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Bayer HealthCare Pharmaceuticals Initiates Phase III Trial with Florbetaben PET Tracer for Imaging of Cerebral beta-Amyloid Plaques, a Pathological Hallmark of Alzheimer's Disease
Date:11/30/2009

evaluation of the sensitivity and specificity of the visual assessment of regional tracer uptake in the florbetaben PET images compared to histological verification as well as the quantitative assessment of regional tracer uptake.

This worldwide study will be conducted at sites on four different continents. For information about enrolling in the study, please visit www.clinicaltrials.gov.

About Florbetaben (BAY 94-9172)

Florbetaben is an in-licensed 18F-labeled PET tracer that is currently being investigated for imaging of cerebral beta-Amyloid plaques. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development for Alzheimer's disease, florbetaben might also be able to support the development of these new treatment approaches.

In the Phase II trial, florbetaben demonstrated potential to detect beta-Amyloid plaques in the brain as a pathological hallmark of disease in probable Alzheimer's disease patients. Twenty-nine adverse events (AEs) were reported in 24 subjects (18%) in the Phase II trial. Five subjects (two with probable Alzheimer's disease, three cognitively non-impaired healthy volunteers) had AEs deemed to be related to florbetaben. These included fatigue, "feeling hot", increased blood pressure, hematoma and "shaking of both hands." The most frequent AEs, regardless of relationship, were injection-site changes. All AEs in the trial were mild-to-moderate intensity and resolved during the study period.

Bayer has decided to extend the Phase II study and is currently recruiting patients in the United States, Germany, Japan, Australia and Switzerland.

Results of the Phase II study were presented at the International Conference on Alzheimer's diseases (ICAD) in Vienna, Austria in July 2009 and at the 19th World Congress of Neurology (WCN) in Bangkok, Tha
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SOURCE Bayer HealthCare Pharmaceuticals
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