[Howardh]

Neurologix http://www.neurologix.net moves forwards with a recruitment call for their phase two stage.

It seems a life time ago when in 2003 Dr Mat During and other super stars successfully applied their Gene Therapy Formulae to 10 athletes eeerrr patients headed by Nathan Klien. The initial trial made headlines around the world. I still have the front page photo and report of Nathan and Proffessor During which apppeared in our National (NZ Herald) newspaper at that time.

read more...good stuff

http://phx.corporate-ir.net/phoenix....500&highlight=

[aftermathman]

we really need some good news on this one, probably the oldest and most researched of the gene therapy products.

Good luck guys,
Neil.

http://phx.corporate-ir.net/phoenix....678&highlight=

Neurologix Commences its Phase 2 Clinical Trial of Novel Gene Transfer Approach for Treatment of Parkinson's Disease

FORT LEE, N.J.--(BUSINESS WIRE)--Jan. 21, 2009--Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today that it has initiated its Phase 2 clinical trial for the treatment of advanced Parkinson's disease. The first trial participants have undergone surgery at multiple institutions and additional subjects are currently being enrolled.

The purpose of the trial is to validate the safety and efficacy of Neurologix's gene transfer therapy, a novel non-dopaminergic approach to restore motor function in Parkinson's patients who are sub-optimally responsive to available drug therapy. Neurologix's approach is to reestablish the production of GABA (gamma-aminobutyric acid), the major brain inhibitory neurotransmitter that helps "quiet" excessive neuronal firing and has been determined to be deficient in patients in the advanced stages of Parkinson's disease.

John E. Mordock, President and Chief Executive Officer of Neurologix, stated, "Initiating this Phase 2 clinical trial represents a significant milestone. We expect to enroll 40 subjects across six to eight leading U.S. academic research centers, with completion of enrollment expected during the second half of 2009."

In Parkinson's disease there is degeneration of many cells in the central nervous system including those that produce dopamine, which leads to a downstream deficiency in GABA signaling in areas of the brain that regulate movement. Most current therapies and research approaches target dopamine. Mr. Mordock commented, "In contrast, our preclinical and clinical research suggests that directly targeting GABA production rather than dopamine replacement may be a more effective way of improving brain function in late-stage Parkinson's disease while also avoiding the known therapeutic limitations and complications associated with the over-production of dopamine."

The Co-Chairmen of the trial Steering Committee are Dr. Andrew Feigin, Director of the Neuroscience Experimental Therapeutics Research Program at the Feinstein Institute of Medical Research of the North Shore-Long Island Jewish Health System, and Dr. Peter LeWitt, a neurologist who directs the Parkinson's Disease and Movement Disorders Program at Henry Ford Hospital in Southfield, Michigan.

"Based on the encouraging functional and imaging results seen in the Phase 1 study of this innovative approach to improving Parkinson's disease, we are extremely excited to be part of this study," said Dr. Feigin.

Dr. LeWitt added, "The start of this clinical trial provides hope to the patient population which has had a longstanding need for new treatment options."

The scientific underpinnings of Neurologix's approach have undergone rigorous peer review resulting in highly cited articles in Nature Genetics and Science by the company's co-founders, Drs. Matthew During and Michael Kaplitt. Moreover, the current trial follows a successful Phase 1 study, as published in the Lancet and Proceedings of the National Academy of Sciences, USA, in which 12 subjects completed the study showing no related serious adverse events and significant functional benefit with supportive imaging data.

Phase 2 Clinical Trial Design

As previously announced, 20 participants will receive an infusion of the gene-based treatment bilaterally via a catheter temporarily placed by stereotactic surgery in each participant's subthalamic nucleus (STN), a deep brain structure that is the main target of surgery to treat Parkinson's disease. The other 20 participants will receive sterile saline solution into a partial thickness burr hole made into the skull, with no brain infusion. Trial participants will be assessed for treatment effects by standardized Parkinson's disease ratings at multiple time points post-procedure. The primary endpoint for the trial will be a clinical assessment of motor function at 6 months using the Unified Parkinson's Disease Rating Scale (UPDRS). All participants in the trial will also be monitored for safety for 12 months following the gene transfer procedure. If the primary endpoint is met following the analysis of 6 month data, then the sham-control participants will be offered the opportunity to crossover into an open label study of the Neurologix gene transfer therapy if they continue to meet all entry, medical and surgical criteria.

For details about participating in the clinical trial, please visit the following link: http://clinicaltrials.gov/ct2/show/N...rologix&rank=1. Details about trial participation are also available at http://www.pdtrials.org/en/browse/all/view/241.

About the Neurologix Gene Transfer Approach to Parkinson's Disease

In Parkinson's disease, patients lose dopamine-producing brain cells, resulting in substantial reductions in the activity and amount of GABA (gamma-aminobutyric acid). This reduction in GABA causes a dysfunction in brain circuitry responsible for coordinating movement. GABA is made by a gene called glutamic acid decarboxylase, or GAD.

Neurologix's gene transfer approach to Parkinson's disease seeks to restore GABA -- and thus improve the patient's motor control -- by inserting the GAD gene back into an area of the brain called the subthalamic nucleus, a key regulatory center for movement.

[paula_w]

Thanks, I'm considering this trial. I'm somewhat disillusioned with cere 120 and its' communications and transparency. Waiting for a call from Wake Forest. Think I'll check it out at least.


paula