March 17, 2011
Phase 2 Study of NLX-P101 for Parkinson's DiseaseNeurologix announced results from a Phase 2 clinical trial of NLX-P101 for the treatment of Parkinson's disease. The randomized, double-blind, sham surgery-controlled trial of 45 patients with advanced Parkinson's disease showed that patients treated with NLX-P101 achieved a mean improvement of 23.1% (8.1 points) in off-medication Unified PD Rating Scale (UPDRS) motor score compared with 12.7% (4.7 points) 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 patients 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 with 14% of subjects who received a sham surgical treatment (p=0.03).
In Parkinson's disease, the loss of dopamine-secreting neurons alters chemical signaling pathways in the brain that affect neurotransmitter input to the bilateral subthalamic nuclei (STN), a key brain region involved in motor function. NLX-P101 modulates the activity of the STN, which is overactive in Parkinson's disease, by restoring gamma-aminobutyric acid (GABA), which lessens STN activity.
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