Navidea commences enrollment in [18F]NAV4694 Phase 2 study for Alzheimer's

Sep 19 2012

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced at two sites participating in its Phase 2, open-label, safety and efficacy PET imaging study of [¹⁸F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with probable Alzheimer's disease (AD). The study is designed to compare images from subjects with probable AD with similarly aged and young healthy volunteers (HV). Two trial sites are currently enrolling subjects: Molecular NeuroImaging, LLC in New Haven, CT, which dosed the first patient in the study; and the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.

"We are pleased to participate in this clinical study of NAV4694 which has the potential to help advance diagnostic accuracy in people with Alzheimer's disease," said Danna Jennings, M.D., Clinical Research Director, Molecular NeuroImaging, LLC. "NAV4694 appears to exhibit the strengths of ¹¹C PIB but given that the ligand is labeled with 18 F it offers flexibility and is more practical to use. The data at this point in the development suggest that NAV4694 shows favorable sensitivity, specificity and decreased white-matter uptake that may enable earlier Alzheimer's disease identification, better monitoring of disease progression, and easier scan interpretation."

"In addition to safety and efficacy endpoints, this clinical trial will allow us to evaluate NAV4694 to determine the correlation of the clinical diagnosis with the β-amyloid plaque uptake in PET images of subjects diagnosed with probable AD," commented Frederick Cope, Ph.D., F.A.C.N., C.N.S., Navidea's Senior Vice President, Pharmaceutical Research and Clinical Development. "Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of AD, a disease expected to impact as many as 16 million Americans by 2050."

This 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 in subjects with probable Alzheimer's disease compared with similarly aged and young healthy volunteers. In addition to safety and efficacy objectives, this study also will measure the correlation between neuro-psychiatric test results with the amount of β-amyloid determined by the NAV4694 imaging.