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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

uch reduction in the sham group at any time point. Furthermore, 35% of sham subjects were reported to have worsening PD symptoms as an adverse event during the one year follow-up, consistent with the progressive nature of the disease, whereas such an adverse event was not recorded in a single NLX-P101 subject (p<0.005; Fisher's exact test).

"We were very pleased to be able to summarize our results to date for the RAC, which is an important step in our progress toward a definitive Phase 3 study," said Dr. During, Professor of Molecular Virology, Immunology and Medical Genetics, Neuroscience and Neurological Surgery, The Ohio State University Medical School, and Professor of Molecular Medicine and Pathology, University of Auckland, New Zealand. "These new results provide strong support for our earlier observation that NLX-P101 can substantially improve effectiveness of medications in patients who are no longer adequately responding to treatment while reducing complications of these same therapies. These findings support the results of our 2002 preclinical study reported in the journal Science in which we showed that GAD gene transfer is neuroprotective and provides encouragement that NLX-P101 may also have a disease-modifying effect. The strong results observed in both our Phase 1 and now Phase 2 studies increase our confidence in the potential of NLX-P101, and, combined with the outstanding safety profile to date, further justifies our plans to move toward the first Phase 3 trial for gene therapy in the treatment of this debilitating disease."

The six month results of the Company's landmark Phase 2 study were published in the peer-reviewed journal The Lancet Neurology in March of this year. Study results through six months of follow-up showed that NLX-P101 treatment led to a mean 23.1 percent improvement (8.1 points) in off-medication UPDRS motor score at the six-month study end-point, compared to a mean 12.7 percent improvement (4.7 p
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SOURCE Neurologix, Inc.
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