US fast-track for Neurologix' gene therapy approach

Neurologix, a US biotechnology company engaged in the R&D of innovative gene therapies for the brain and central nervous system, says that the Food and Drug Administration has granted Fast Track Designation for the company's experimental gene transfer procedure for the treatment of advanced Parkinson's disease.

The Neurologix procedure delivers a gene (glutamic acid decarboxylase, or GAD) to the subthalamic nucleus of the brain, where it makes an inhibitory neurotransmitter called GABA that helps to quiet the abnormal brain activity that is correlated with motor deficits characterizing PD. Results of a Phase I clinical study showed that the procedure was both well tolerated and resulted in improved motor function and brain metabolism for patients with advanced disease over the course of the one-year study. The company is currently preparing to initiate a Phase II trial of its PD treatment by early 2008, subject to final FDA consent to the study protocol.