Clinical Development
In 2003, an initial study, in humans, was undertaken at the University Department of Clinical Neurology at the Radcliffe Infirmary in Oxford. AIMSPRO was found to be well tolerated and there were no serious adverse events. This study was exploratory and only measured immediate change after three treatment doses. The results were deemed to be encouraging and supported the need for further clinical trials.
A second trial was started at The St George's Hospital in London but unfortunately it was never completed and had to be halted at the manufacturer's request. Importantly though, AIMSPRO was found to be well tolerated and there were no serious adverse events reported. The results from these studies and further laboratory studies taking place in parallel led to the identification of specific molecular species in the product and specific correlating responses in the patients. After a period Daval embarked on a further fully powered clinical trial in Secondary Progressive MS and a new study in Scleroderma.