Navidea Biopharmaceticals, Inc. (NAVB) Reports First Patient Enrolled in Phase 2 Trial of NAV4694

Navidea Biopharmaceticals is a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals. The company is developing four radiopharmaceutical agent platforms – Lymphoseek, RIGScan, CFT, and NAV4694 – to help identify the sites and pathways of undetected disease and improve diagnostic accuracy, clinical decision-making, and patient care.

The company announced today that enrollment has begun at two sites participating in its Phase 2, safety and efficacy PET imaging study of NAV4694 for detection of cerebralβ-amyloid plaque in subjects diagnosed with probable Alzheimer’s disease. The sites are the Alzheimer’s Disease Center at Quincy Medical Center in Quincy, MA, and Molecular NeuroImaging LLC, in New Haven, CT, which dosed the first patient in the study.

The study is a Phase 2, open-label, multiple-center, non-randomized single dose, PET imaging study to assess the safety and efficacy of [18F]NAV4694 in detecting β-amyloid plaque in the brain of subjects with probable Alzheimer’s disease in comparison to similarly aged subjects without the disease and also young, healthy volunteers. The study will also measure the correlation between neuro-psychiatric tests results with the amount of β-amyloid determined by the NAV4694 imaging.

The goal of Navidea is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of Alzheimer’s disease, a disease expected to impact as many as 16 million Americans by the year 2050. For additional information about Navidea Biopharmaceuticals, NAV4694, and its other diagnostic radiopharmaceuticals, please visit the company’s website at www.navidea.com.

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