GERMANTOWN, Md., Jan. 27, 2016 /PRNewswire/ -- Neuralstem,
Inc. (Nasdaq: CUR), a biopharmaceutical company using neural stem
cell technology to develop regenerative therapies and small
molecule pharmaceutical drugs for CNS diseases and disorders,
announced that Karl Johe, Ph.D.,
Neuralstem's Chairman and Chief Scientific Officer, provided an
update on the company's ongoing NSI-566 cell therapy clinical
programs at the Phacilitate Cell & Gene Therapy World
conference in Washington D.C.
The presentation reviewed the company's NSI-566 human spinal
cord-derived neural stem cells investigational trials for the
treatment of amyotrophic lateral sclerosis (ALS), chronic spinal
cord injury (cSCI), and motor deficits due to ischemic stroke. Dr.
Johe highlighted the consistent biological activity and multiple
modes of therapeutic actions, including the rescue of motor
neurons, motor improvement, and neuronal integration in NSI-566
animal and human clinical data. He concluded that the collective
trial data analysis showed the cells consistently demonstrated
biological activity in all three indications.
Neuralstem's NSI-566 cells have been safely administered to 40
patients, in dosing ranges of 1.2 million to 24 million cells per
patient, in four investigational safety trials. The consistent
safety profile continues to validate Neuralstem's physiologically
relevant stem cell technology platform. The company and its
collaborators from leading research institutions conclude that the
data supports the advancement of clinical development in each of
the three indications.
"The consistent biological activity of motor improvement by
NSI-566 across multiple disease conditions in humans supports our
regenerative hypothesis and is consistent with our preclinical
data," said Dr. Johe. "Based on these encouraging results, we are
preparing to conduct additional clinical trials in in each of these
incurable neurodegenerative indications."
NSI-566/ALS: A review of the Phase I and Phase II trials
suggested a treatment-emergent improvement of function along
multiple endpoints, including improved lung capacity, muscle
strength, and a slowing of ALS progression. Phase I data shows
long-term graft survival with transient immunosuppression.
Additionally in Phase II, the data revealed that more than 50% of
the patients experienced a reduction in the ALS Functional Rating
Scale (ALSFRS) decline when compared to historical data sets. The
remaining subjects, the majority of which had very low grip
strength at entry, did not experience a change in their rate of
decline. Based on these observations, the next trial will only
include patients with sufficient muscle strength remaining for
potential rescue.
NSI-566/cSCI: The Phase I feasibility study involved four
AIS A thoracic-spinal cord injury patients (motor and sensory
complete), one-to-two years post-injury at the time of stem cell
treatment. They each received 1.2 million cells in six injections
around the site of the spinal cord injury. The stem cell treatment
demonstrated feasibility and safety; there were no serious adverse
events. A self-reported ability to contract some muscles below the
level of injury was confirmed via clinical and electrophysiological
follow-up examinations in one of the four patients treated. There
was no change in the clinical status of the three other patients.
All patients will be followed for a total of five years. Dr. Johe
commented that the investigators are planning to add a second
cohort of four more patients to the study.
NSI-566/Ischemic Stroke: Dr. Johe presented
encouraging preliminary results from the first cohort of patients
in the Phase I NSI-566 feasibility study for treatment of paralysis
from stroke. The Phase I trial is designed to treat three cohorts
of three post-stroke patients each, with Cohort A receiving 5
injections of 40,000 cells each; Cohort B receiving 5 injections of
80,000; and Cohort C receiving 15 injections of 80,000 cells each.
The clinicians have completed dosing the second cohort. Dr. Johe
added that an innovative brain injection cannula, which can safely
inject higher doses of cells, was introduced into the study. The
trial is being conducted at BaYi Brain Hospital in Beijing, China.
Dr. Johe's presentation slides from the Phacilitate Cell &
Gene Therapy World conference are posted on the Investor Center of
the Company's website, www.neuralstem.com.
About Neuralstem
Neuralstem's patented technology enables the commercial-scale
production of multiple types of central nervous system stem cells,
which are being developed as potential therapies for many central
nervous system diseases and conditions.
Neuralstem's ability to generate neural stem cell lines from
human hippocampus, which were used for systematic chemical
screening for neurogenesis effect, has led to the discovery and
patenting of molecules that Neuralstem believes may stimulate the
brain's capacity to generate new neurons, potentially reversing
pathophysiologies associated with certain central nervous system
(CNS) conditions.
The company has completed Phase 1a and 1b trials evaluating
NSI-189, its first neurogenic small molecule product candidate, for
the treatment of major depressive disorder (MDD), and is expecting
to initiate a Phase 2 efficacy study for MDD in 2016.
Neuralstem's first stem cell product candidate, NSI-566, a
spinal cord-derived neural stem cell line, is under development for
treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has
completed two clinical studies, in a total of thirty patients,
which met primary safety endpoints. In addition to ALS, NSI-566 is
also in a Phase 1 study to treat paralysis due to chronic spinal
cord injury, as well as in a Phase 1 study to treat paralysis from
ischemic stroke.
Neuralstem's next generation 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)
protein. The treatment is currently in preclinical investigation
for Alzheimer's disease (AD). In animal study reported at the 2015
Annual Meeting of the American Neurological Association, the cells
improved cognition and reduced amyloid beta (Aβ) plaque load in AD
mice.
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 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, 2014, and Form 10-Q for the three
and nine months ended September 30,
2015, filed with the Securities and Exchange Commission
(SEC), and in other reports filed with the SEC.
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SOURCE Neuralstem, Inc.