The Phase I trial was an open-label study conducted in 12 patients with advanced Parkinson’s disease at two clinical trial sites. It was previously reported that an average of 36% reduction in Parkinson’s symptoms was seen 12 months after CERE-120 administration. Of the 12 subjects treated, nine had shown a clinically meaningful reduction in symptoms at 12 months, and the mean improvement of these responders at 12 months was 46%.
The data showed that the eight evaluable responders exhibited a persistent mean improvement in symptoms of 52% at their longest time of follow-up (24 months for low-dose cohort and 18 months for high-dose cohort).
Jeffrey Ostrove, president and CEO of Ceregene, said: “We are pleased to see that the statistically significant improvement in motor symptoms seen in the Parkinson’s patients 12 months after CERE-120 treatment appears to be persisting over longer time points. These positive clinical data offer further support for our recently enrolled multicenter Phase II trial for CERE-120 in the US as well as our plans to initiate another Phase II trial that will begin in the Q3 of 2008 which will be conducted in several European countries in collaboration with Genzyme.”