Today AFFiRiS AG announced an important step forward in the development of its vaccine for Parkinson's disease. The vaccine, known as PD01, has undergone numerous preclinical tests which have confirmed its principle of action ("Proof of Concept"). The company is now starting to prepare for clinical trials of the vaccine which are planned to commence at the beginning of 2011. Due to a completely innovative effect approach this vaccine could for the first time offer a chance of treating the causes of Parkinson's disease. The basis of PD01 is the company's AFFITOM(R) technology, on which two vaccines for Alzheimer's disease are based that have already successfully completed their initial clinical studies.
AFFiRiS AG, which is based in Vienna, Austria, today announced the results of the preclinical development of its first Parkinson's vaccine PD01. This Parkinson's vaccine specifically acts against a protein known as alpha-synuclein (alpha-syn) which strongly contributes to the clinical profile of Parkinson's disease.
Referring to the successful completion of the preclinical development phase, Dr Walter Schmidt, director and co-founder of AFFiRiS AG stated: "We have had PD01 evaluated in various preclinical systems. All the tests have shown that this vaccine works against alpha-syn. In addition to histological and biochemical analyses, we have even been able to observe behavioural improvements as a result of our vaccination. We are now starting preparations for the clinical trial of PD01 which will supplement our current clinical programmes".
The vaccine PD01 takes advantage of the fact that accumulations and the associated deposition of alpha-syn in the brain are partly responsible for the progression of Parkinson's disease. A reduction in the alpha-syn concentration in the brain should therefore have a positive effect on the clinical progression of Parkinson's. It is precisely here where PD 01 acts, as the vaccine triggers an effective immune response to the harmful alpha-syn, as a result of which the body's own immune system reduces the alpha-syn. AFFiRiS is now able to announce the successful outcome of the preclinical phase confirming the effectiveness of this principle.
To quote Dr Frank Mattner, CSO: "Alpha-syn is an attractive target for treating Parkinson's causally and not just symptomatically. However, it must be remembered that alpha-syn is an endogenous protein belonging to a family of proteins whose members have extensive sequence homologies. For example, as a so-called neuroprotective factor, the member of this protein family known as beta-syn is important for a healthy body. A vaccination aimed at reducing alpha-syn must therefore ensure that the triggered antibody immune response exclusively addresses alpha-syn, but leaves beta-syn untouched. Our AFFITOM(R) technology allows us to develop vaccines that guarantee this high level of specificity to alpha-syn. During 2010 we will complete the preliminary work for the clinical trial".
On the basis of this technology AFFiRiS AG has already announced the development of two vaccines for Alzheimer's, one for atherosclerosis and as recently published a vaccine against hypertension; that is to say conditions that affect hundreds of millions of people. Indeed, the commercial significance of the AFFITOM(R) technology has also been recognised by the pharmaceutical industry and by 2008 a technology licence based on this with a total value of up to 430 million Euros was granted to GSK Biologicals for the development of the Alzheimer's vaccines.
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