Navigation Links
Neurologix presents 1-year data from phase 2 study of NLX-P101 in Parksinson's disease

FORT LEE, N.J., May 26, 2011 -- Neurologix, Inc. (OTCBB: NRGX) announced the presentation today of efficacy results through one year of follow-up in patients treated as part of the Company's successful Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD). Improvements in the Unified Parkinson's Disease Rating Scale (UPDRS) at 12 months for the randomized, double-blind, sham surgery-controlled trial of 45 subjects with advanced PD confirmed that patients treated with NLX-P101 experienced sustained, positive, long-term benefits. The one-year follow-up data were presented by one of the scientific co-founders of Neurologix, Michael G. Kaplitt, M.D., Ph.D., at the International Neuromodulation Society's (INS) 10th World Congress in London.

In the one-year follow-up analysis, patients treated with NLX-P101 who achieved previously defined moderate-to-large clinically-meaningful symptom improvements (≥ 9 points in off-medication UPDRS motor score), increased from 50 percent at six months to 63 percent at one year. This major subgroup of NLX-P101-treated patients experienced a mean 37 percent improvement in their symptoms after one-year, with an average improvement of 14 points in off-medication UPDRS motor score. Among all patients included in the NLX-P101 treatment group, the clinical improvements demonstrated at six months were maintained, with an average 8.2 point improvement in off-medication UPDRS motor score at 12 months compared to an 8.1 point improvement at six months. No serious adverse events (SAEs) related to the gene therapy or surgical procedure were reported in either the blinded six-month study period or the completed 12 month study phase.

"These results demonstrate that treatment with NLX-P101 improved the primary motor symptoms of Parkinson's disease in patients overall, with a majority obtaining a highly clinically meaningful improvement," said Neurologix scientific co-founder Matthew J. During, M.D., D.Sc., Professor of Molecular Virology, Immunology and Medical Genetics, Neuroscience and Neurological Surgery, The Ohio State University Medical School, and Professor of Molecular Medicine and Pathology, University of Auckland, New Zealand. "Further, the positive, durable responses we saw one-year after treatment with NLX-P101 in the Phase 2 study are consistent with the long-term efficacy demonstrated in our Phase 1 trial, the first ever to demonstrate the viability of gene therapy for the treatment of Parkinson's disease. The results from the first two phases of NLX-P101 clinical research give us great confidence in the potential of NLX-P101 as we move forward with our plans for the first Phase 3 trial for gene therapy in the treatment of this debilitating disease."

The six month results of the Company's landmark Phase 2 study were published in the peer-reviewed journal The Lancet Neurology in March of this year. Study results through six months of follow-up showed that NLX-P101 treatment led to a mean 23.1 percent improvement (8.1 points) in off-medication UPDRS motor score at the six-month study end-point, compared to a mean 12.7 percent (4.7 points) improvement with sham treatment. Improved motor control in the NLX-P101 group was seen at one month and continued virtually unchanged throughout the blinded six month study period. The improvement in UPDRS motor scores from baseline in the NLX-P101 group was significantly greater than sham subjects over the six month study period (p=0.04).

The Company's Phase 2 study findings build upon earlier positive results from the NLX-P101 Phase 1 trial, which appeared in 2007 as a cover article in The Lancet and in a second article in the Proceedings of the National Academy of Sciences. Neurologix plans to submit a Phase 3 protocol to the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment later in 2011.

"The results presented today at the INS World Congress add to a growing body of clinical evidence demonstrating that our novel gene therapy approach may provide significant clinical benefits to Parkinson's disease patients," During added. "In the treatment arm of the Phase 2 study, improved motor control was seen at one month, continued virtually unchanged throughout the six-month blinded study period and persisted through 12 months of follow-up. This suggests that the treatment effect from NLX-P101 is meaningful and durable over the long-term."

Drs. During and Kaplitt have been at the forefront of gene therapy research since 1989 and the Phase 2 trial was the culmination of nearly 20 years of progress with their work in gene transfer technology using an adeno-associated virus (AAV) vector (a disabled, non-pathogenic virus). They were the first to demonstrate that AAV could be an effective gene therapy agent in the brain, which they reported in their landmark Nature Genetics paper in 1994. Drs. During, Kaplitt and colleagues subsequently published additional research demonstrating the beneficial effects of AAV-GAD gene therapy for PD in the journal Science in 2002.


Contact: Marc Panoff
Edelman Public Relations

Related medicine news :

1. FAB-HOMES™ Presents First Passive House Collection
2. NOVAVAX Presents Positive Clinical Results at The World Health Organization Conference, Geneva, Switzerland
3. AADR presents honorary membership to Senator Tom Harkin
4. UCLA Health System Presents: How to Successfully Implement a Clinical Portal
5. Refine Dermatique Aesthetic Medical Team Presents Free Educational Event in Otsego, MN
6. CNBC Presents 'Tom Brokaw Reports: BOOMER$!' on Thursday, March 4th at 9PM ET/PT
7. Fifth Anniversary of Global Tobacco Control Treaty Presents Opportunity For U.S. Ratification and Leadership
8. CareTech Solutions Presents Specialized Healthcare Call Center at HIMSS10
9. Morehead Presents Webinar on "When Satisfaction Isn't Enough: Improving RN Engagement"
10. Targeting leukemia cells gene addiction presents new strategy for treatment
11. Keynote Speaker Presents Top Business Plan For Internal Communication Through Social Media
Post Your Comments:
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released ... failing their residents by lacking a comprehensive, proven plan to eliminate ... a definitive ranking of how states are tackling the worst drug ... only four states – Kentucky , ... Vermont . Of the 28 failing states, three – ...
Breaking Medicine Technology: