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

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 ??-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