Human Trials of Alzheimer's Vaccine Begines

VIENNA, July 19/PRNewswire/ -- The Alzheimer's vaccine known as Affitope AD01 from Affiris has now entered the clinical phase of its development and 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.

Affiris GmbH, based in Vienna, Austria, today announced the start of a phase I clinical trial for its 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.

Source: Affiris GmbH

Dr. Walter Schmidt, CEO of Affiris GmbH, comments: "This, the most important chapter in our company history so far, is a fantastic development for both Alzheimer's sufferers and our investors. The need for such a treatment is particularly pressing given the enormous number of sufferers worldwide - over 12 million. Our investors, MIG-Fonds, are naturally also delighted that we have reached this important milestone on schedule."

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 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."

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.