** Fox Feed Blog September 2016**

New study results from Austrian biotech AFFiRiS support continued development of its vaccine against the key Parkinson's protein alpha-synuclein. The company announced its "boost" follow-up study -- funded with a $1.04 million grant from The Michael J. Fox Foundation -- showed that an additional dose is safe and can elicit antibodies against alpha-synuclein. 

Researchers believe that clumps of this protein (also called fibrils) are toxic and cause the cell death that leads to Parkinson's disease (PD) symptoms and progression.

AFFiRiS has developed a vaccine (called PD01A) to cause the body's immune system to create antibodies against alpha-synuclein, hopefully clearing out the clumps and protecting neuron cells. The treatment works much like the flu vaccine, activating the body to create its own natural disease fighters.

The "boost" study builds on a first clinical trial, also funded by MJFF, where 24 participants with early-stage Parkinson's received four doses of PD01A. That trial proved the treatment was safe and showed that half of the participants created alpha-synuclein antibodies. Within a year, however, each of the "responders" saw their levels of alpha-synuclein antibodies decline. This follow-up trial gave each participant one more dose a year later to see if a "boost" would be safe and would raise antibody levels again. AFFiRiS reported that the trial was safe; all 28 participants (22 from the first trial and six other people with PD) completed the study. In addition, more volunteers (86 percent) saw an antibody response. All responders from the first trial responded again, and some who did not respond in the first trial produced antibodies with the boost.

This showed that the body is not desensitised to the vaccine and can produce alpha-synuclein antibodies again, and that you don't have only one opportunity for treatment - that if you don't produce antibodies with a first round of vaccine, you may with follow-up.

Kuldip Dave, PhD, MJFF director of research programs who directs the MJFF alpha-synuclein portfolio

These initial results are positive and although there are still questions to be answered concerning some of the data, MJFF are confident that future trials may explore who would be a good candidate for a therapy such as PD01A - laboratory tests showed that PD01A-induced antibodies did bind to alpha-synuclein fibrils, the type thought to be toxic and associated with PD. 

A second follow-up study ("reboost") is ongoing, funded by MJFF, to monitor the participants and give another dose when their antibody levels start to fall. Many (42 percent) of antibody responders from the first trial did not need to increase their dopamine medication over the study observation period (an average of three years). Future studies will be designed to assess efficacy.

Read the Full Article here - published in Michael J Fox 'Fox Feed Blog' Posted by Maggie McGuire Kuhl, September 07, 2016