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Successful one year gene therapy trial for Parkinson's disease announced by
Neurologix
Trial demonstrated safety and statistically significant improvement in both
motor function and brain metabolism at one year
Fort Lee, NJ, (October 17, 2006) ¯ Neurologix, Inc. (OTCBB: NRGX), a biotech
company engaged in the development of innovative gene therapies for
disorders affecting the brain and central nervous system, announced today
that it has successfully completed its landmark Phase I trial of gene
therapy for Parkinson's Disease with statistically significant results. The
data was presented at the 36th Annual Meeting of the Society of Neuroscience
in Atlanta.
In a presentation entitled "Subthalamic GAD gene transfer improves brain
metabolism associated with clinical recovery in Parkinson's Disease,"
Matthew J. During, MD, D.Sc. presented findings of the open label, dose
escalating, unilateral trial, which confirmed the safety and tolerability in
all 12 patients studied out to one year. Though efficacy was only designated
as a secondary outcome, the trial also yielded statistically significant
clinical efficacy and neuro-imaging results.
At one year, all 12 patients as a group demonstrated a clinical improvement
of 25% in the Unified Parkinson's Disease Rating Scale (UPDRS) compared to
baseline (p < 0.005). Nine of the 12 patients showed an average improvement
of 37%, and 5 of these patients had substantial improvement of between 40%
and 65%. "This gene therapy trial is particularly unique and the clinical
data unusually promising because the treatment was confined to just one side
of the brain," stated Dr. During. In its next trial, the Company plans to
infuse its treatment into both sides of the brain.
Clinical improvement also correlated well to metabolic brain changes as
measured by Positron Emission Tomography (PET) scan. PET is an imaging
method that measures brain metabolism following the injection of a
radioactive analog of glucose (fluorodeoxyglucose). The PET scan data
revealed a significant improvement (p < 0.001) in brain metabolism on the
treated side of the brain as compared to the untreated side.

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