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Neurologix Presents One-Year Follow-Up Data From Phase 2 Study of NLX-P101 in Parkinson's Disease at International Neuromodulation Society 10th World Congress
Date:5/26/2011

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"The results presented today at the INS World Congress add to a growing body of clinical evidence demonstrating that our novel gene therapy approach may provide significant clinical benefits to Parkinson's disease patients," During added. "In the treatment arm of the Phase 2 study, improved motor control was seen at one month, continued virtually unchanged throughout the six-month blinded study period and persisted through 12 months of follow-up. This suggests that the treatment effect from NLX-P101 is meaningful and durable over the long-term."

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 subt
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SOURCE Neurologix, Inc.
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