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.
Source: Navidea Biopharmaceuticals, Inc.