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news.Neurologix, a biotechnology company, has initiated its Phase II clinical trial for the treatment of advanced Parkinson's disease. The first trial participants have undergone surgery at multiple institutions and additional subjects are currently being enrolled.
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The purpose of the trial is to validate the safety and efficacy of Neurologix’s gene transfer therapy, a novel non-dopaminergic approach to restore motor function in Parkinson’s patients who are sub-optimally responsive to available drug therapy.
Trial participants will be assessed for treatment effects by standardized Parkinson’s disease ratings at multiple time points post-procedure. The primary endpoint for the trial will be a clinical assessment of motor function at six 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 the gene transfer procedure. If the primary endpoint is met following the analysis of six month data, then the sham-control participants will be offered the opportunity to crossover into an open label study of the Neurologix gene transfer therapy if they continue to meet all entry, medical and surgical criteria.
John Mordock, president and CEO of Neurologix, said: Initiating this Phase II clinical trial represents a significant milestone. We expect to enroll 40 subjects across six to eight US academic research centers, with completion of enrollment expected during the second half of 2009.