Navidea Biopharmaceuticals Announces Enrollment Of First Subject In Phase 2b Trial Of NAV4694 In Subjects With Mild Cognitive Impairment (MCI)

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography (PET) imaging study of [ 18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment (MCI). The study is designed to investigate whether NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with MCI who progress to Alzheimer’s disease (AD) from those who do not. Enrollment is currently planned at approximately five sites throughout the U.S. The first patient has been enrolled by the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.

“We are pleased to participate in this important clinical study of NAV4694 aimed at evaluating a patient population in whom dementia is just emerging and for whom it is believed the best prospects for therapeutic intervention will exist,” said Dr. Anil K. Nair, MD, Chief of Neurology and Head of the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA. “Clinical trial results to date indicate that NAV4694 shows favorable sensitivity and specificity in detecting β-amyloid while exhibiting low white-matter uptake for clearer images that may assist in differential diagnoses associated with MCI. If AD could be diagnosed at an earlier stage, before clinical dementia has fully developed, the potential for successful intervention with current and future treatments could be improved considerably.”

“As the dementia field moves to earlier evaluation and treatment of cognitive impairment, it is of increasing importance to have diagnostic agents that can accurately detect the underlying cause. To our knowledge this is the first prospective, multi-center study to evaluate a radiopharmaceutical β-amyloid agent solely in subjects with MCI, an area of extreme importance as Alzheimer's disease is expected to impact as many as 14 million Americans by 2050,” commented Cornelia Reininger, MD, PhD, Navidea’s Senior Vice President and Chief Medical Officer. “The outcome of this trial may enable accurate differentiation of MCI subjects who are at risk of developing Alzheimer’s disease from those who are not before the disease has reached more advanced stages that can impair activities of daily living. Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia.”

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