GERMANTOWN, Md., Nov. 10, 2014 /PRNewswire/ -- Neuralstem, Inc.
(NYSE MKT: CUR) announced the publication of results evaluating
long term cell survival and differentiation of NSI-566 transplanted
human spinal-cord derived neural stem cells (HSSC) in Annals
of Clinical and Translational Neurology (access now available). The
study concluded that Neuralstem's investigational Phase I NSI-566
HSSCs survived for up to 2.5 years post-transplant in six of the
amyotrophic lateral sclerosis (ALS) Phase I patients. This
was the first-ever clinical study approved to transplant HSSCs in
the spinal cord.
In the article, "Analysis of graft survival in a trial of stem
cell transplant in ALS," researchers found no correlation of
DNA content to survival period after immunosuppressant medications
had been discontinued. These data demonstrate that
transplanted HSSCs can survive for a prolonged period, even in the
absence of immunosuppression. This suggests that continued
immunosuppression is not necessary for the continued survival of
the transplanted cells. All six patients accessed in
this publication received NSI-566 cells as part of a clinical
study, but subsequently died from their disease or other
causes. Using advanced imaging technology, NSI-566 DNA was
identified in all cases. The percentage of donor DNA ranged
from 0.67% to 5.04% of total DNA. Neuralstem's
previously-published Phase I results determined NSI-566 cell
therapy was safe and well-tolerated.
"The success of our therapy is predicated upon our cells ability
to survive long-term and differentiate, providing neurotrophic
support in the spinal cord and acting as 'nurse' cells for the
patients' own motor neurons that are attacked by the
disease," said Karl Johe, PhD,
Neuralstem Chairman and Chief Scientific Officer. " This new study
presents an elegant demonstration that the NSI-566 cells survived
long term and differentiated as expected, enabling their promise as
a neuroprotective, and neurorestorative, treatment for ALS and
other neurodegenerative conditions."
About Neuralstem
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 (PTSD).
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 September 30, 2014.
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SOURCE Neuralstem, Inc.