Neurologix, Inc. (OTC Bulletin Board: NRGX) today announced that a landmark paper, published on October 20th in Science Translational Medicine demonstrating the importance of the p11 gene in modulating depression in mice, utilized a gene therapy approach to reverse depression in mice for which the Company holds exclusive development rights. Based on the findings reported in the paper, gene therapy may have potential as a new treatment option for people who suffer from severe depression.
In the study, reduced levels of the p11 protein in the nucleus accumbens (NAcc) of the brain were associated with depressive behaviors in mice. An AAV vector (adeno-associated virus, a disabled, non-pathogenic virus) was used to deliver the p11 gene back into the NAcc of mice who were lacking the p11 protein, reversing the depressive behavior and returning the animals to normal function.
The study also examined samples of brain tissue from a group of deceased human patients, half of whom had severe depression. It was found that there were significantly reduced levels of p11 in the NAcc of depressed patients compared to those without depression. This further highlights the importance of this research in providing a new avenue for future treatment of this widespread disorder.
Neurologix holds the exclusive license to a patent for p11 gene therapy in the treatment of psychiatric conditions, including depression, from Cornell University for and on behalf of the Joan & Sanford I. Weill Medical College. Neurologix scientific co-founder Michael G. Kaplitt, MD, PhD, is co-inventor on the patent, and is the senior author of the research paper.
"The publication of this important research validates our decision to secure the license for developing p11 gene therapy for eventual use in people with depression and other psychiatric disorders," said Clark A. Johnson, President and Chief Executive Officer of Neurologix. "Not only do we now know more about the role of the p11 gene in depression, but Neurologix has already demonstrated results using the same transfer technology, and an effective neurosurgical approach, in our Phase 1 and Phase 2 clinical trials for NLX-P101 in patients with Parkinson's disease. We see enormous potential in developing p11 gene therapy for therapeutic use."
Neurologix's investigational gene therapy, NLX-P101, uses the same AAV technology to deliver the GAD gene (glutamic acid decarboxylase) into the subthalamic nucleus region of the brain of Parkinson's patients. Earlier this year, Neurologix disclosed top-line results of a Phase 2 clinical trial of NLX-P101, announcing that study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.
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