Neurologix, Inc., a biotech company committed to developing innovative gene therapies for the brain and central nervous systems, has entered into a licensing agreement with a subsidiary of Diamyd Medical, a biotechnology company based in Stockholm, Sweden, and Pittsburgh, PA.
Under the terms of the agreement, Neurologix has been granted a license for the use of the glutamic acid decarboxylase (GAD) 65 genes, a component of the core technology
"NLX-P101" gene therapy used in its recently completed, landmark phase I clinical trial. The company will pay Diamyd a license issue fee of $500,000 and will pay annual maintenance fees beginning in January 2008. Upon commercialization of the Parkinson's product, the company will also make certain milestone and royalty payments.
"The company may now go forward with the same product that demonstrated positive results in the phase I Parkinson's trial," stated John E. Mordock, CEO of Neurologix. "This agreement will facilitate the remaining clinical trials, and, upon completion of these trials, the company will file a new drug application (BLA) for Parkinson's disease with the FDA."
Mordock added, "Now, we are closer to our goal of creating a safe and effective, single-application treatment for Parkinson's disease, which affects millions of people around the world."
Neurologix's 12-patient, dose-escalating phase I trial was the world's first study to use a viral vector (the non-pathogenic adeno-associated virus, or AAV) for the treatment of an adult neurodegenerative disease. Trial patients experienced a marked improvement in motor function, as well as a statistically significant improvement in PET scans (a measure of brain metabolism).
Neurologix has an extensive intellectual property portfolio which, in combination with this agreement, now provides both freedom to operate and exclusive protection for its lead NLX-P101 Parkinson's disease gene therapy product. As CEO, Mr Mordock is leading the company's efforts to move from the research and development stage toward the regulatory and manufacturing stages and ultimately to commercialization.
The company's NLX gene therapy platform is designed to become an alternative therapy to current pharmaceutical and surgical treatments for a multitude of neurological disorders.