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NEURALSTEM ALZHEIMER'S DISEASE
ANIMAL DATA PRESENTED AT THE CONGRESS OF NEUROLOGICAL SURGEONS ANNUAL MEETING
GERMANTOWN, MD, October 23, 2014 --
Neuralstem, Inc. (NYSE MKT: CUR) announced that the first data in a study transplanting its neural stem cells in an animal model
of Alzheimer's disease was presented at the Congress of Neurological Surgeons Annual Meeting, yesterday, in Boston, MA. In
a late-breaking science oral presentation titled, "Peri-hippocampal stem cell transplantation rescues cognitive decline in
Alzheimer's disease," Osama N. Kashlan, MD, of the departments of Neurology and Neurosurgery at the University of Michigan
Medical School, concluded that HK532: IGF1 (NSI-532.IGF) cells rescued spatial learning and memory deficits in mice with an animal
model of Alzheimer's disease. NSI-532.IGF cells, Neuralstem's second stem cell product, are a cortical neural stem
cell line that has been engineered to produce human insulin-like growth factor 1 (IGF-1), which has been shown to have wide-ranging
neuroprotective properties. Furthermore, the researchers also reported that the cells, which were injected in the peri-hippocampal
region, survived for up to ten weeks. The hippocampus plays an important role in memory encoding and retrieval. It is also one
of the first regions of the brain to be affected in Alzheimer's disease. The researchers concluded that this approach could
provide a viable approach to treat Alzheimer's disease in the future.
"Fourteen weeks after the surgery,
the stem cell-injected mice performed significantly better than the control mice," said Dr. Kashlan. "They were smarter.
We were not prepared for the magnitude of the effect, it was rather stunning. It gives us hope to be part of treating this horrendous
disease. Everyone knows someone who is affected by Alzheimer's disease. These results are obviously preliminary, but very
"The NSI-532.IGF stem cells used
in this study are a cortical stem cell line engineered to deliver an extra therapeutic power, in this case IGF-1, in addition to
the stem cells themselves," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "All of
our ongoing human trials involve our spinal cord stem cells. This pipeline expansion into a different neural stem cell line highlights
the platform nature of our technology that enables us to isolate and commercially develop stem cells from different regions of
the central nervous system to treat different indications.
"This is also the first instance
in which we are demonstrating the ability of the cells to act as a stable delivery vehicle for gene therapy in the central nervous
system (CNS)," Dr. Johe continued. "Getting large molecules across the blood brain barrier into the CNS has proven
extremely difficult. Our cells, which integrate seamlessly in the CNS under the blood brain barrier, present a unique delivery
vehicle to overcome this limitation. This study presents an elegant demonstration of the efficacy of this process. Although we
focus on the hippocampus, the cells and the therapeutic protein distribute widely and provide global therapeutic effects throughout
Neuralstem's patented technology enables
the production of multiple types of brain and spinal cord neural stem cells in commercial quantities for the potential treatment
of central nervous system diseases and conditions. Neuralstem's first stem cell product, NSI-566, a spinal cord-derived neural
stem cell line, is in an ongoing clinical trial to treat amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). Phase
II surgeries were completed in July, 2014. A later stage trial is anticipated to commence in 2015 at multiple centers. Neuralstem
received orphan status designation by the FDA for NSI-566 in ALS. In addition to ALS, NSI-566 is also in a Phase I trial in chronic
spinal cord injury at UC San Diego School of Medicine. NSI-566 is also in clinical development to treat neurological diseases such
as ischemic stroke and acute spinal cord injury.
Neuralstem's second stem cell
product, NSI-532.IGF, consists of human cortex-derived neural stem cells that have been engineered to secrete human insulin-like
growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued
spatial learning and memory deficits in an animal model of Alzheimer's disease.
Additionally, Neuralstem's ability
to generate human neural stem cell lines for chemical screening has led to the discovery and patenting of compounds that may stimulate
the brain's capacity to generate neurons, possibly reversing pathologies associated with certain central nervous system (CNS) conditions. The
company has completed Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the
treatment of major depressive disorder (MDD), and is expecting to launch a Phase II study for major depressive disorder (MDD) in
2015. Additional indications might include traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder
For more information, please visit
www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn
Cautionary Statement Regarding Forward
Looking Information:
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding
potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties,
including, without limitation, 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, 2013 and Form
10Q, for the period ended June 30, 2014.