Parkinson Vaccination: Good Start to the Spring for AFFiRiS AG

Wednesday, March 31, 2010 General News
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VIENNA, Austria, March 30, 2010 Today AFFiRiS AGannounced an important step forward in the development of its vaccine forParkinson's disease. The vaccine, known as PD01, has undergone numerouspreclinical tests which have confirmed its principle of action ("Proof ofConcept"). The company is now starting to prepare for clinical trials of thevaccine which are planned to commence at the beginning of 2011. Due to acompletely innovative effect approach this vaccine could for the first timeoffer a chance of treating the causes of Parkinson's disease. The basis ofPD01 is the company's AFFITOM(R) technology, on which two vaccines forAlzheimer's disease are based that have already successfully completed theirinitial clinical studies.

AFFiRiS AG, which is based in Vienna, Austria, today announced theresults of the preclinical development of its first Parkinson's vaccine PD01.This Parkinson's vaccine specifically acts against a protein known asalpha-synuclein (alpha-syn) which strongly contributes to the clinicalprofile of Parkinson's disease.

Referring to the successful completion of the preclinical developmentphase, Dr Walter Schmidt, director and co-founder of AFFiRiS AG stated: "Wehave had PD01 evaluated in various preclinical systems. All the tests haveshown that this vaccine works against alpha-syn. In addition to histologicaland biochemical analyses, we have even been able to observe behaviouralimprovements as a result of our vaccination. We are now starting preparationsfor the clinical trial of PD01 which will supplement our current clinicalprogrammes".

The vaccine PD01 takes advantage of the fact that accumulations and theassociated deposition of alpha-syn in the brain are partly responsible forthe progression of Parkinson's disease. A reduction in the alpha-synconcentration in the brain should therefore have a positive effect on theclinical progression of Parkinson's. It is precisely here where PD 01 acts,as the vaccine triggers an effective immune response to the harmfulalpha-syn, as a result of which the body's own immune system reduces thealpha-syn. AFFiRiS is now able to announce the successful outcome of thepreclinical phase confirming the effectiveness of this principle.

To quote Dr Frank Mattner, CSO: "Alpha-syn is an attractive target fortreating Parkinson's causally and not just symptomatically. However, it mustbe remembered that alpha-syn is an endogenous protein belonging to a familyof proteins whose members have extensive sequence homologies. For example, asa so-called neuroprotective factor, the member of this protein family knownas beta-syn is important for a healthy body. A vaccination aimed at reducingalpha-syn must therefore ensure that the triggered antibody immune responseexclusively addresses alpha-syn, but leaves beta-syn untouched. OurAFFITOM(R) technology allows us to develop vaccines that guarantee this highlevel of specificity to alpha-syn. During 2010 we will complete thepreliminary work for the clinical trial".

On the basis of this technology AFFiRiS AG has already announced thedevelopment of two vaccines for Alzheimer's, one for atherosclerosis and asrecently published a vaccine against hypertension; that is to say conditionsthat affect hundreds of millions of people. Indeed, the commercialsignificance of the AFFITOM(R) technology has also been recognised by thepharmaceutical industry and by 2008 a technology licence based on this with atotal value of up to 430 million Euros was granted to GSK Biologicals for thedevelopment of the Alzheimer's vaccines.

About AFFiRiS AG (date March 2010):

On the basis of the company's own patent positions AFFiRiS developstailor-made peptide vaccines for Alzheimer's disease, atherosclerosis,Parkinson's disease and four other conditions for which there are urgentmedical needs and attractive market volumes. Alzheimer's is the currentprimary indication, and two potential products have just completed theirclinical phase I studies. For the Alzheimer's vaccine GlaxoSmithKline becamea licence partner in October 2008. The contract envisages (milestone-dependent) payments of up to 430 million Euros. A payment of 10million Euros was made in October 2009 as a result of the positive completionof two clinical phase I studies. AFFiRiS currently employs 65highly-qualified staff at the St Marx campus premises in Vienna, Austria( AFFiRiS AG: Mag. Agnes Meyer Karl-Farkas-Gasse 22 1030 Vienna T +43-1-798-15-75-390 Email W Copy Editing & Distribution: PR&D - Public Relations for Research & Education Campus Vienna Biocenter 2 1030 Vienna T +43-1-505-70-44 Email W


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