AFFiRiS AG: Parkinson’s Vaccine – Worldwide First Clinical Study in Vienna

VIENNA, June 5, 2012 /PRNewswire/ –

The worldwide first clinical trial for the development of a Parkinson’s vaccine has
now been started by AFFiRiS AG. The vaccine called PD01A is directed against
alpha-Synuclein, a protein considered causing the onset and progression of the disease,
and is currently being tested on Parkinson’s patients in a Phase I trial. The vaccine
holds out the prospect to deliver a causative treatment of Parkinson’s for the first time.
Its potential for success prompted the US-American Michael J. Fox Foundation to generously
support the development of PD01A financially. Taking place in Vienna and involving up to
32 patients, the primary endpoints of the trial are safety and tolerability of PD01A.

AFFiRiS AG announced today the start of the Phase I study of its Parkinson’s vaccine
candidate PD01A. This vaccine represents the first agent worldwide aiming at disease
modification of Parkinson’s rather than addressing symptomatic improvement only. PD01A
targets a protein called alpha-Synuclein (alpha-syn) which plays a key role in the onset
and progression of Parkinson’s. The vaccination aims to educate the immune system to
generate antibodies directed against alpha-syn. The trial will be conducted at the
Confraternitat Privatklinik Josefstadt in Vienna and will involve up to 32 patients.

Dr. Walter Schmidt, CEO of AFFiRiS, comments on the progress of the Parkinson’s
project: “Worldwide, for the first time immunotherapy is applied for the treatment of
Parkinson’s. It is a so-called “First-in-Man” and “First-in-Kind” trial, because PD01A is
the first medication worldwide aiming for clinical efficacy by modulating the metabolic
pathway of alpha-syn. Even in its preliminary stages this new treatment concept was highly
appreciated, as the renowned Michael J. Fox Foundation assented financial support to a
total of USD 1.5 million. Hence, this is one of the few projects outside of the USA
considered worthy of support by the foundation.”

This recognition is remarkable as the vaccine-candidate of AFFiRiS has the potential
to treat the cause of Parkinson’s for the first time. Since the approval of L-DOPA some 50
years ago, any other therapeutic intervention followed the same concept: the substitution
of the neurotransmitter dopamine. Accordingly, all medications for Parkinson’s so far can
impact on the symptoms only, but none of them can modify the course of the disease.

Based on today’s scientific understanding, Parkinson’s is caused by deposits of
pathological forms of alpha-syn in the brain. A reduction of the brain’s alpha-syn
aggregates is believed to have a beneficial impact on the progress of the disease. PD01A
shall accomplish that upon the induction of antibodies that are targeting alpha-syn, to
neutralize its toxic impact.

Dr. Frank Mattner, CSO of AFFiRiS: “PD01A is based on our AFFITOME(R)-technology,
which already identified our lead vaccine developments in the field of Alzheimer’s. This
technology delivers not only a single vaccine for the treatment of a certain disease but a
whole pool of product candidates with excellent safety profiles and exactly fine tuned
specificities. Therefore, we apply our strategy of “clinical maturation”, meaning that we
investigate several vaccines against a certain disease in clinical testing to ensure that
the best vaccine for humans will be developed.”

About AFFiRiS AG (as of June 2012):

Based on the company’s own patent positions, AFFiRiS develops tailor-made peptide
vaccines for Alzheimer’s disease, Atherosclerosis, Parkinson’s disease, hypertension and
several other conditions with urgent requirement for new treatments and attractive market
volumes. Alzheimer’s is the current lead indication. A license and option agreement for
the Alzheimer’s vaccine programme was concluded with GlaxoSmithKline in October 2008,
triggering an up-front payment of EUR 22.5 million. The contract envisages (
milestone-dependent) payments of up to EUR 430 million. An initial milestone payment of
EUR 10 million was made in October 2009 followed by EUR 3.5 million as announced in
February 2011. AFFiRiS currently employs 85 highly-qualified staff at the Campus Vienna
Biocenter in Vienna, Austria (http://www.affiris.com).

        Contact AFFiRiS AG:
        Julia Bock
        Karl-Farkas-Gasse 22
        1030 Vienna, Austria
        T +43(0)1-798-15-75-303
        E  julia.bock@affiris.com
        W http://www.affiris.com
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        PR&D - Public Relations for Research & Education
        Mariannengasse 8
        1090 Vienna, Austria
        T +43(0)1-505-70-44
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SOURCE AFFiRiS AG