Neuralstem Announces Publication of Results from Phase 1 Clinical Trial Evaluating Human Neural Stem Cells in Chronic Stroke Patients
GERMANTOWN, Md., July 1, 2019 /PRNewswire/ -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, announced the publication of a manuscript in Stem Cells Translational Medicine describing the results of an open label Phase 1 clinical trial evaluating the feasibility and safety of transplantation of its lead stem cell asset, NSI-566, for the treatment of motor deficits due to ischemic stroke. The publication can be found here.
The manuscript, entitled 'Stable Intracerebral Transplantation of Neural Stem Cells for the Treatment of Paralysis Due to Ischemic Stroke,' summarizes the results of an open label trial performed at BaYi Brain Hospital in Beijing, China, with Principal Investigator Professor Xu Ruxiang. Each of the nine subjects in the study had sustained chronic motor deficits due to an ischemic stroke 5-24 months prior to enrollment, and were divided into three cohorts receiving intracerebral injections of NSI-566 cells totaling 12, 24, or 72 million cells. Subjects were maintained on immunosuppressive drugs for 28 days following transplantation and were monitored for up to 24 months after surgery. The treatment was well tolerated at all doses and subjects showed stable increases in Fugl-Meyer Motor Scores from baseline, indicating the procedure is safe and may have potential to provide benefit to patients with motor deficits from stroke.
'We are grateful to our collaborators at BaYi Brain Hospital and to the subjects who participated in the trial,' said Dr. Ken Carter, Executive Chairman of Neuralstem. 'Although this is a small feasibility study, we are encouraged by the safety profile of this procedure, which has led us to initiate a placebo-controlled trial at this same site in September of 2018.'
About Ischemic Stroke
Ischemic stroke, the most common type of stroke, occurs as a result of an obstruction within a blood vessel supplying blood to the brain. Approximately 15 million people worldwide suffer stroke, of which approximately 87% are ischemic strokes. Post-stroke motor deficits include paralysis in arms and legs and can be permanent.
Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. The Company has two lead development candidates:
- NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI)
- NSI-189, is a small molecule in clinical development for major depressive disorder and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, diabetic neuropathy, and stroke
Neuralstem's diversified portfolio of product candidates is based on its proprietary neural stem cell technology.
Cautionary Statement Regarding Forward Looking Information
This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.
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SOURCE Neuralstem, Inc.
Released July 1, 2019