VIENNA, Austria—AFFiRiS AG has announced the initiation ofthe first worldwide clinical trial for the development of its Parkinson'svaccine, PD01A. The vaccine targets alpha-Synuclein, a protein believed to bethe cause of the onset and progression of Parkinson's, and is being tested in aPhase I trial. Thetrial, which consists of 32 patients, will focus on the safety and tolerabilityof PD01A as its primary endpoints.
"Worldwide, for the first time immunotherapy is applied forthe treatment of Parkinson's. It is a so-called "First-in-Man" and"First-in-Kind" trial, because PD01A is the first medication worldwide aimingfor clinical efficacy by modulating the metabolic pathway of alpha-syn," Dr.Walter Schmidt, CEO of AFFiRiS, said in a press release regarding the trial'skickoff.
In addition to targeting alpha-Synuclein, the vaccine alsoseeks to train the immune system to generate antibodies against the protein.PD01A represents the first compound that could potentially treat the cause ofParkinson's rather than just taking a symptom-relief approach. Essentially alltherapeutics for the disease are based on increasing the amount of dopamine inthe brain in hopes of offsetting the symptoms. But that targets only theresults, not the cause of the disease, which is credited to deposits ofpathological forms of alpha-Synuclein in the brain. It is believed thatreducing the alpha-Synuclein aggregates in the brains of Parkinson's patientswill be beneficial in reducing the progression of the disease, which willhopefully be enacted by PD01A training the bodies to produce antibodies againstthe protein.
"PD01A is based on our AFFITOME-technology, which alreadyidentified our lead vaccine developments in the field of Alzheimer's. Thistechnology delivers not only a single vaccine for the treatment of a certaindisease but a whole pool of product candidates with excellent safety profilesand exactly fine-tuned specificities," Dr. Frank Mattner, CSO of AFFiRiS, saidin a press release. "Therefore, we apply our strategy of "clinical maturation",meaning that we investigate several vaccines against a certain disease inclinical testing to ensure that the best vaccine for humans will be developed."
The Michael J. Fox Foundation, which has financially supported the development of PD01A, notes that one in 100 peopleover the age of 60 are affected by Parkinson's, with an estimated one millionpeople in the United States and more than five million worldwide suffering fromthe disease.
SOURCE: AFFiRiS AG press release