Neuralstem, a biopharmaceutical company, continues its work on a cure for ALS, amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. Beginning in January, 2010, Neuralstem has been transplanting its NSI-566 spinal cord neural stem cells into patients that can and cannot walk, Phase I of its NSI-566 testing. The Phase I testing was designed to inject the sample cells into 18 patients and has taken place at the Emory ALS Center in Atlanta. The principal investigator in the trial is Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System.
Yesterday, Neuralstem reached another milestone in its Phase I testing. Neuralstem announced it had injected the NSI-566 cells into the 18th patient. The eighteenth patient is the third to return to the trial for an additional set of injections. This patient is also the final patient in the Phase I portion of the trial as it is currently designed. The Phase I portion of the trial is scheduled to conclude six months after this final surgery.
Asked to comment, Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer said, "We are delighted to have completed Phase I in this groundbreaking trial, the first approved by the FDA to test neural stem cells in patients with ALS."
"There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both," stated Jonathan D. Glass, MD, Director of the Emory ALS Center. "This has required incredible effort from the Emory medical and support team and I wish to express my thanks to all of them, as well as to acknowledge the generosity and courage of the patients and their families."
Dr. Feldman, an unpaid consultant to Neuralstem, added,"[w]e have found the procedure to be extremely safe." She continued, "In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful."
After testing via lower spine injections, the trial advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The last cohort of three received injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The entire 18-patient trial is set to conclude six months after the final surgery.
Neuralstem's patented technology gives it the power to produce neural stem cells of the human brain and spinal cord in commercial quantities. Neuralstem has the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia, which are supportive cells in the central nervous system.
The company is also focusing on major central nervous system conditions with its cell therapy platform. Neuralstem is looking to cure spinal cord injury, ischemic spastic paraplegia, and chronic stroke. In fact, the company has 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. If the brain has the capacity to generate new neurons, this could potentially reverse 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). NSI-189 might also be effective in treating chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
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