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news.Neurologix has announced that the FDA has allowed the company to proceed with its planned Phase II clinical trial in subjects with advanced Parkinson's disease.
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The goal of the Phase II clinical trial is to further determine safety of the Neurologix gene transfer therapy and to confirm the initial efficacy reported in the company’s Phase I clinical trial. The randomized, blinded study will take place at up to ten centers across US, and will enroll approximately 44 subjects with advanced Parkinson’s disease.
The company has developed a novel gene transfer approach to treating patients with Parkinson’s disease who no longer receive adequate benefit from current drug therapies.
John Mordock, president and CEO of Neurologix,said: “We have been contracting with clinical sites and reviewing prospective trial subjects for this study, which should begin patient enrollment during the second quarter.”