minimum rate of agreement of 90% had been established in the trials` statistical plan. In the trials, a total of 148 patients with breast cancer from 13 centers received [99mTc]tilmanocept followed by vital blue dye and then underwent sentinel lymph node mapping. Lymph nodes that demonstrated [99mTc]tilmanocept uptake and/or the presence of blue dye were removed and examined for the presence of tumor. 

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-0.21 -10.50%
26 Dec 2014