Concerns about PhII Parkinson gene therapy sends Neurologix into bankruptcy
This article was originally published in Scrip
Neurologix Inc. filed for voluntary Chapter 7 bankruptcy protection in US Bankruptcy Court for the District of Delaware on 16 March to liquidate assets after it spent the past year looking for financing or a partner to advance its Parkinson's disease gene therapy into Phase III clinical trials.
The Fort Lee, New Jersey-based gene therapy developer focused on neurological diseases said in court documents that it has $1.2 million in assets and $12.9 million in debt. It listed 82 different creditors, 28.2 million shares of preferred stock and 28 million shares of common stock outstanding. A meeting of Neurologix creditors is scheduled for 17 April in Delaware.
On 14 February, Neurologix engaged Global Resource Partners Inc. for $10,000 per month on a month-to-month basis to act as the company’s chief financial officer and explore its financing options four days after CFO Marc L. Panoff resigned.
It was the most recent of several personnel changes at Neurologix. Various board members and executives have changed roles or resigned since 2010.
After just two months with the company, Neurologix CEO and chairman Adrian Adams, and president, chief administrative officer and director Andrew I. Koven resigned on 29 November, and board member Clark A. Johnson took over as CEO and chairman on 30 November, earning no salary for his service to the company. Mr. Johnson has been a board member since 2004, and was president, CEO and vice chairman of Neurologix from March 2010 to September 2011.
Company co-founder John Mordock resigned from his president and CEO positions in March 2010. Co-founder Dr Martin Kaplitt remains on the Neurologix board, but he ceded the chairman role to Adams in September 2011.
The high point for Neurologix came with the publication of Phase II clinical trial results for NLX-P101, its glutamic acid decarboxylase gene therapy for Parkinson’s disease, in the journal Lancet Neurology in March 2011 (scripintelligence.com, 17 March 2011).
Neurologix's gene therapy consists of introducing an adeno-associated virus into the subthalamic nucleus of the brain to deliver the company’s glutamic acid decarboxylase gene along with a proprietary promoter with the goal of increasing production of γ-aminobutyric acid (GABA) to selectively mimic normal physiology and alter the neural circuitry.
The Phase II study demonstrated reduced subthalamic nucleus over-activity, but did not show how long the effects of treatment would last or establish the long-term effects of the virus used to deliver the gene therapy.
Mr Panoff said when the Lancet study was published that the company needed a partner, new financing or a combination of the two to conduct Phase III studies, or else it would run out of cash by the end of 2011, which now seems to be the case.
In 2010, Neurologix was one of a handful of companies investigating gene therapy for Parkinson's Disease, including Oxford Biomedica with ProSavin and Ceregene with CERE-120, but NLX-P101 was the only non-dopamine gene therapy in development at that time (scripintelligence.com, 16 April 2010)
In December, ProSavin presented interim data from its Phase I/II studies and Ceregene completed enrollment for its Phase II clinical trial for CERE-120.