April 5, 2013
/PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced today that it received a notice of allowance for patent application 12/404,841. This patent covers methods for treating amyotrophic lateral sclerosis (ALS or
'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 Food and Drug Administration.
"Our past patent claims cover methods of culturing and treating neurodegenerative conditions with our NSI-566 cells," said
, 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
, 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. Neuralstem completed an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as
's disease, in
, and is awaiting FDA approval to begin Phase II. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company received approval to commence a Phase I safety trial in chronic spinal cord injury in
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).