AFFiRiS AG has started the first ever Phase I clinical trial for the development of a Parkinson's vaccine (PD01A) at the Confraternit?t Privatklinik Josefstadt in Vienna. This is the first time a vaccine has the potential to treat the cause of Parkinson's.
The study, supported generously by the US-American Michael J. Fox Foundation, will test PD01A on up to 32 patients with Parkinson's disease. The primary endpoints of the trial are safety and tolerability of PD01A.
PD01A is the first vaccine in the world designed to treat Parkinson's rather than improve symptoms of the disease. The vaccine targets a protein called alpha-Synuclein (alpha-syn) which plays a vital role in the onset and progression of Parkinson's. The aim of the vaccine is to instruct the immune system to produce antibodies directed against alpha-syn.
Dr. Walter Schmidt, CEO of AFFiRiS, explained:
"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 states 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."
Although there are medications that impact the symptoms of Parkinson's, none of them are able to modify the course of the disease, thus making PD01A the first potential vaccine to treat the cause of Parkinson's.
Parkinson's is believed to be caused by deposits of pathological forms of alpha-syn in the brain. Reducing the alpha-syns in the brain is thought to have a beneficial affect 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, said:
"PD01A is based on our AFFITOMEŽ-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."