Date: 2014-12-09
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: EU-consortium SYMPATH (AFFiRiS AG (Austria), Biolution GmbH (Austria), University Hospital Bordeaux (France), INSERM F-CRIN Toulouse (France), Prosenex Ambulatorium Betriebs-GmbH (Austria), Medical University Innsbruck, Department of Neurology (Austria), Forschungszentrum Jülich GmbH (Germany),University Hospital Toulouse (France) )
Product: AFFITOPE® PD03A
Action
mechanism: AFFITOPE® PD03A is one out of a designated pool of 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). 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.
Disease: Parkinson\'s disease
Therapeutic area: Neurodegenerative diseases
Country: Austria
Trial
details: Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinson\'s disease. In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved. AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).(NCT02267434)
Latest
news: * On December 9, 2014, Affiris announced that a novel Parkinson\'s vaccine will now be tested in a clinical Phase I trial in Austria by the EU-funded SYMPATH consortium. The vaccine was developed by Affiris and 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. The start of the Parkinson\'s trial follows in the wake of positive results from a similar Parkinson\'s vaccine trial recently conducted by Affiris with support from the Michael J. Fox Foundation. The EU-consortium SYMPATH is starting recruitment for a Phase I study of Affitope® PD03A. 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.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.
