Bayer Completes Phase II Study On BAY 94-9172 In Alzheimer's Disease Diagnostic Imaging Using Positron Emission Tomography (PET)

Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials;  MRI / PET / Ultrasound
Article Date: 14 Jun 2009 - 2:00 PDT

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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. BAY 94-9172 binds to the beta amyloid protein in the brain, a pathological hallmark of Alzheimer's disease. The data is being analyzed and results will be presented at this years International Conference on Alzheimer's Disease (ICAD) in Vienna.

Additional information on BAY 94-9172 and related research & development programs will be presented at the Society of Nuclear Medicine (SNM) meeting in Toronto on June 13 - 17, 2009.

"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.

Interesting contributions at the Society of Nuclear Medicine (SNM) meeting in Toronto on June 13 - 17, 2009 are listed below:

Test-retest variability of [18F]BAY94-9172 PET in Alzheimer's disease and normal ageing

- Authors: Rowe, C.C.(1); Pejovska, S.1; Mulligan, R.S.(1); Chan, G.(1); Jones, G.(1); Fels, L.(2); Kusi, H.(2); Reininger, C.(2); Rhode, B.(2); Putz, B.(2); O'Keefe, G.(1); Masters, C.L.(3); Villemagne, V.L.(1) (1)Austin Hospital, Melbourne, VIC, Australia; (2)Bayer Schering Pharma AG, Berlin, Germany; (3)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 ß-amyloid in human brains using PET data

- Authors: Becker, G.(1); Barthel, H.(1); Luthardt, J.(1); Patt, M.(1); Hammerstein, E.(2); Eggers, B.(3); Reininger, C.(4); Rohde, B.(4); Hegerl, U.(2); Gertz, H.-J.(2); Sabri, O.(1) Departments of (1)Nuclear Medicine and (2)Psychiatry, University of Leipzig, (3)Arzneimittelforschung Leipzig Ltd., (4)Bayer Schering Pharma AG, Berlin, Germany

- Oral presentation at Dementia II Session: Tracer Properties, Evaluation Methods, Tuesday, June 16, 12:30 PM - 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.(1); Seese, A.(1); Barthel, H.(1); Patt, M.(1); Schildan, A.(1); Zollmann, F.(2); Reininger, C.(2); Rohde, B.(2); Eggers, B.(4); Gertz, H.-J.(3); Hegerl, U.(3); Sabri, O.(1) (1)University Hospital Leipzig, Dept. of Nuclear medicine; (2)Bayer Schering Pharma AG, Berlin; (3)University Hospital Leipzig, Dept. of Psychiatry; (4)Pharmaceutical Research Leipzig GmbH

- Scientific poster presentation at Dosimetry/ISRTRD Posters, Poster session IV: Radiopharmaceutical Chemistry Track Posters,Tuesday, June 16 , 5:15 PM - 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.(1); Saunder, T.H.(1); Gong, S.(1); Pathmaraj, K.U.(1); Tochon-Danguy, H.T.(1); Villemagne, V.(1); Dyrks, T.(2); Dinkelborg, L.(2); Holl, G.(2); Rowe, C.C.(1) (1)Centre for PET, Austin Hospital, Heidelberg, Australia; (2)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 PM - 6:00 PM, Exhibit Hall E/F

About BAY 94-9172

BAY 94-9172 is an inlicensed (18)F-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. Alzheimer's disease is a neuro-degenerative disease and most common cause of severe dementia in the age group over 60 years which may also lead to death. Imaging with (18)F-BAY 94-9172 should offer the possibility to support an early detection of Alzheimer's disease with an in-vivo imaging method. BAY 94-9172 is currently in clinical development.

About the Phase II study

The open-label, nonrandomized, multi-center Phase II study with independent, blinded image evaluation was performed to determine the sensitivity and specificity of the visual assessment of BAY 94-9172 (AV1/ZK) positron emission tomography (PET) images in detecting/excluding cerebral beta amyloid in patients with probable Alzheimer's disease (AD) compared to healthy volunteers (HV). A total of 18 study centers in 4 countries (Australia, Germany, USA, Switzerland) recruited a total of 221 individuals (150 of which were imaged with BAY 94-9172) into the phase II trial in less than 8 months.

About Alzheimer's Disease

Alzheimer's disease affects an estimated 4.5 million people in the United States alone. That number has doubled since 1980 and is expected to exceed 12 million people by 2050 as the U.S. population ages. Worldwide representative epidemiological surveys estimate that 24.3 million people suffer from dementia today with about 4.6 million new cases every year. The number of people affected will double every 20 years to an estimated 81.1 million by 2040.

Source
Bayer HealthCare

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