Representatives of Neuralstem have announced that the company received official “Notice of Allowance” from the U.S. Patent and Trade Office, for its technology that will immortalize stable neural stem cell lines.
The newly patented process utilizes cMyc-ER, which is a recombinant fusion of two proteins that are normally present in cells, namely, the estrogen receptor (ER) which is a human protein activated by estrogen, and c-Myc, which is a protein that regulates the human cell cycle.
According to Neuralstem president and CEO Richard Garr, “We are pleased to have received the Notice of Allowance on this important technology. The technology behind this patent allows us to grow practically unlimited quantities of neural stem cells from all regions of the brain without regard to the natural mitotic limits of cells from a particular region. Equally important, this technology is a next-generation immortalization process that avoids the harmful effects of traditional immortalization methods, which have invariably resulted in uncontrolled growth. Our technology provides the necessary assurance that the cell lines are fully controlled and remain consistent, trial over trial and year after year. This consistency is ultimately key to the commercialization of any cell products and greatly enhances our ability to deliver cell therapies for very prevalent diseases, such as stroke and traumatic brain injury. It will also enable, for the first time, systematic drug screening against many different kinds of normal human brain cells for new central nervous system drugs, and stem cell-mediated protein delivery for neurologic diseases.”
Neuralstem’s patented technology allows, for the first time, the production of neural stem cells from the human brain and spinal cord in commercial quantities, and for the controlled differentiation of these cells into human neurons and glial cells.
Researchers at Neuralstem are focused on major pathologies of the central nervous system including Huntington’s disease, ischemic spastic paraplegia, traumatic spinal cord injury, and amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease. In December of 2008, Neuralstem filed an IND (investigational new drug) application with the FDA for ALS and has also entered into a collaborative agreement with Albert Ludwigs University in Freiburg, Germany to develop clinical trials for Huntington’s disease.