June 12, 2009 – Bayer Schering Pharma AG, Germany, has completed its first global Phase II study analyzing the sensitivity and specificity of BAY 94-9172 (AV1/ZK) using positron emission tomography (PET) in patients with probable Alzheimer's disease compared to healthy volunteers. Information on BAY 94-9172 and related research and development programs will be presented during the Society of Nuclear Medicine (SNM) meeting in Toronto on June 13 - 17, 2009.
BAY 94-9172, currently in clinical development, is a 18F-labeled PET tracer and binds to beta amyloid, a protein that accumulates in the brain and that is considered being a pathological hallmark of Alzheimer's disease. Imaging with 18F-BAY 94-9172 should offer the possibility to support an early detection of Alzheimer's disease with an in-vivo imaging method.
"Beta amyloid has been proven to be a pathological hallmark of Alzheimer's disease and it is accumulated in the brain very early in the course of the disease. Currently, the detection of this protein and, thus, the definitive diagnosis of Alzheimer's disease is only possible upon post-mortem," said Thomas Balzer, M.D., head of Global Clinical Development Therapeutic Area Diagnostic Imaging. "Thus an in-vivo imaging method would be clinically very useful as it could help in the differentiation between different dementia forms and either exclude Alzheimer's disease or make it very likely. There is a high unmet medical need for a better and earlier differentiation between the various dementia forms and especially of Alzheimer's disease. We hope that BAY 94-9172 can contribute to this for the patient's benefit because an earlier and more accurate diagnosis allows for optimized care and treatment options," he added.
Bayer Schering Pharma has extended its Phase II program to further expand the number of imaged individuals and will also begin its pivotal Phase III global clinical development program of BAY 94-9172 in the second half of this year.
Related contributions at the Society of Nuclear Medicine (SNM) meeting in Toronto on June 13 - 17, 2009, include the following:
Test-retest variability of [18F]BAY94-9172 PET in Alzheimer's disease and normal ageing.
- Authors: Rowe, C.C.; Pejovska, S.; Mulligan, R.S.; Chan, G.; Jones, G.; Fels, L.; Kusi, H.; Reininger, C.; Rhode, B.; Putz, B.; O'Keefe, G.; Masters, C.L.; Villemagne, V.L.
Austin Hospital, Melbourne, VIC, Australia; Bayer Schering Pharma AG,
Berlin, Germany; The Mental Health Research Institute of Victoria, Melbourne, VIC, Australia.
- Scientific poster presentation at Neurology Posters, Poster Session I:
Multimodality and Non-Radioactive Molecular Imaging, Educational Exhibits, Cardiovascular & Neuroscience Track Posters.
Monday, June 15, 2:30 PM - 3:15 PM, Exhibit Hall E/F
Kinetic modeling of BAY94-9172 binding to beta-amyloid in human brains using PET data.
- Authors: Becker, G.; Barthel, H.; Luthardt, J.; Patt, M.; Hammerstein, E.; Eggers, B.; Reininger, C.; Rohde, B.; Hegerl, U.; Gertz, H.-J.; Sabri, O. Departments of Nuclear Medicine and Psychiatry, University of Leipzig, Arzneimittelforschung Leipzig Ltd., Bayer Schering Pharma AG, Berlin, Germany
- Oral presentation at Dementia II Session: Tracer Properties, Evaluation
Tuesday, June 16, 12:30 - 2 PM, Room 701A
Quantification of the radiation risk caused by [F18]BAY94-9172, a new PET tracer for detection of cerebral beta-amyloid plaques.
- Authors: Sattler, B.; Seese, A.; Barthel, H.; Patt, M.; Schildan, A.; Zollmann, F.; Reininger, C.; Rohde, B.; Eggers, B.; Gertz, H.-J.; Hegerl, U.; Sabri, O. University Hospital Leipzig, Dept. of Nuclear medicine; Bayer Schering Pharma AG, Berlin; University Hospital Leipzig, Dept. of Psychiatry; Pharmaceutical Research Leipzig GmbH
- Scientific poster presentation at Dosimetry/ISRTRD Posters.
Poster session IV: Radiopharmaceutical Chemistry Track Posters.
Tuesday, June 16 , 5:15 - 6:00 PM, Exhibit Hall E/F
Comparisons of Animal-Human Translated and Human 18F-BAY94-9172 Amyloid Radiation Dosimetry.
- Authors: O'Keefe, G.J.; Saunder, T.H.; Gong, S.; Pathmaraj, K.U.; Tochon-Danguy, H.T.; Villemagne, V.; Dyrks, T.; Dinkelborg, L.; Holl, G.; Rowe, C.C. Centre for PET, Austin Hospital, Heidelberg, Australia; Bayer Schering Pharma AG, Berlin, Germany
- Scientific poster presentation at Dosimetry/ISRTRD Posters: Posters Session IV: Radiopharmaceutical Chemistry Track Posters.
Tuesday, June 16, 5:15 - 6:00 PM, Exhibit Hall E/F