Neurologix completes all surgical procedures in Phase II Parkinson's disease study
3 December 2009 - US clinical-stage biotechnology company Neurologix Inc (OTC: NRGX) said today it has completed all planned surgeries in an ongoing Phase II study of its gene transfer approach to the treatment of advanced Parkinson's disease.
The controlled, double-blind, 44-patient Phase II trial is investigating the safety and efficacy of a novel non-dopamine approach to restore motor function in Parkinson's patients who are sub-optimally responsive to available drug therapy. The company expects to announce initial efficacy results from the trial in mid-2010.
The investigators are assessing each of the trial participants over time for treatment effects, with the primary trial endpoint being a clinical assessment of motor function at 6 months using the Unified Parkinson's Disease Rating Scale (UPDRS). All participants in the trial will also be monitored for safety for 12 months following their gene transfer procedure.