BioCentury
ARTICLE | Clinical News

AAV-GAD: Additional Phase II data

June 27, 2011 7:00 AM UTC

Additional data from a double-blind, U.S. Phase II trial in 45 patients showed that 63% of patients who received NLX-P101 infused bilaterally into the subthalamic nucleus achieved a >=9 point improvement in off-medication motor scores on the UPDRS Part III at 12 months, up from 50% of patients at 6 months. Additionally, the 8.1 point improvement in mean off-medication motor scores that was observed at 6 months in patients treated with NLX-P101 was maintained at 12 months (8.2 points). NLX-P101 also significantly increased mean daily "on" time in which patients were symptom free by 2.5 hours from baseline to 3 months, and was sustained at 12 months (2.1 hours; p<0.01 for both). There was no significant increase in daily "on" time for patients who received a sham infusion of saline at any time point. ...