Bayer presents positive Phase II data with florbetaben
Potential to visualize beta-Amyloid plaques in Patients with Alzheimer’s disease demonstrated / Florbetaben may innovate the diagnostic capabilities
Vienna, Austria / Berlin, Germany, July 13, 2009 – Bayer Schering Pharma AG, Germany, has presented positive data on a global Phase II study with the novel positron emission tomography (PET) tracer florbetaben (BAY 94-9172) at the International Conference on Alzheimer’s Disease (ICAD) in Vienna, Austria. This study showed that patients with a clinical diagnosis of AlzheimerZs disease could be differentiated from age-matched healthy volunteers (HVs) on the basis of florbetaben uptake pattern in the brain.
Until now, the clinical diagnosis of AlzheimerZs disease (AD) with current methods such as cognitive tests is still limited. Currently, a definite diagnosis of AlzheimerZs disease is only possible post mortem. The results of this study showed PET images with a high specificity of over 90 percent: More than 90 percent of the HVs had a negative florbetaben scan (i.e. no tracer uptake) in the relevant brain regions. The results also show a sensitivity of approximately 80 percent indicated by the clinical diagnosis, meaning that about 80 percent of the clinically suspected Alzheimer patients had positive florbetaben scans indicating the presence of beta-Amyloid plaques. This is in line with the results of studies comparing the clinical diagnosis with the definite post mortem histopathological diagnosis.
“The data underline the potential of florbetaben as an important visual adjunct to existing clinical parameters in the diagnosis of dementia,” said Kemal Malik, MD, member of the Board of Management and Head of Global Development at Bayer Schering Pharma AG. “There is a high medical need for an easy, non-invasive imaging technique that supports an early and precise diagnosis of dementia and especially of Alzheimer’s disease, allowing for optimized care and treatment options.” With the development of florbetaben, Bayer Schering Pharma wants to contribute to diagnose AD in the future more precisely and at an earlier time during the course of the disease.
In the blinded read of the images a high interreader agreement rate between three independent readers was observed. This indicates that the scans with the beta-Amyloid targeted PET tracer florbetaben are easy to visually assess and that this assessment is highly reproducible.
Additional Phase II and pivotal Phase III global studies are under preparation to validate the potential shown by florbetaben in this Phase II setting. Start of the Phase III program is planned for end of 2009.
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