Affiris begins clinical testing of Alzheimer’s vaccine

Vienna, 19th July 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.

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.”

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, 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 company’s development pipeline is already full, with Affiris’ business model envisaging that a new product will enter clinical testing every two years.

About AFFiRiS GmbH (as at May 2007):
AFFiRiS GmbH develops peptide-based vaccines for the treatment of Alzheimer’s disease, atherosclerosis and other serious diseases. The company has established platform technologies and registered the corresponding patent families. The first patents have already been issued. The company employs 30 highly qualified members of staff on 600 sqm of rented laboratory facilities at the Campus Vienna Biocenter (www.affiris.com).

About MIG-Fonds:
The participation of MIG Verwaltungs AG in Affiris GmbH represents the continuation of a tried-and-tested approach. Investment is only made in selected companies in Germany and Austria after their viability has been thoroughly audited. Their innovative, high-potential products and the entrepreneurial skills of their management teams are both key. MIG Verwaltungs AG is supported by Alfred Wieder AG. This specialist in venture capital is experienced in the sale of holdings and is therefore the first point of contact for any potential investors.

Contact for Affiris GmbH:
Dr. Walter Schmidt
Campus Vienna Biocenter 2
A-1030 Vienna, Austria
T +43 / 1 / 798 1575 10
E [email protected]
W www.affiris.com

Distribution:
PR&D – Public Relations for Research & Development
Campus Vienna Biocenter 2
A-1030 Vienna, Austria
T +43 / 1 / 505 70 44
E [email protected]

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