Neuralstem, Inc. (NYSE Amex: CUR) announced it has signed a Memorandum of Understanding with BaYi Brain Hospital in Beijing, China. Under the agreement, BaYi Brain and Neuralstem will jointly prepare a clinical protocol for treatment of motor deficits due to ischemic stroke.
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BaYi Brain will prepare the Mandarin version of the clinical trial documents and submit the documents to the Hospital's Ethics Board for review and approval. Upon approval of the trial protocol by the Hospital's Ethics Board, BaYi Brain then submit the documents to the Military Regulatory Agency for review and approval of the trial. BaYi Brain will be the site of the trial, which Neuralstem will sponsor.
"The Chinese government has recently announced its desire to become a prominent player in the field of stem cell transplantation and regenerative medicine," said Karl Johe Ph.D., Chairman and Neuralstem Chief Scientific Officer, who was in Beijing to sign the agreement. "We are honored and excited to begin this process at BaYi Brain Hospital, one of the premier neurological hospitals in China."
"The incidence of ischemic stroke in China is estimated to be at least 2.5 million people per year, with a roughly 70% survival rate. China has by far the world's largest chronic stroke population. This enormous demonstrated need is one reason that we founded our wholly-owned subsidiary, Neuralstem China, in 2010," said Richard Garr, Neuralstem's President & CEO.
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 is in a FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is also targeting major central nervous system diseases, including traumatic spinal cord injury, ischemic spastic paraplegia, and Huntington's disease. The company has also submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.
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 has commenced a FDA-approved Phase Ia safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder. Additional indications could include schizophrenia, Alzheimer's disease, traumatic brain injury, posttraumatic stress syndrome, and stroke.