Phase 3 Trial Update of Lymphoseek for Lymphatic Mapping in Breast Cancer

Navidea Biopharmaceuticals announced a meta-analysis and pooled-data comparison of results of prospective Phase 3 clinical trials of Lymphoseek (99m-Tc-Tilmanocept) in patients with breast cancer, to historical data on sulfur colloid from documents filed with the FDA related to sulfur colloid labeling for breast cancer lymphatic mapping.

Two key parameters were evaluated in the study: the localization rate (LR) of the agents per patient population and the degree of localization (DL) or number of nodes in which the agent localized per patient. Both parameters were evaluated using meta-analysis and pooled-data approaches. The meta-analyses revealed that in the breast cancer patients studied, Lymphoseek's LR was 99.91% by meta-analysis and 98.65% by pooled data analysis, whereas the sulfur colloid LR derived from peer-reviewed literature was 94.13% (P<0.0001/meta-analysis; P<0.0015/pooled analysis). Similarly, Lymphoseek's DL in the breast cancer patients studies was 2.1 by meta-analysis and 2.2 by pooled data analysis, compared to the sulfur colloid DL from peer-reviewed literature of 1.6 (P <0.0001/meta-analysis; P <0.0001/pooled analysis).

Lymphoseek is a proprietary radioactive diagnostic tracing agent developed for use in connection with gamma detection devices in ILM. 

For more information call (800) 793-0079 or visit www.navidea.com.