Parkinsons's vaccine: EU-team launches clinical trial

11-Dec-2014 - Austria

The EU-consortium SYMPATH starts recruitment for a Phase I study of a Parkinson's vaccine candidate called AFFITOPE® PD03A. This vaccine is one out of a designated pool of promising vaccine candidates based on AFFiRiS' proprietary AFFITOME® technology. These candidates aim at disease modification of Parkinson's instead of only ameliorating the severe motor symptoms of the disease, such as tremor. All vaccines in this pool target alpha-Synuclein, a protein that is key to the onset and the progression of both, Parkinson's and multiple system atrophy (MSA). Recently, encouraging clinical results of a Parkinson's trial of one other of the pool's vaccines, namely PD01A, were presented by the Michael J. Fox Foundation and AFFiRiS. These 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."

The start of the clinical trial comes only a year after the SYMPATH-Consortium was launched. This rapid progress is owed to the high expertise in Parkinson's and related diseases of all members of the consortium including the Forschungszentrum Jülich in Germany, the INSERM F-CRIN Toulouse, the Departments of Neurology at the University Hospitals of Bordeaux and Toulouse, France, as well as the Medical University of Innsbruck's Department of Neurology and PROSENEX, Vienna, Austria.

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