NeuroCell-PD fails in Phase II
Genzyme (GENZ) and partner Diacrin (DCRN) said preliminary analysis of a U.S. Phase II trial in 18 patients with severe Parkinson's disease showed NeuroCell-PD porcine neural cell transplant did not meet its primary end point, a difference in score on the Unified Parkinson's Disease Rating Scale between treated and control groups 18 months after surgery. The double-blind, placebo-controlled trial showed improvement in both groups. There also were no significant differences on secondary end points of motor skills, investigator global evaluations, and percentage of waking hours spent in the "off" state or 12 hours after last medication. However, at 12 months the treated group did show a reduction in the percentage of waking hours spent with dyskinesias compared to controls. GENZ said it plans to complete the analysis of the Phase II data and decide whether to proceed with additional clinical studies. ...