PD01 is designed to trigger antibodies that bind to and clear alpha-synuclein from the brain.

AFFiRiS was awarded $1.5 million from the Michael J. Fox Foundation (MJFF) to support a Phase I study with its Parkinson disease (PD) vaccine, PD01. Preclinical studies indicate PD01 stimulates the production of antibodies that bind to alpha-synuclein and clear it from the brain, preventing the formation of alpha-synuclein Lewy bodies and slowing disease progression.

“PD01 represents the first time a vaccine approach to Parkinson disease has been studied in the clinic,” comments Todd Sherer, Ph.D., MJFF’s CEO. “While it is still in the early stages of testing, its potential to stop the progression of the disease itself could lead to a breakthrough in how we treat PD.”

AFFiRiS is exploiting its Affitome® platform to develop peptide-based vaccines against a range of disease including PD and Alzheimer disease, atheroslcerosis, and hypertension. The individual vaccine antigens comprise short peptides that are unrelated to the native target or its fragments but which function as B-cell epitopes that induce targeted antibody immune responses. Importantly, the Affitome technology generates pools of potential candidates against each individual target, which improves the likelihood of clinical success.

The firm’s early clinical-stage pipeline is headed by the Alzheimer disease vaccine candidates AD01, AD02, and AD03. AD01 und AD02 have successfully completed Phase I studies, and AD03 is now undergoing Phase I evaluation. In the second half of 2010 AFFiRiS initiated a Phase II efficacy study with AD02. The multicenter, 12-month European trial will evaluate repeated AD02 vaccinations in 420 patients with early Alzheimer’s disease.

Today’s grant is the second awarded by MJFF to Austrian research teams. Besides AFFiRiS, the foundation is also supporting investigators in Innsbruck, which is part of a consortium including 21 clinical sites involved in the Parkinson’s Progression Markers Initiative.

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