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Novel Gene Therapy Agent NLX-P101 Effective in Treating Parkinson's Disease in Phase 2 Trial
Date:3/16/2011

FORT LEE, N.J., March 16, 2011 /PRNewswire/ -- Neurologix, Inc. (OTC Bulletin Board: NRGX), announced today that the results of the Company's Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD) were published in an online-first edition of The Lancet Neurology. The randomized, double-blind, sham surgery-controlled trial of 45 subjects with advanced PD met its primary outcome measurement for efficacy and demonstrated that NLX-P101 gene therapy was safe and well-tolerated over the six month blinded study period.

Study results show that NLX-P101 treatment led to a mean 23.1 percent improvement (8.1 points) in off-medication Unified PD Rating Scale (UPDRS) motor score at the six-month study end-point, compared to a mean 12.7 percent (4.7 points) improvement with sham treatment. Improved motor control in the NLX-P101 group was seen at one month and continued virtually unchanged throughout the blinded study period.  The improvement in UPDRS motor scores from baseline in the NLX-P101 group was significantly greater than sham subjects over the six month study period (p=0.04).

Study results also show that 50% of subjects treated with NLX-P101 achieved previously defined moderate-to-large clinically-meaningful symptom improvements (> / = 9 points in UPDRS), compared to just 14% of subjects who received a sham surgical treatment (p=0.03). No serious adverse events (SAEs) related to the gene therapy or surgical procedure were reported.

"This is the first Phase 2 study conducted under a rigorous randomized, double-blind, sham-controlled surgical design to conclusively demonstrate that gene therapy can be effective for neurological diseases. This confirms our Phase I results and indicates that NLX-P101 may provide a safe, effective and minimally invasive treatment option for patients with PD
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SOURCE Neurologix, Inc.
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