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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.

Don Black, Head of R&D, Medical Diagnostics at GE Healthcare said: "We were excited to see the results from this Phase I study with GE-067 and as a result have initiated a larger study with manufacturing and scanning centres across Europe. We also plan to extend our studies to the United States of America."

Commenting on the results, Rik Vandenberghe, Principal Investigator of the trial and Professor of Neurology at the University of Leuven, Belgium said "The results of this Phase I trial are a very encouraging step forward in our quest to develop a clinically useful diagnostic imaging agent to assist in the early diagnosis of Alzheimer's Disease and directly demonstrate in vivo the presence of abnormal quantities of beta amyloid in an individual's brain. With latest estimates of the incidence of Alzheimer's Disease predicted to quadruple to 106 million by 20503 and with the potential development of amyloid -lowering therapies, there is a critical need for an effective diagnostic product to directly and reliably demonstrate the presence of amyloid deposits as early as possible during the course of the disease and ultimately improve the lives of patients and caregivers."

The PIB series of compounds are licensed by GE Healthcare from The University of Pittsburgh. In 2008, the inventors of PIB, William E. Klunk, MD, PhD, and Chester A. Mathis, PhD, from the University of Pittsburgh, were awarded the prestigious American Academy of Neurology Potamkin Prize for their significant contribution to the imaging of amyloid.

About Alzheimer Disease
Alzheimer's disease is the most common cause of dementia and a leading cause of death worldwide.
Latest estimates put the global prevalence at 26.6 million and forecast that by 2050 the prevalence will quadruple, to leave 1 in 85 people worldwide living with the disease3.

References:
1. Phase I study of the 18F-labelled benzothiazole derivative [18F]AH110690 as a biomarker of AD-related brain amyloidosis Rik Vandenberghe1 et al,. Poster Presentation, International Conference on Alzheimer's Disease 2008.

2. Post-mortem correlates of in vivo PIB-PET amyloid imaging in a typical case of Alzheimer's disease Ikonomovic, M.D. et al. Brain 2008 Jun; 131(Pt 6):1630-45.

3. Forecasting the global burden of Alzheimer's disease. R. Brookmeyer, et al. Alzheimer's and Dementia 2007, Volume 3, Issue 3, Pages 186 - 191.