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
WAYNE, N.J. and CHICAGO, Nov. 30 /PRNewswire/ -- Today at the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Bayer HealthCare Pharmaceuticals Inc. announced the enrollment of the first patient in an international Phase III clinical trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid plaques in the brain, which are a pathological hallmark of Alzheimer's disease.
At present, diagnosis of Alzheimer's disease is based on cognitive tests that can only indicate a probability of having the disease. A definitive diagnosis of Alzheimer's disease is only possible through a post-mortem autopsy or brain tissue biopsy.
"We are pleased that with the initiation of the florbetaben Phase III clinical trials Bayer is moving forward on the development of a diagnostic tool that has the potential to enable a more definitive and earlier diagnosis of Alzheimer's disease," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals.
Phase III Trial Design
The pivotal phase III trial is an 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 plaques respective to corresponding histo-pathological specimens. Both volunteers without dementia and patients with dementia will be included.
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.
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, Thailand in October 2009.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
SOURCE Bayer HealthCare Pharmaceuticals
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