Navigation Links
Bayer HealthCare Presents Florbetaben Phase II Study Results at World Congress of Neurology
Date:10/30/2009

BANGKOK, Oct. 30 /PRNewswire/ -- Bayer HealthCare presented results from a global Phase II study of florbetaben, its imaging agent in development for the detection of cerebral beta-Amyloid plaques, at the 19th World Congress of Neurology (WCN).

The purpose of the Phase II study was to investigate the efficacy of florbetaben in differentiating between patients with a clinical diagnosis of probable Alzheimer's disease and Healthy Volunteers (HVs). Participants were evaluated using visual assessment of the uptake pattern of florbetaben in the brain and its ability to detect or exclude cerebral beta-Amyloid plaques. Cerebral beta-Amyloid plaques are one of the pathological hallmarks of Alzheimer's disease.

Current diagnosis of Alzheimer's disease is based on cognitive tests that can only indicate a probability of having the disease. A definitive clinical diagnosis of Alzheimer's disease is only possible through a post-mortem autopsy or brain tissue biopsy.

Florbetaben (BAY 94-9172) is an investigational positron emission tomography (PET) imaging tracer. In the global Phase II, open-label, non-randomized, multi-center study, florbetaben was used to detect or exclude the presence of cerebral beta-Amyloid plaques. A total of 81 men and women with probable mild-to-moderate Alzheimer's disease and 69 cognitively non-impaired healthy volunteers aged 55 and older were imaged with a single intravenous injection of florbetaben. The florbetaben uptake pattern was visually assessed for all time points by three independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data.

Results showed that PET images using florbetaben had a specificity of approximately 90 percent. This means that the florbetaben scan indicated the presence of cerebral beta-Amyloid plaques in approximately 10 percent of the healthy volunteers. The results also showed a sensitivity of approximately 80 percent, meaning that about 80 percent of the subjects with probable Alzheimer's disease had florbetaben scans indicating the presence of cerebral beta-Amyloid plaques. This is consistent with the results of studies where the clinical diagnosis of Alzheimer's disease was compared with the definitive post-mortem histopathological diagnosis. Additional data analysis is still ongoing in this study.

There were twenty-nine treatment-emergent AEs, the most-frequent of which were injection site changes, were reported in 24 subjects (16 percent), 10 of whom were patients with probable Alzheimer's disease and 14 of whom were healthy volunteers. In two patients with probable Alzheimer's disease and three healthy volunteers, the AEs were deemed to be related to florbetaben, and included fatigue, "feeling hot", increased blood pressure, hematoma and "shaking of both hands." All adverse events (AEs) in the trial were resolved during the study period.

"Alzheimer's disease can be devastating for its victims and their families, and represents a large and growing cost burden for society," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "At Bayer HealthCare Pharmaceuticals, we are pleased that these encouraging results from our phase II studies suggest the potential of florbetaben PET imaging as a valuable tool for the detection of the hallmark indicator associated with Alzheimer's disease."

About Florbetaben

Florbetaben is an in-licensed 18F-labeled PET tracer currently being investigated for imaging of cerebral beta-Amyloid plaques, which are one of the pathological hallmarks of Alzheimer's disease. It is a leading candidate in Bayer's efforts to build a strong pipeline of PET tracers in neuroimaging, oncology, and cardiovascular disease. Additional Phase II and pivotal Phase III global studies are under preparation to validate the potential shown by florbetaben in this Phase II setting. Start of the Phase III program is planned for end of 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.

SOURCE Bayer HealthCare Pharmaceuticals


'/>"/>
SOURCE Bayer HealthCare Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Bayer and Onyx Announce Nexavar Data Presentations at 60th American Association for the Study of Liver Diseases Annual Meeting
2. Bayers Novel Anti-Cancer Compound Regorafenib (BAY 73-4506) Showed Stabilization or Regression in 81 Percent of Kidney Cancer Patients
3. Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009
4. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
5. Bayer Announces New Data on Novel Anti-cancer Compound BAY 73-4506
6. Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting
7. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
8. Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology
9. FDA Approves Bayer HealthCares Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
10. Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
11. Cell Therapeutics, Inc. (CTI) to Hold Conference Call to Discuss Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2017)... July 31, 2017 7D Surgical, developer of ground ... purchased the 7D Surgical System to support its strategic sales ... D.C. and Virginia.  7D Surgical has entered into ... of the premier medical facilities within those markets. ... ...
(Date:7/27/2017)... Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results ... reported second quarter net sales of $1.954 billion, an ... an increase of 2.1% on a constant currency basis.  ... LDR Holding Corporation acquisition, second quarter 2017 revenues decreased ... on a constant currency basis. ...
(Date:7/26/2017)... a leading medical aesthetic clinic in Singapore ... conditions from the inside. The natural process of aging ... becomes more transparent due to the thinning of the epidermis. Over the ... sun contributes to aging skin, causing age spots and other types ... ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... ... Overseer at The House of Yahweh in Abilene, Texas, has released a new publication this ... of the Savior whom the world calls “Mother Mary”. Yisrayl says when compared to what ... historical woman. , “The world bows, kisses the feet of, cries out to and ...
(Date:8/18/2017)... ... August 18, 2017 , ... 800response, the leading ... solutions, announced today the launch of a redesigned corporate website, 800response.com . ... fully responsive design, and an enhanced search directory for businesses and advertising agencies ...
(Date:8/18/2017)... ... ... “Three Narrow Roads”: a vivid and provocative look into the narrow path toward ... Sr., is currently the pastor-teacher-visionary at Simply the WORD Church, a global prayer ministry ... program geared towards youth. , King shares, “When I take time to think about ...
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... ... and marketers of high-quality anti-aging skincare solutions, recently announced the launch ... new products are an affordable, yet effective alternative to expensive plastic surgery or ...
(Date:8/18/2017)... ... ... “Steve the Snake”: an entertaining and moral-based short story about an unkind snake ... Flash Haskins Jr., a husband, father and grandfather who served as a U.S. Marine, ... short stories for children and teens. My goal is to teach kids to use ...
Breaking Medicine News(10 mins):