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Navidea Biopharmaceuticals Inc announces positive initial results in Single-Center Cohort from phase 2b trial of NAV4694 in subjects with Mild Cognitive Impairment (MCI)

Thursday, 6 Feb 2014 09:15am EST 

Navidea Biopharmaceuticals Inc:Says the company's investigational beta-amyloid imaging agent, NAV4694, produced highly differentiated images in the first cohort of subjects enrolled in the company's Phase 2b positron emission tomography (PET) imaging study of subjects with Mild Cognitive Impairment (MCI).Says the subjects were enrolled and evaluated at the Alzheimer's Disease Center at Quincy Medical Center, Quincy, MA.Says the results indicate that NAV4694 produced high-quality diagnostic images that segregated MCI subjects into two discrete groups, either amyloid-positive or amyloid-negative.Says the image evaluation was performed on twelve subjects meeting pre-defined inclusion/exclusion criteria for emerging, or early-stage, cognitive impairment. NAV4694 scans were assessed by two independent readers using a 3-point visual scale.Says Image interpretation used the company's proprietary visual-read algorithm.Says the technical quality of the scans was good and both raters were in complete agreement on the 3-point scale, with 8 scans highly positive for β-amyloid and 4 scans negative.Says there were no intermediate ratings or ambiguous cases despite the early-stage characterization of the subjects' cognitive impairment status.Says the scans were easy to read and the readers noted that the high gray matter relative to white matter signal made image interpretation very straight forward. To date, the product candidate appears to be safe and well-tolerated. 

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