AFFiRiS: Parkinson`s Vaccine - worldwide first clinical study in Vienna

Affiris, Vienna, 5 June 2012 - 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 Confraternität 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®-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,

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