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Siemens and UCLA Researchers Get FDA "Green Light" for Clinical Study of Alzheimer's-Specific Imaging Agent

Business Wire, Dec 20, 2006

Study Will Measure the Safety of One of the First Imaging Biomarkers Designed to Differentiate Alzheimer's Disease from Other Forms of Dementia

HOFFMAN ESTATES, Ill. & LOS ANGELES -- Siemens Medical Solutions announced today that it will begin clinical trials under an investigational new drug (IND) application submitted to the Food and Drug Administration (FDA) for a breakthrough imaging biomarker that could potentially identify Alzheimer's disease prior to the onset of noticeable symptoms.

Siemens will collaborate with leading Alzheimer's researchers at the University of California, Los Angeles (UCLA) to launch a Phase I, Open Label, Single Center Safety Study of one of the first imaging biomarkers designed to identify Alzheimer's disease pathology specifically. The study will employ a new diagnostic technique developed by UCLA researchers that combines the new imaging biomarker and positron emission tomography (PET). The technique was first reported in the January 2002 issue of the American Journal of Geriatric Psychiatry.

"The clinical diagnosis of Alzheimer's disease is not definitive, but when it occurs, it is frequently late in the disease progression," said Dr. Jorge R. Barrio, professor of medical and molecular pharmacology, UCLA, and co-inventor of the imaging biomarker. "This means that physicians would treat the disease only after it had already caused brain damage and impaired the patient's memory and daily functioning. Use of this biomarker technology may provide physicians with an early diagnostic tool and information in order to help identify susceptible individuals and allow for the early start of a treatment plan before symptoms appear."

Traditionally, PET, using the currently approved imaging agent 18F-fluorodeoxyglucose (FDG), measures metabolic function in cells. FDG-PET has been used for years in aiding diagnosis of various neurological conditions including Alzheimer's and Parkinson's disease. However, FDG cannot identify the abnormal brain protein deposits - amyloid plaques and tangles - that may cause Alzheimer's. Current anti-dementia drug development is focusing on treating and preventing the accumulation of these deposits.

After Phase 1, the study protocol will focus on the use of the biomarker in patient populations and its potential to seek out tangles and plaques in the living brain of Alzheimer's disease patients. Using PET imaging, biomarker molecules are considered to have the potential to "light up" the parts of the brain with high concentrations of the imaging biomarker; through analysis of the PET data, researchers can thus identify the disease specifically, and do so in advance of the onset of symptoms.

"With this imaging biomarker, we may not only have better early diagnosis of the disease but also the possibility of treating people to delay the onset of symptoms," said Dr. Gary Small, researcher, professor of psychiatry and biobehavioral sciences, UCLA, and co-inventor of the biomarker. "Our goal is to catch the disease in its earliest stages. If the technology proves successful in clinical trials, it could enable us to test new therapies and develop better drugs to manage the progression of the disease over time. It is clearly easier to protect a healthy brain than repair one that is already damaged."

"Siemens' clear objective is to move toward researching the causes of disease, rather than just managing the resulting conditions," said Michael Reitermann, president, Molecular Imaging Division, Siemens Medical Solutions. "By aiding in the detection of diseases at much earlier stages, new imaging biomarkers may ultimately lead toward more personalized medicine."

With imaging biomarkers, Siemens is actively researching and investing in technologies that may support a more personalized approach to medicine. After the Phase I study, depending on its outcome, the company will initiate a larger multi-center clinical trial.

Siemens Medical Solutions of Siemens AG (NYSE:SI) is one of the world's largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics - such as Diagnostic Products Corporation - mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing approximately 36,000 people worldwide and operating in more than 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (preliminary figures). Further information can be found by visiting www.usa.siemens.com/medical-pressroom.>