Bayer Starts Phase III Trial with Florbetaben
Detection of beta-Amyloid plaques in Alzheimer patients possible / Florbetaben could improve current diagnostic tools
Berlin/Chicago, Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis. On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (e.g. Alzheimer’s disease [AD]). In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients.
“Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease,” said Dr. Thomas Balzer, Head of Global Clinical Development Diagnostic Imaging at Bayer Schering Pharma. “This Phase III study could proof that florbetaben can be used as a new tool to detect beta-Amyloid depositions in the brain in vivo. The ability to image beta-Amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment.”
Phase III Trial Design
The pivotal Phase III trial is a worldwide open-label, multi-center, non-randomized single dose study to assess the safety and to determine the sensitivity and specificity of the visual and quantitative assessment of regional tracer uptake of florbetaben in the brain using PET imaging. Approximately 400 individuals are expected to be enrolled in this study. The florbetaben uptake pattern will be visually assessed by independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data. The images will be compared for the presence or absence of cerebral beta-Amyloid respective to corresponding histo-pathological specimens. Both volunteers without dementia and patients with dementia will be included, therefore enrolling subjects with either a high probability of cerebral beta-Amyloid deposition (e.g. subjects with AD) or a low probability of cerebral beta-Amyloid deposition (e.g.non-demented volunteers).
The primary and secondary objectives of the trial are the 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. The primary completion of the study is anticipated for 2011. However, due to histopathology examinations the study is not anticipated to be completed before 2014.
This worldwide study will be conducted at sites on four different continents. For more information about enrolling in the study, please visit www.clinicaltrials.gov.
Phase II Trial Results
The global Phase II, open-label, non randomized, multi-center study aimed to evaluate the efficacy and safety of florbetaben PET in vivo imaging in the detection/exclusion of cerebral beta-Amyloid plaques in patients with mild-to-moderate, probable AD (older than 55 years of age) compared with age-matched healthy volunteers. A total of 18 study centers in four countries (Australia, Germany, USA and Switzerland) screened 213 individuals of whom 150 individuals were imaged with florbetaben receiving a single intravenous injection of the tracer. Reliable, high-quality images were obtained across multiple centers and camera types.
The results of this study showed PET images with a high specificity of more than 90 percent (more than 90 percent of the healthy volunteers had a negative florbetaben scan) in the relevant brain regions. The results also showed 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.
Twenty-nine adverse events (AEs) were reported in 24 of the participants (18 percent) and only five of them were deemed to be related to florbetaben. Most of the AEs were injection site changes. All AEs in the trial were resolved during the study period. Bayer Schering Pharma has decided to extend this study and is currently recruiting patients in USA, Germany, Japan, Australia and Switzerland.
About Florbetaben (BAY 94-9172)
Florbetaben is an inlicensed 18F-labeled PET tracer that specifically binds to deposition of beta-Amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer’s disease. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches. A Phase II study showed that patients with clinical diagnosis of Alzheimer’s disease could be differentiated from age-matched healthy volunteers on the basis of florbetaben uptake pattern in the brain. The results of the Phase II study were presented at the International Conference on Alzheimer’s diseases (ICAD) in Vienna, Austria in July 2009. Find more information at www.viva.vita.bayerhealthcare.com
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