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.
Dr. Walter Schmidt, CEO of Affiris GmbH, comments on the start of the clinical phase: "This, the most important chapter in our company history so far, is a fantastic development for both Alzheimer's sufferers and our investors. Everyone at Affiris is thrilled. We are confident that the start of our clinical trials represents a major new step in the therapy of Alzheimer's disease, an illness that still lacks a fundamentally effective treatment. The need for such a treatment is particularly pressing given the enormous number of sufferers worldwide over 12 million. However, this need is one that not even the "giants" of the pharmaceutical industry can currently meet. Our investors, MIG-Fonds, are naturally also delighted that we have reached this important milestone on schedule."