Bayer Schering Pharma AG, Germany, will provide its development candidate florbetaben, a so called PET (positron emission tomography) tracer, to the Swiss-based biopharmaceutical company AC Immune SA, to support a clinical trial in the field of Alzheimer's disease (AD). This study is conducted to develop a therapy option for the treatment of AD. Bayer's novel PET tracer florbetaben will be applied for imaging of beta-Amyloid deposition in the brain of patients undergoing the phase I clinical testing of AC Immune's Alzheimer's vaccine ACI-24. In this collaboration, florbetaben will be tested for the very first time in the development of a potential therapeutic for Alzheimer's patients.
"Bayer Schering Pharma has already demonstrated the potential of florbetaben to image beta-Amyloid deposition in the brain in its own phase II study," said Dr. Thomas Balzer, Head of Global Clinical Development Therapeutic Area Diagnostic Imaging at Bayer Schering Pharma. "The
cooperation with AC Immune enables the collection of valuable clinical data for florbetaben in patients treated with AC Immune's novel therapeutic vaccine."
"This collaboration with Bayer Schering Pharma adds further value to our Alzheimer's vaccine ACI-24," said Prof. Andrea Pfeifer, CEO of AC Immune. "The adoption of a diagnostic imaging substance visualizing the deposition of beta-Amyloid that is targeted by our vaccine can be an important
parameter for dose selection, and will provide useful complementary data. There is a key trend in the industry to co-develop therapy guiding diagnostics alongside drugs for patients. We look forward to working with Bayer's experts in this ground-breaking collaboration."
Currently, there is no diagnostic test on the market that can detect beta-Amyloid deposition in the brain - a pathological hallmark of Alzheimer's disease - in patient's lifetime. Today, the clinical diagnosis of AD is based on cognitive tests, Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans to exclude other dementia diseases. Unfortunately, clinical diagnosis is often made too late and does not always correlate with post-mortem diagnosis. A good diagnostic assay should also help to better evaluate the effect of new treatments in clinical trials as well as correlate better with existing pathological and memory markers. A new diagnostic tool to detect beta-Amyloid in the brain in vivo might also be beneficial in detecting the disease earlier, before the symptoms are too advanced so treatment could be started earlier.
About Florbetaben (18 F)Florbetaben is an inlicensed 18F-labeled PET tracer that specifically binds to deposition of beta-Amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer's disease. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches. A phase II study showed that patients with clinical diagnosis of Alzheimer´s disease could be differentiated from age-matched healthy volunteers on the basis of florbetaben uptake pattern in the brain. The results of this study were presented at the International Conference on Alzheimer's diseases (ICAD) in Vienna, Austria in July 2009. Find more information at http://www.viva.vita.bayerhealthcare.com About ACI-24
ACI-24 is an active vaccine stimulating the patient's immune system to produce beta-sheet conformation-specific antibodies that prevent plaque deposition or enhance its clearance. During preclinical development, the ACI-24 has shown high efficacy in vivo by memory restoration and plaque reduction. The vaccine is also characterized by a very high specificity due to generating a conformation-specific antibody response. The favourable safety profile of ACI-24 is underlined through the absence of local inflammation in relevant models as well as its T-cell independent mechanism shown in preclinical development. About the ACI-24 clinical trial
It is a phase I, randomized, double blind, placebo controlled clinical study with the primary objective of evaluating the safety and tolerability of ACI-24 and a secondary objective of evaluating efficacy (immune response and clinical assessment) in mild to moderate AD patients. Phase I is designed to allow for the identification of the best dose of vaccine to be used further in phase II. Three groups of patients, each receiving a different dose of ACI-24, will be observed. About Alzheimer's Disease Alzheimer's disease is a devastating neuro-degenerative disease and the most common cause of dementia. Most cases of Alzheimer's disease affect people over the age of 60. It is a progressive disease that can lead to premature death. In 2006, estimates suggested that more than 26 million people worldwide were suffering from Alzheimer’s disease. By 2050, this number could reach more than 100 million. At present there is no cure for Alzheimer's disease, but treatments for symptoms, combined with the right services and support, can make life better for the millions of people living with Alzheimer's. About AC Immune SA
AC Immune SA is a Swiss-based biopharmaceutical company and a leader in Alzheimer's disease drug development. AC Immune develops innovative therapeutics with "best in class" potential against Alzheimer's disease and other neurodegenerative diseases along three axes: vaccines, antibodies and small molecules. Among other programs the company is developing an in-house vaccine ACI-24 which commenced phase I/IIa in 2009. Three clinical programs are focused on Alzheimer's disease, and are backed by a rich portfolio of preclinical compounds. The therapeutic molecules are also leveraged for Alzheimer's disease diagnosis and other central nervous system and non-CNS diseases, such as Glaucoma. Find more information at: www.acimmune.com. About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com. About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.