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Neurologix announces positive results of gene therapy clinical trial in Parkinson's disease

Investigators report safety findings and statistically significant improvements in clinical measures of movement, PET Scans at 19th Annual Symposia on the Etiology, Pathogenesis and Treatment of Parkinson's Disease and Other Movement DisordersNeurologix's Phase I trial showed positive interim results in patients with Parkinson's disease. One year following treatment, patients exhibited a statistically significant improvement in motor function on the side of their body correlating to the treated part of the brain. Further, PET scans at one year revealed that the treated side of the brain exhibited a statistically significant decrease in abnormal metabolism, results considered similar to those achieved with STN Deep Brain Stimulation.

FORT LEE, N.J., Sept. 26, 2005 -- Neurologix, Inc. (OTCBB:NRGX) today announced positive interim results of its landmark gene therapy clinical trial for patients with Parkinson's disease. Neurologix's 12-patient, dose-escalating Phase I trial is the world's first study to use a viral vector (the non-pathogenic adeno-associated virus, or AAV) for the treatment of an adult neurological disease. In the Neurologix-funded trial, the vector was injected into a specific target site in the brain in order to transfer a gene to treat Parkinson's disease. The gene encodes glutamic acid decarboxylase (GAD), an enzyme which synthesizes the major inhibitory neurotransmitter in the brain, (gamma)-aminobutyric acid (GABA).

Under the FDA-sanctioned trial protocol, patients with advanced Parkinson's disease received unilateral (one side of the brain) infusion of AAV-GAD via a hair-thin catheter into the subthalamic nucleus (STN), a deep brain structure known to function abnormally in Parkinson's patients. According to the interim findings, Neurologix's STN AAV-GAD treatment appears to be safe and well-tolerated in advanced Parkinson's disease, with no evidence of adverse effects or immunologic reaction related to the study treatment.
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Source:jjackson@burnsmc.com


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