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News Breaks | | | | January 3, 2013 | | 09:03 EDT |  | NAVB | Navidea reaches interim analysis point of Phase 3 Lymphoseek study
Navidea Biopharmaceuticals announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the company to conduct a pre-planned interim analysis. This Phase 3 trial of Lymphoseek Injection, a novel intraoperative lymphatic mapping agent, is designed to demonstrate the performance of Lymphoseek in identifying sentinel lymph nodes in subjects with squamous cell carcinoma on the head or in the mouth. The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck. This full dissection surgery is considered the gold standard for determining the presence and extent of cancer and staging of the disease in such patients. A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort. Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013. | |
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| June 12, 2013 | | 09:03 EDT | | NAVB | Navidea's Lymphoseek shows positive meta-analysis results
Navidea announced results from a meta-analysis study of Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel, receptor-targeted, small-molecule radiopharmaceutical. The study compared Lymphoseek performance data from a pre-planned interim analysis of its Phase 3 clinical trial versus published data from the ACOSOG Z-0360 trial which was done using radiolabeled sulfur colloid. Results demonstrated that Lymphoseek identified sentinel lymph nodes in subjects with squamous cell carcinoma of the head or neck with a False Negative Rate of 2.56%, whereas sulfur colloid demonstrated an FNR of 10%. Lymphoseek identified SLNs with an overall accuracy of 99%, versus an overall accuracy of sulfur colloid of 97%. | | | June 11, 2013 | | 09:03 EDT | | NAVB | Navidea announces positive results from study of Lymphoseek Injection
 Subscribe for More Information | | | June 10, 2013 | | 16:19 EDT | | NAVB | Navidea announces results from two breast cancer studies
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