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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

ed from the hospital within 48 hours after the surgical procedure.

The primary outcome measure was the difference in UPDRS motor scores between NLX-P101 and sham-treated subjects, when the subjects were off PD medication. Other tests assessed motor fluctuations, constancy of medication effect and neuropsychological evaluations. A clinically-meaningful response was defined based on a 25 percent mean improvement from the initial Phase 1 NLX-P101 study (9 points). Patients in the sham surgery arm of the study who continue to meet all eligibility requirements will be provided an opportunity to receive NLX-P101 in a planned cross-over study. Treated subjects continue to be evaluated in an open-label, long-term follow-up study.

A Novel Approach to Gene Therapy

NLX-P101 aims to reset the overactive brain cells in the STN to inhibit electrical activity and return brain network activity to more normal levels. In PD, the loss of dopamine-secreting neurons alters chemical signaling pathways in the brain such that input to the STN is altered. The therapeutic approach with NLX-P101 modulates the activity of the STN (which is overactive in PD) by restoring GABA, a neurotransmitter important in STN function. GABA is made by a gene called glutamic acid decarboxylase (GAD). NLX-P101 uses an AAV vector (a disabled, non-pathogenic virus) to deliver the GAD gene into the STN. Increasing GAD activity causes more GABA to be synthesized, thus helping to lessen the STN over-activity.

About Parkinson's disease

Parkinson's disease is a progressive and debilitating neurodegenerative disorder that arises from the gradual deterioration of nerve cells in the brain. It affects the control of bodily movement and is characterized by four principal features: limb tremor, limb rigidity, bradykinesia (slowness of movement) and postural instability (trouble with balance).  

Parkinson's disease is typically a disease that affects people over
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SOURCE Neurologix, Inc.
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