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January 15, 2013
08:04 EDTNAVBNavidea completes study of radiopharmaceutical NAV4694
Navidea Biopharmaceuticals announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral b-amyloid in diagnosing Alzheimer's disease, or AD. The study was designed and conducted by Navidea's partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694, or NAV4694, on safety and the efficacy of Positron Emission Tomography scanning in subjects with AD and in healthy volunteers. Evaluations were completed on the effects of two mass doses of the radioligand on binding parameters and overall image quality. These endpoints are typical and important requirements of drug registration dossiers filed with regulatory authorities for approval of diagnostic agents.
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June 12, 2013
09:03 EDTNAVBNavidea'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 EDTNAVBNavidea announces positive results from study of Lymphoseek Injection
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June 10, 2013
16:19 EDTNAVBNavidea announces results from two breast cancer studies
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