The vaccine, called AFFITOPE® PD03A , targets a protein called alpha-Synuclein. The protein plays a key role in the onset and progression of Parkinson's as well as multiple system atrophy (MSA), an orphan disease. This vaccine has the potential to modify disease progression, rather than only symptomatic improvements available with current treatment strategies.
Current scientific understanding is that Parkinson's – as well as MSA – is caused by deposits of pathological forms of alpha-Synuclein in the nervous system. The reduction of pathological alpha-Synuclein levels is believed to have a beneficial impact on the progress of the diseases. PD03A aims to accomplish this by inducing the production of antibodies that target and promote clearance of alpha-Synuclein in order to neutralize its toxic impact.
Recruitment is being done by the EU-consortium SYMPATH. AFFiRiS AG recently had encouraging clinical results of a Parkinson's trial of one of its other vaccines, namely PD01A, which confirmed the safety and tolerability of the vaccine, as well as its ability to induce an immune response and even achieve functional stabilization.
Commenting on the latest clinical trial, Prof. Achim Schneeberger, Chief Medical Officer at AFFiRiS and coordinator of SYMPATH, explains, "The results we achieved with the Parkinson's vaccine PD01A were very encouraging. Now, PD03A will be tested in a comparable setting and we are eagerly awaiting the results. "The current trial of PD03A is a multi-centric patient blinded, randomized, placebo-controlled, parallel group Phase I trial. It will be conducted in Vienna and Innsbruck, Austria. Prof. Werner Poewe, chairman of the Department of Neurology at the Medical University of Innsbruck and principal investigator of the study, explains the objectives of the trial: "The primary endpoint of the trial aims to demonstrate the safety and tolerability of the vaccine. It will also assess the vaccine's immunological and clinical activity in vaccinated patients as its secondary endpoint."
Dr. Dieter Volc of PROSENEX Ambulatorium BetriebsgmbH, leading the trial in Vienna, adds, "PD03A is one of the first medications worldwide aiming for clinical efficacy by modulating the metabolic pathway of alpha-Synuclein. It has the potential to treat the cause of Parkinson's – not just the symptoms."
The project partners are:
AFFiRiS AG (Austria) – Prof. Dr. Achim Schneeberger
Biolution GmbH (Austria) – Dr. Iris Grünert
University Hospital Bordeaux (France) – Prof. Wassilios Meissner, MD
INSERM F-CRIN Toulouse (France) – Claire Levy Marchal, MD, MSc
Prosenex Ambulatoriumsbetriebs-GmbH (Austria) – Dieter VOLC, MD
Medical University Innsbruck, Department of Neurology (Austria) – Prof. Werner Poewe, MD&Prof. Klaus Seppi, MD
Forschungszentrum Jülich GmbH (Germany) – Prof. Dr. Dieter Willbold
University Hospital Toulouse (France) – Prof. Olivier Rascol, MD
Source: AFFiRiS AG