Neuralstem, Inc. has received a notice of allowance for patent application 12/404,841. This patent covers methods for treating amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) with expanded spinal cord stem cells, including NSI-566. Neuralstem completed a phase I safety trial of its NSI-566 stem cells in ALS earlier this year, for which it has also been granted an Orphan Drug Designation.
The company plans to initiate phase II of the trial, pending approval from the US Food and Drug Administration (FDA).
"Our past patent claims cover methods of culturing and treating neurodegenerative conditions with our NSI-566 cells," said Karl Johe, PhD, Neuralstem chairman & chief scientific officer. "The claims being allowed here cover methods for using these cells specifically in the treatment of ALS, an indication in which we have already reported peer-reviewed patient data and anticipate advancing to a phase II study soon."
"Neuralstem is constantly working to strengthen the intellectual property portfolio around our core technology," said Richard Garr, Neuralstem CEO and president. "At the same time, we continue to expand a cell therapy clinical program that is already robust."
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia.