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

esthesia, and avoids leaving any devices in the body. We look forward to the completion of the patient evaluations and the final analysis of these findings." Under the clinical protocols, the last cohort of patients was treated this past spring and will complete evaluations by mid-2006. Pending the final results, Neurologix intends to formulate and submit to the FDA a pivotal trial protocol for the use of STN AAV-GAD in the treatment of Parkinson's disease.

"The results of the trial are highly encouraging, in terms of both safety and efficacy," stated Eric J. Nestler, M.D., Ph.D., member of the Neurologix Scientific Advisory Board and Professor and Chairman, Lou and Ellen McGinley Distinguished Chair in Psychiatric Research, The University of Texas Southwestern Medical Center at Dallas. "These are very exciting findings. If the efficacy demonstrated here is replicated in a definitive trial, it would represent a fundamentally new platform for the treatment, not only of Parkinson's disease, but of a large number of neurological and psychiatric disorders as well. Such a replication would make viral-mediated gene therapy for brain diseases a reality."

Dr. Paul Greengard, Nobel Laureate, Vincent Astor Professor and Head of the Laboratory of Molecular and Cellular Neuroscience at Rockefeller University, and Chairman of the Neurologix Scientific Advisory Board, commented, "The initial results of the trial are very encouraging. To achieve, in a phase I study, statistically significant improvement in both motor scores and PET scans at one year is impressive, particularly given the absence of these changes on the untreated side of the brain. We look forward, now, to a pivotal trial to even more vigorously test and corroborate these important results."

About the Neurologix Phase I Clinical Trial

The Phase I trial, which is the first FDA-approved clinical trial to test gene therapy to treat Parkinson's disease, is an open-label dos
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Source:jjackson@burnsmc.com


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