Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today announced that the Banner Alzheimer's Institute, Phoenix, AZ, made two presentations of results from an AstraZeneca-sponsored study on the assessment of Navidea's late-stage radiopharmaceutical imaging candidate, AZD4694, at the 6th Annual Human Amyloid Imaging Meeting (HAI), in Miami, FL. In December 2011, Navidea in-licensed the worldwide exclusive rights to AZD4694 from AstraZeneca, now being developed by Navidea as a radiopharmaceutical agent for the detection of cerebral amyloid in Alzheimer's disease (AD) patients.
The two poster presentations, titled, "[18F] AZD4694 PET Quantification for the Assessment of Fibrillar Amyloid-β Deposition" and "[18F] AZD4694 PET in the Assessment of Fibrillar Amyloid-β Deposition: Performance Characteristics," provide additional evidence that [18F] AZD4694 offers promise in the assessment of fibrillar Amyloid-β (Aβ) deposition. Fibrillar Amyloid-β PET ligands may provide useful tools in the scientific study, early detection, tracking and differential diagnosis of Alzheimer's disease and the evaluation of Aβ-modifying treatments.
The findings in this study indicate that [18F] AZD4694 PET in the assessment of fibrillar Aβ deposition in Alzheimer's disease is feasible and relatively straightforward with common analysis methodologies.
"We look forward to conducting additional studies to assess the safety and efficacy of this imaging agent as a potentially effective tool to aid the diagnosis of patients with Alzheimer's disease, a devastating disease that is reaching high levels in the United States and around the world," said Jessica Langbaum, staff scientist at the Banner Alzheimer's Institute.
The Banner Institute presentations at HAI described the use of [18F] AZD4694 in the examination of fibrillar Aβ burden as an aid in the diagnosis of AD. The objective of the first part of the Banner study was to determine an analysis setting for examining the differential fibrillar Aβ burden in three different groups: i) subjects with mild Alzheimer's dementia.
In addition, differences between groups in the AZD4694 PET measurements were seen:
the 8 AD subjects had higher signals than the 9 oHC subjects presumably due to their higher amyloid level; the 8 AD subjects also had higher signals that the 4 yNC subjects; and the 9 oHC subjects had higher signals than the 4 yNC subjects.
The second part of the study used [18F] AZD4694 to characterize fibrillar Aβ burden in subjects with probable mild Alzheimer's disease.
While Navidea undertakes arrangements to commence its Phase III clinical program in early 2013, a number of additional ongoing and planned studies to build the requisite safety and training database will provide further information on AZD4694 during this year.
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