The phase I trial was conducted in 12 patients who underwent stereotactic neurosurgery to deliver the product, CERE-120, into their putamen, a region of the brain affected by the degeneration of neurons in Parkinson’s disease.
This 36% improvement was maintained in both groups at the 12-month mark, the final follow-up time point in the study. Patients also demonstrated a 50% reduction in hours of “off” time, which is a time when normal Parkinson’s medication is ineffective and symptoms are troubling to the patient. Patients also experienced a doubling of good quality “on” time without dyskinesias, which is when a patient is functioning well. CERE-120 was also shown to be well tolerated in this study.
“Given the encouraging data from the phase I trial of CERE-120 in Parkinson’s disease, we are conducting a follow-on phase II clinical trial that is currently enrolling patients at nine clinical trial sites in the US,” said Raymond Bartus, Ceregene’s COO and senior vice president of clinical and preclinical R&D.
“The data from the phase I trial are reflective of the impressive results we gathered from preclinical studies, which demonstrated the ability of CERE-120 to stimulate the survival and improve the function of key neuronal cells affected by Parkinson’s disease, as well as an excellent safety profile over a wide range of CERE-120 dose levels.”