Date: 2014-07-31
Type of information: Results
phase: 1
Announcement: results
Company: Affiris (Austria)
Product: PD01A
Action
mechanism: The vaccine called PD01A is directed against alpha-Synuclein (alpha-syn), a protein considered causing the onset and progression of the disease. The vaccination aims to educate the immune system to generate antibodies directed against alpha-syn.
Disease: Parkinson's disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country: Austria
Trial
details: The trial has been conducted at the Confraternität Privatklinik Josefstadt in Vienna. PD01A was applied at two different doses (15 µg and 75 µg) to 12 patients per group. All received four vaccinations in monthly intervals, and all completed the study. Eight patients on best medical care, including standard symptomatic medication, served as a control group. Each patient was regularly seen and evaluated during a 12-month period.
Latest
news: * On July 31, 2014, Affiris announced results of AFF008, a Phase I clinical trial of PD01A, a vaccine against Parkinson’s disease. PD01A is the first therapy against the protein alpha-synuclein to enter clinical testing. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) supported the study with a $ 1.5 million grant. The Foundation will support a follow-up study testing a boost vaccination, the next step toward a Phase II trial. In this study, two different doses of PD01A were safe and well tolerated, meeting the primary endpoint of the trial. Secondary endpoints of the study included the induction of an alpha-synuclein-specific antibody response. A hallmark pathology of Parkinson’s disease is aggregates of protein — chiefly alpha-synuclein — called Lewy bodies that accummulate in brain cells, leading to cell degeneration and cell death. Researchers hypothesize that reducing alpha-synuclein accumulation will be neuroprotective; AFFiRiS is using active immunotherapy to test that theory and develop a disease-modifying treatment. Fifty percent of the vaccinated patients generated alpha-synuclein-specific antibodies as measured in serum samples. Additionally, vaccine-induced antibodies were detectable in cerebrospinal fluid. This induction of antibodies against alpha-synuclein is strong preliminary evidence in support of the principle of AFFiRiS' proprietary therapeutic vaccine. Furthermore, analysis of clinical endpoints revealed a trend, consistent over all parameters, towards functional stabilization of the vaccinated groups as compared to non-vaccinated control patients. The pharmacodynamic profile of PD01A and its clinical effects will be the basis of later phase studies, should development continue. The next study will take place in Vienna, Austria and focus on assessing the immunological and clinical effects of a boost vaccination. Recruitment is expected to begin in September. * On June 5, 2012, Affiris has announced the start of the Phase I study of its Parkinson’s vaccine candidate PD01A. This vaccine represents the first agent worldwide aiming disease modification of Parkinson’s rather than addressing symptomatic improvement only. PD01A targets a protein called alpha-Synuclein (alpha-syn) which plays a key role in the onset and progression of Parkinsons. The vaccination aims to educate the immune system to generate antibodies directed against alpha-syn.
