In recent years, so many diseases are known to be the ones that can trigger the Parkinson’s Disease, which is a degenerative disorder that affects the CNS. It can be chronic, and during the last years, the symptoms can be worst. The nervous cells die, mainly affecting the natural movement, leading to tremors, rigidity in the limbs or trunk, or balance problems. Until recent years, there were only palliative treatments.
It was not until 2012 that the biotechnology company named as AFFiRiS AG, brought on a new solution for the Parkinson’s disease. They created a vaccine (PD01A) that is capable to generate antibodies against the alpha-synuclein protein, which has been strongly associated to generate death in nervous cells, leading to symptoms and progression of Parkinson’s disease. The treatment works the same way as any vaccine against flu, creating antibodies that can help to attack the disease without the prolonged use of medicines. In order to bring this medicine into the market, they needed to test it in humans.
That’s why they created the boost study, that consists on a first Clinical trial supported by MJFF (The Michael J. Fox Foundation), in which 24 subjects that were in early stages of Parkinson’s disease, received 4 doses of PD01A. Apparently, this trial proved that the treatment was not only safe, also, that half of all the subjects were capable to generate those antibodies. However, after one year, investigators saw that their antibody levels against the alpha-synuclein protein were lower. Therefore, this trial gave to each participant a new dose a year later, just to see if the “impulse” would be safe and could elevate again the antibody levels. At the end of the trial, the results showed two important facts: all the subjects completed the trial because they had a benefit response to the first application and those who did not on the first one developed those antibodies on the second one.
This was and will be the first basis to create new approaches to treat this dangerous disease. Without any safety treatment and/or knowledge about the main cause that can trigger it, it is difficult to determinate which factors can be avoided. Despite of some cases that seem to have hereditary origin, it shouldn’t be a death warrant.
This clinical trial demonstrates how important it is to generate efficacy and accurate data. It could seem an easy clinical trial due to the lack of more than two treatments; however, it is important to do the follows up, performed any test needed on time, report any event within the first 24 hours, and know what to do in case any subject doesn’t tolerate the investigational product. We are aware about the importance that has reporting all the information to the pharmaceutic company without neglecting the patient. Contact us and we will be more than happy to help you to have a successfully and viable clinical trial.