Chalfont St Giles, UK. - GE Healthcare has announced positive results from a Phase I clinical trial of GE-067, a [18F]-labeled PET diagnostic imaging agent being developed by the company to assist in the detection of brain beta-amyloid. The results, presented today at the International Conference on Alzheimer's Disease, Chicago, USA by the Principal Investigator, Professor Rik Vandenberghe, of the University of Leuven, Belgium, show significantly greater brain uptake of GE-067 in Alzheimer's Disease patients compared with healthy volunteers1. The two hour half-life of the [18F] labeled ligand offers the potential for greater clinical accessibility compared with the research compound [11C] PIB.

Currently, post-mortem diagnosis of Alzheimer's disease (AD) is the "gold standard" of disease confirmation, which offers no possibilities to patients and their carers while they are alive. A key focus of AD research is to identify in vivo imaging agents that could potentially assist in the diagnosis of the disease while the patient is alive. The ability to demonstrate whether a patient does or does not have amyloid pathology might not only be used to support a clinician's diagnosis, but could in the future be used to aid treatment decisions if any of the amyloid targeted therapies now in development are successfully approved. [11C] PIB is now the most recognised and widely used research tool for imaging amyloid. A recent study2 from the Pittsburgh group of Klunk and Mathis has demonstrated that the in-vivo image seen with a PIB PET scan mirrors the distribution and intensity of amyloid pathology identified at subsequent autopsy. However, the [11C] labeled form of PIB has a short half-life (20-minutes) which hampers its potential as a routine clinical diagnostic agent. GE Healthcare has pioneered the synthesis of a PIB derivative labeled with [18F] in order to help overcome this significant barrier to potential clinical use. The [18F] form of the ligand, with a much longer half-life of 110 minutes, may offer greater clinical utility and wider accessibility to hospitals.

The Phase I study (presented using the chemical number [18F] AH1100690) consisted of 22 subjects who were injected with the agent GE-067. Initially 6 healthy volunteers had whole body scans to determine the radiation dose. A further 8 healthy and 8 probable AD) subjects had cranial scans with significant amounts of uptake being observed in the probable AD brains compared to the healthy volunteers. These initial results suggest that GE-067 could be used to detect amyloid pathology in vivo and potentially contribute towards future diagnostic and treatment algorithms, subject to performance of confirmatory studies.

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