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.
“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.
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.
This worldwide study will be conducted at sites on four different continents. For information about enrolling in the study, please visit www.clinicaltrials.gov.
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.
Bayer has decided to extend the Phase II study and is currently recruiting patients in the United States, Germany, Japan, Australia and Switzerland.
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.
CONTACT: Media, Marcy Funk, Bayer HealthCare Pharmaceuticals,
+1-973-305-5385; or Kimberley Jordan, K. Jordan Consulting, +1-202-744-2828
(onsite at RSNA)
Web site: http://www.berlex.com/
