Neuralstem Announces Last Subject Enrolled in Phase 2 Clinical Trial Evaluating Human Neural Stem Cells in Chronic Stroke Patients
GERMANTOWN, Md., Sept. 24, 2019 /PRNewswire/ -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, announced completion of subject enrollment in its Phase 2 clinical trial of NSI-566 for the treatment of chronic ischemic stroke. NSI-566 is Neuralstem's lead stem cell therapy candidate, and has also been evaluated in clinical trials for patients with Amyotrophic Lateral Sclerosis and chronic spinal cord injury. The trial is being conducted at the BaYi Brain Hospital (affiliated to the 7th Medical Center of the PLA General Hospital) in Beijing, China under the direction of Professor Xu Ruxiang.
"Completing the subject enrollment in this Phase 2 study is an important clinical milestone for Neuralstem," said Dr. Ken Carter, Executive Chairman of Neuralstem. "We expect results from this study in the second half of 2020 and are thankful to the individuals and physicians who are participating."
The double-blind, placebo-controlled study enrolled 22 subjects that were randomized to one of two groups: a treatment group that received intracerebral administration of 72 million human neural stem cells or a sham surgery group. Subjects enrolled in the study were to have sustained chronic motor deficits due to an ischemic stroke 4-24 months prior to enrollment, and will be evaluated for measures of efficacy for 12 months after surgery and measures of safety for an additional 48 months.
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, 2018 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.