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neuralstem inc (CUR) Details

Neuralstem, Inc., a biopharmaceutical company, focuses on the development and commercialization of treatments for central nervous system disease based on human neural stem cells and the use of small molecule compounds. The company’s stem cell technology enables the isolation and expansion of human neural stem cells from various areas of the developing human brain and spinal cord enabling the generation of physiologically relevant human neurons of various types. Its clinical program products include NSI–566, which is in Phase II clinical trials for the treatment of amyotrophic lateral sclerosis, and Phase I clinical trials for chronic spinal cord injury. The company’s clinical development products also comprise NSI–566 that is in Phase I/II clinical trials for motor deficits due to ischemic stroke in China; and NSI–189 that is in Phase Ib for the treatment of major depressive disorders. Neuralstem, Inc. was founded in 1996 and is headquartered in Rockville, Maryland.

15 Employees
Last Reported Date: 03/10/14
Founded in 1996

neuralstem inc (CUR) Top Compensated Officers

Co-Founder, Chief Executive Officer, Presiden...
Total Annual Compensation: $602.4K
Co-Founder, Chairman and Chief Scientific Off...
Total Annual Compensation: $675.4K
Senior Vice President of Research
Total Annual Compensation: $281.3K
Compensation as of Fiscal Year 2012.

neuralstem inc (CUR) Key Developments

Institutional Review Board of the University of California Approves Phase I Safety Trial of Neuralstem, Inc. to Treat Chronic Spinal Cord Injury with its NSI-566 Stem Cells

Neuralstem, Inc. announced that the Institutional Review Board of the University of California, San Diego, School of Medicine has approved the Phase I safety trial to treat chronic spinal cord injury (cSCI) with its NSI-566 stem cells. The NSI-566/cSCI Phase I trial will enroll patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment, which is complete paralysis, refers to a patient with no motor or sensory function in the relevant segments at and below the injury. The trial, which already has FDA approval, and has a one-year completion goal, will be under the direction of principal investigator (PI) Joseph Ciacci, MD, UC San Diego School of Medicine and neurosurgeon at UC San Diego Health System. Much of the pre-clinical work with the NSI-566 cells in spinal cord injury was conducted at UC San Diego School of Medicine by Martin Marsala, MD, professor in the Department of Anesthesiology, who will be another study investigator.

Neuralstem, Inc. Announces First Study to Validate Cell Survival and Functionality in Brain, Improvement Dose Dependent

Neuralstem, Inc. announced that a study, PLOS ONE, showed that ischemic-stroke rats transplanted with Neuralstem's NSI-566 stem cells in the brain experienced functional improvements. Furthermore, the grafts both survived and differentiated into neurons. These findings further validate the application of the cells for transplantation therapy in ischemic stroke. The researchers concluded that the NSI-566 cells are potent cell donors for transplantation therapy to treat paralysis in stroke patients. Neuralstem is currently conducting a Phase II NSI-566 clinical trial in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) in three U.S. sites, as well as a Phase I/II to treat post-stroke motor deficit in China, through its wholly-owned subsidiary, Neuralstem China. The company also has been approved by the FDA to commence a trial with the same cells to treat chronic spinal cord injury. In a study of 40 rats, all received strokes in the brain via cerebral artery occlusion, a well-established stroke model. Seven-days post stroke, the animals were divided into four groups. Group A received no stem cells. Groups B and C received 5,000 and 10,000 NSI-566 cells/ul, respectively and group D received 20,000 cells/ul. All groups had displayed typical stroke-induced behavioral deficits after stroke and prior to transplantation. Seven days after transplantation, the animals were tested again at intervals that continued throughout the duration of the study, 56 days post-transplantation.

Neuralstem, Inc. Announces Final Results from the Phase I Safety Trial

Neuralstem, Inc. announced that the final results from the Phase I safety trial using NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) were published. In Intraspinal Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis: Phase I Trial Outcomes,' results were updated from Phase I interim data, reported earlier, to include data from the last six patients in the trial. These six patients were the first to receive cervical stem cell transplants. Three of them were also the first to be transplanted along the length of their spines, in both the lumbar and the cervical regions. The results showed that NSI-566 human spinal cord stem cells can be safely transplanted in both the lumbar and cervical spinal cord segments, did not accelerate disease progression, and warrant further study on dosing and therapeutic efficacy. Furthermore, the researchers were able to identify potential therapeutic windows, suggesting that more injections, as well as multiple injections, are better and may increase both the length and the magnitude of the potential benefits. This is consistent with the hypothesized neuroprotective mechanism-of-action for this cell therapy. Since concluding Phase I, the trial has progressed to Phase II at three centers, Emory University Hospital in Atlanta, Georgia, the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston, Massachusetts, which treated its first patient in February. Treatment of three of the five Phase II cohorts has been completed.


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