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Neurologix Presents New Confirmatory Results for Phase 2 Study of NLX-P101 in Parkinson's Disease to Recombinant DNA Advisory Committee
Date:6/8/2011

tion against Parkinson's. We look forward to the opportunity to conduct Phase 3 testing, with the goal to bring NLX-P101 to the market for patients in urgent need of a new treatment option."

Drs. During and Kaplitt have been at the forefront of gene therapy research since 1989 and the Phase 2 trial was the culmination of nearly 20 years of progress with their work in gene transfer technology using an adeno-associated virus (AAV) vector (a disabled, non-pathogenic virus). They were the first to demonstrate that AAV could be an effective gene therapy agent in the brain, which they reported in their landmark Nature Genetics paper in 1994. Drs. During, Kaplitt and colleagues subsequently published additional research demonstrating the beneficial effects of AAV-GAD gene therapy for PD in the journal Science in 2002.

About the Phase 2 Study

The trial involved 45 subjects with moderate to advanced PD who were not adequately controlled with current therapies. Medical centers that participated in the study included: Henry Ford Health System; Massachusetts General Hospital; Stanford University School of Medicine; The Feinstein Institute for Medical Research of the North Shore-LIJ Health System; The Ohio State University College of Medicine; University of Colorado School of Medicine; University of Rochester School of Medicine; and Wake Forest University School of Medicine.

Study subjects were randomized to receive either NLX-P101 treatment or sham surgery. Subjects in the NLX-P101 treatment arm received infusions of the genetic material directly into bilateral subthalamic nuclei (STN), a key brain region involved in motor function. Sham-assigned subjects underwent simulation of a bilateral neurosurgical procedure. At the end of each procedure, infusion catheters were removed at the bedside and nothing was left in the brain. All procedures were performed under local anesthesia. All but one of the trial participants were discharg
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SOURCE Neurologix, Inc.
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