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Early Trial Shows Parkinson’s Vaccine Creates Antibodies

Alpha-synuclein illustration

Alpha-synuclein illustration (Michael J. Fox Foundation)

31 July 2014. An early-stage clinical trial testing the safety of an experimental vaccine to treat Parkinson’s disease, shows the vaccine generates antibodies that fight the build-up of proteins in the brain associated with the disorder. The vaccine is made by the biotechnology company Affiris AG, which presented the results today at a press conference in New York with the Michael J. Fox Foundation that funds the vaccine’s early clinical trials.

Affiris, in Vienna, Austria, develops vaccine therapies with a technology based on peptides called epitopes, areas on molecules to which antibodies bind. The epitopes in Affiris vaccines connect to B-cells, white blood cells programmed to generate antibodies addressing a specific target.

That target in this case is alpha-synuclein proteins, the build-up of which in the brain are a pathology associated with Parkinson’s disease, a neurodegenerative disorder. The disease is believed to result from the loss of cells in the brain that produce dopamine, a chemical that helps control movement.

The build up of alpha-synuclein proteins are believed to damage neurons, or nerve cells in the brain. Affiris is developing a vaccine with the code-name PD01A that aims to control levels of alpha-synuclein in the brain, by protecting neurons from the build-up of this protein.

The clinical trial, held in Vienna, enrolled 32 patients between the ages of 40 and 65 with Parkinson’s disease, of which 12 patients each were given four injections each month of PD01A in doses of either 15 or 75 micrograms for a year. Another eight patients receiving medications to control Parkinson’s symptoms, considered the standard of care, served as a control group.

In the first results reported from the trial, Affiris says about half of the patients receiving the vaccine developed antibodies to alpha-synuclein, which the researchers found in serum samples, as well in the patients’ cerebrospinal fluid. The trial also measured changes in motor symptoms and cognition of the patients, for which the company reported more stabilization among the vaccinated patients than those not getting the vaccine. Affiris says the vaccine was safe and well-tolerated by the patients, the main measurement objective of the trial.

The company plans a follow-up study of patients receiving PD01A, checking for any adverse effects of the vaccine after another year, as well as the vaccine’s continued ability to generate antibodies and influence Parkinson’s symptoms. An intermediate-stage clinical trial is expected to begin recruitment in September.

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