Ceregene enrolls for Ph II CERE-120 trial

California, USA-based Ceregene has said that enrollment is well under way in its randomized, controlled, double-blind, Phase II clinical trial evaluating CERE-120, a gene therapy product in development for the treatment of Parkinson's disease. This follows positive results from a Phase I study of the compound in 12 patients in which preliminary data showed the treatment to be well-tolerated and to provide a 35%-40 % (p<0.001) reduction in Parkinson's symptoms at six through 12 months post treatment. The complete data set from the Phase I trial will be presented at the American Academy of Neurological Surgeons Meeting on April 16.

The Phase II trial is now enrolling 51 patients with advanced PD at nine medical centers in the USA, with two-thirds of the subjects in the active treatment group and one-third in the control arm. Patients will receive CERE-120 via stereotactic neurosurgery to deliver the drug into their putamen-a region of the brain affected by the degeneration of neurons in PD. They will be followed for 12 months for safety and efficacy.

"Patients in the advanced stage of Parkinson's disease begin to run out of effective therapeutic options, and CERE-120 may have the ability to alleviate this great unmet medical need-especially given its potential to offer measurable and lasting benefit after just a single treatment," said William Marks, principal investigator for the Phase I trial and associate professor of neurology at the University of California, San Francisco.