Bayer’ Florbetaben Shows Positive Results

Bayer Schering has reported positive results for the phase-II study of the novel positron emission tomography (PET) tracer florbetaben (BAY 94-9172).

The study showed that patients with Alzheimer’s disease could be differentiated from healthy volunteers, on the basis of florbetaben uptake pattern in the brain.

The results of the study showed PET images with a high specificity of over 90%. More than 90% of the healthy volunteers had a negative florbetaben scan in the relevant brain regions.

Additionally, about 80% 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 phase-II and pivotal phase-III global studies are under preparation to validate the potential shown by florbetaben in this phase-II setting. The phase-III program is planned for end of 2009.