News Feature | December 15, 2014

New Parkinson's Vaccine Enters Clinical Trial In Europe

By C. Rajan, contributing writer

Austrian biotech company, AFFiRiS AG, has announced that a novel Parkinson's vaccine candidate, AFFITOPE PD03A, will be tested in a Phase 1 clinical trial in Austria soon. The trial will be conducted by the newly launched EU-funded consortium, SYMPATH, which is now recruiting patients for the trial.

This vaccine candidate targets a protein called alpha-Synuclein, which plays a key role in the onset and progression of Parkinson's. AFFITOPE PD03A aims to slow down the disease progression, rather than just provide symptomatic improvements like current treatment strategies.

This new Parkinson's trial follows the recent successful trial of the company’s other Parkinson's vaccine, PD01A. This similar vaccine was evaluated in a Phase 1 trial with support from the Michael J. Fox Foundation, and demonstrated good safety and tolerability, as well as the ability to induce an immune response and achieve functional stabilization.

Both the vaccines are based on AFFiRiS' affitome technology, which is capable of delivering a pool of highly specific vaccine product candidates for the treatment of a certain disease, says the company. The two vaccine candidates aim to modify the disease rather than just ameliorate the severe motor symptoms of the disease.

Prof. Achim Schneeberger, CMO 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 new Phase 1 trial of PD03A will be a multi-center, blind, randomized, placebo-controlled study conducted in Vienna and Innsbruck, Austria. The primary endpoints of the trial will be safety and tolerability, while the vaccine's immunological and clinical activity in vaccinated patients will be the secondary endpoint.

A progressive and debilitating neurodegenerative disease among the elderly, Parkinson's is believed to be caused by deposits of pathological forms of the alpha-Synuclein protein in the nervous system. The PD03A vaccine candidate works by inducing the production of antibodies that target and promote clearance of alpha-Synuclein from the nervous system. By thus reducing the levels of the alpha-Synuclein protein, the vaccine will have a beneficial impact on the progress of the disease.

Dr. Dieter Volc, who will be leading the clinical trial in Vienna, says, "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."