Objective/Rationale:
Parkinson’s disease (PD) is characterized by the formation of abnormal alpha-synuclein accumulations, so called Lewy bodies, in the nervous system. Alpha-synuclein is currently believed to be central to the disease process underlying PD. Hence it is assumed that a reduction in cerebral alpha-synuclein has a beneficial effect on disease progression. Consequently, this project aims at developing the AFFITOPE® vaccine PD01 as a safe and efficacious PD vaccine directed against alpha-synuclein which could provide a novel treatment strategy against PD.
Project Description:
The novel anti alpha-synuclein vaccine PD01, identified by the AFFiRiS’ AFFITOME® technology, already demonstrated reduction of alpha-synuclein levels and associated pathological alterations in an pre-clinical model for PD. In the course of this project we will be further evaluating the effects of PD01 within a defined pre-clinical screening program in pre-clinical models. This screening will include the assessment of immunogenicity, stability and safety as well as efficacy of this vaccine to reduce PD-like pathology in the models used. The effects detectable will be compared to previous results obtained with PD01 at AFFiRiS in order to get additional efficacy and safety information for the active vaccination strategy applying the AFFITOPE® concept.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
The pre-clinical evaluation of the AFFITOPE PD01 will be a first step in the further development of PD vaccines as novel treatment strategy for PD. After the vaccine candidate PD01 has proven its efficacy in our models an initial clinical trial will be initiated. This clinical evaluation of safety and tolerability of the PD vaccine will shed light on the applicability of PD-vaccines in human patients with its potential to alter the clinical progression of Parkinson’s.
Anticipated Outcome:
The pre-clinical evaluation of the AFFITOPE PD01 in reducing PD-like pathology and functional decline in the pre-clinical model used will lead to new results and insight into the etiology of PD-like pathology in pre-clinical models. In addition this analysis will be designed in order to further elucidate the mechanism of action of active immunotherapy directed against alpha-synuclein to better understand the basic mechanisms underlying immunotherapy in pre-clinical models of PD.