Individuals with Parkinson’s disease may have a new treatment option in the near future. Austrian biotech company AFFiRiS AG has begun testing a new Parkinson’s vaccine in a clinical Phase I trial in Austria by an EU-funded consortium.
Parkinson’s disease is a degenerative disorder of the central nervous system in which the brain cells that produce dopamine slowly die. Dopamine helps control muscle movement. Symptoms of Parkinson’s disease include shaking, rigidity, slowness of movement, and difficulty with walking and gait.
The new vaccine targets a protein called alpha-Synuclein, which plays a key role in the onset and progression of Parkinson’s disease. Unlike current treatments that provide only symptomatic improvements of the severe motor symptoms of the disease such as tremor, the vaccine may modify disease progression.
Today the EU-consortium SYMPATH starts recruitment for a Phase I study of a Parkinson’s disease vaccine candidate called AFFITOPE® PD03A that will be conducted in Vienna and Innsbruck, Austria. The trial a multi-centric patient blinded, randomized, placebo-controlled, parallel group Phase I trial that begins after a similar Parkinson’s vaccine trial recently conducted by AFFiRiS with support from the Michael J. Fox Foundation produced positive results.
Comments Professor Achim Schneeberger, Chief Medical Officer at AFFiRiS and coordinator of SYMPATH:
“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.”
Explains Professor Werner Poewe, chairman of the Department of Neurology at the Medical University of Innsbruck and principal investigator of the study, about 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.”
Adds Dr. Dieter Volc of PROSENEX Ambulatorium BetriebsgmbH:
“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.”
Current understanding of Parkinson’s is that deposits of pathological forms of alpha-Synuclein in the nervous system cause the disease. Researchers believe that a reduction of pathological alpha-Synuclein levels may have a beneficial effect on the progression of the disease. The vaccine PD03A aims to cause the reduction by inducing the production of antibodies that target and promote clearance of alpha-Synuclein in order to neutralize the toxic impact.
Concludes Dr. Markus Mandler, head of the Neurodegeneration Department at AFFiRiS explains:
“Both vaccines are based on AFFiRiS’ AFFITOME®technology. 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 strong specificity to their targets.”
Parkinson’s disease: http://www.mayoclinic.org/diseases-conditions/parkinsons-disease/basics/definition/con-20028488
Parkinson’s disease: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001762/
Parkinson’s vaccine tested on first patients: http://www.medicalnewstoday.com/releases/286734.php
Intramuscular Injection: http://www.freeimages.com/photo/818504