Neurologix, Inc. has announced that the U.S. 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 Parkinson’s disease.
Results of a Phase 1 clinical study showed that the Neurologix gene transfer procedure was both well tolerated and resulted in improved motor function and brain metabolism for patients with advanced Parkinson’s disease over the course of the one-year study. Neurologix is currently preparing to initiate a Phase 2 study of its Parkinson’s disease treatment by early 2008, subject to final FDA consent to the study protocol.
“The FDA’s Fast Track Designation for this gene transfer procedure for Parkinson’s disease recognizes the need for new therapies for patients with advanced Parkinson’s disease who no longer receive adequate benefit from their drug therapies alone,” said John Mordock, President and Chief Executive Officer of Neurologix.