Austria-based vaccinemaker Affiris announced that its Parkinson's disease vaccine has met its primary endpoint in a small Phase I safety trial of patients receiving two different doses of the jab.
Parkinson's has proven to be a huge clinical challenge because of the lack of understanding surrounding the disease. Though Affiris has been operating under a virtual cloud since it claimed a dubious breakthrough in Alzheimer's back in June, the company thinks its vaccine PD01A holds promise in patients with the debilitating condition.
In the study, PD01A was administered at two different doses, 0.015 milligrams (15 micrograms) and 0.075 milligrams (75 micrograms) to two groups of patients. Affiris reported that both doses were safe and well tolerated. Each 12-patient group received four vaccinations at monthly intervals.
PD01A targets the protein alpha-synuclein, a promising target that's been the focus of Parkinson's disease research in recent years. Of the patients that were vaccinated, 50% generated alpha-synuclein-specific antibodies as measured in serum samples. Aggregates of alpha-synuclein, or Lewy bodies, in brain cells are a hallmark of Parkinson's disease.
Affiris presented the findings from the Phase I clinical trial at a press conference in New York on July 31. The Michael J. Fox Foundation, which supported the Phase I trial with a $1.5 million grant, said it will support a follow-up study testing a boost vaccination, the company's next step toward bringing the vaccine to a Phase II trial.
"A treatment that could slow or stop Parkinson's progression would be a game changer for the 5 million worldwide living with this disease and the many more who will become at risk as our population ages," said the Michael J. Fox Foundation's CEO Todd Sherer in a statement.
The next steps will take place in Vienna, and the company expects to begin recruitment for the trials in September. Affiris said the clinical testing will focus on assessing the immunological and clinical effects of a boost vaccination.
"The safety and tolerability observed in this study, especially in a protein such as alpha-synuclein where we do not yet know its normal function, are encouraging," Affiris CEO Walter Schmidt said in a statement.
- here's the company's release