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Affiris Begins Clinical Testing of Alzheimer's Vaccine

23 Jul 2007 - The Alzheimer's vaccine known as Affitope AD01 from Affiris has now entered the clinical phase of its development. All relevant regulatory and statutory approvals have been secured and this innovative treatment is now being tested on humans for the first time. This development means that the 8.5 million-Euro venture capital finance agreement the company concluded with Munich-based MIG-Fonds in April 2006 has reached a key milestone on schedule. Up to 24 Alzheimer's patients are to be vaccinated, with the aim of this initial phase I trial being to demonstrate the vaccine's safety and its suitability for human use. The trial is being run at the Vienna General Hospital and is due to be completed within one year. If it can be successfully proven that the vaccine has a positive safety and suitability profile, the second stage of the clinical development process could begin as early as next year. The aim of this stage in clinical testing would be to demonstrate the vaccine's efficacy, a goal that no treatment anywhere in the world has yet achieved.
 
Affiris GmbH, based in Vienna, Austria, today announced the start of the first phase I clinical trial for its first Alzheimer's vaccine, Affitope AD01. The vaccine is being administered at the Vienna General Hospital (AKH) to up to 24 patients who have reached the disease stage "mild to moderate". The patients will be vaccinated four times over a period of three months, and the safety and suitability of the vaccine will be analysed over six months. A closely meshed care network of the highest medical standards will ensure the patients receive the safest possible treatment.
 
Affiris has developed the Alzheimer's vaccine from patented Affitope technology, which is based on mimotopes and allows customized vaccines to be manufactured cost-effectively. Dr. Schmidt, CEO of Affiris GmbH, explains the special features of Affiris' approach to the Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an unintentionally formed fragment of one of the body's own proteins that occurs on the surface of brain cells and has the scientific abbreviation APP. In principle, it is extremely difficult to develop a vaccine as it is vital to ensure that the immune system only reacts after the beta-amyloid has separated into the brain fluid and not before, when it is present as a healthy component of the APP protein of brain cells. Nobody wants to provoke an immune response against the patient's brain cells. Our approach protects the brain cells and only combats the disease-causing beta-amyloid, irrespective of whether it is still present in its dissolved form in the brain fluid, or has already formed plaque deposits."
 
Affiris specialises in the development of treatments for diseases that urgently require a medical solution and also offer attractive market potential. With 22 million sufferers predicted for 2025 and no effective treatment, Alzheimer's is one such disease. The second major disease that Affiris has chosen to tackle is hardening of the arteries, or atherosclerosis. A customized vaccine is also being developed to treat this disease and is currently still at the pre-clinical stage of development. The companyıs development pipeline is already full, with Affiris' business model envisaging that a new product will enter clinical testing every two years.