ROCKVILLE, Md., April 16, 2014 /PRNewswire/ -- Neuralstem, Inc.
(NYSE MKT: CUR) announced that the Institutional Review Board of
the University of California, San
Diego, School of Medicine has approved the Phase I safety
trial to treat chronic spinal cord injury (cSCI) with its NSI-566
stem cells. The NSI-566/cSCI Phase I trial will enroll patients
with thoracic spinal cord injuries (T2-T12) who have an American
Spinal Injury Association (AIS) A level of impairment, between
one and two years after injury. AIS A impairment, which is complete
paralysis, refers to a patient with no motor or sensory function in
the relevant segments at and below the injury. The trial, which
already has FDA approval, and has a one-year completion goal, will
be under the direction of principal investigator (PI) Joseph Ciacci, MD, UC San Diego School of
Medicine and neurosurgeon at UC San Diego Health System. Much of
the pre-clinical work with the NSI-566 cells in spinal cord injury
was conducted at UC San Diego School of Medicine by Martin Marsala, MD, professor in the Department
of Anesthesiology, who will be another study investigator.
"Moving our spinal cord cells into human trials for a second
indication in the U.S. is a major step forward for the company,"
said Karl Johe PhD, Neuralstem's Chairman of the Board and Chief
Scientific Officer. "We have demonstrated that the surgical route
of administration is safe and robust; that the cells survive
transplantation and are biologically active in the patients, and
that both the cells and the surgery are well-tolerated and safe. In
animals, we have shown compelling proof-of-principle of return of
significant function. With 30 successful spinal surgeries completed
in our ALS trials, we feel we are ready to tackle spinal cord
injury and are excited to begin this ground-breaking study. We wish
to thank and acknowledge the support of our collaborators
at UCSD, without whom this trial would not be possible."
In a peer-reviewed study, published in the journal, STEM CELL
RESEARCH AND THERAPY, in May, 2013, rats transplanted with NSI-566
stem cells three days after a spinal cord injury at L3 (lumbar 3),
showed improvement along several measures of motor function and a
reduction of spasticity. The study demonstrated that intraspinal
grafting of NSI-566 cells during the acute phase of a spinal cord
injury could represent a safe and effective treatment that
ameliorates post-injury motor and sensory deficits.
In a separate peer-reviewed study, published in the journal,
CELL, in August, 2012, rats with surgically transected spinal cords
transplanted with Neuralstem's NSI-566 stem cells, recovered
significant locomotor function, regaining movement in all lower
extremity joints. Furthermore, the cells turned into neurons which
grew a "remarkable" number of axons that extended for "very long
distances," bridging above and below the point of severance. These
neurons also appeared to make reciprocal synaptic connectivity with
the host rat spinal cord neurons in the gray matter for several
segments below the injury.
Patients wishing to find out about the trial should contact the
principal investigator's office: 619-471-0798.
About Chronic Spinal Cord Injury
There are more than 10,000 new spinal cord injuries (SCI) in the
US each year. At the time of a recent survey done by the
Christopher & Dana Reeve Foundation, there were approximately
840,000 people living with chronic SCI, which refers to patients in
whom paralysis persists and becomes permanent. According to the
National Spinal Cord Injury Association, 85% of SCI patients who
survive the first 24 hours are still alive 10 years later.
About Neuralstem
Neuralstem's patented technology enables the production of
neural stem cells of the brain and spinal cord in commercial
quantities, and the ability to control the differentiation of these
cells constitutively into mature, physiologically relevant human
neurons and glial cells. Neuralstem's NSI-566 spinal cord-derived
stem cell therapy is in Phase II clinical trials for amyotrophic
lateral sclerosis (ALS), often referred to as Lou Gehrig's disease. Neuralstem has been
awarded orphan status designation by the FDA for its ALS cell
therapy.
In addition to ALS, the company is also targeting major central
nervous system conditions with its NSI-566 cell therapy platform,
including spinal cord injury and ischemic stroke. The company has
received FDA approval to commence a Phase I safety trial in chronic
spinal cord injury.
Neuralstem also maintains the ability to generate stable human
neural stem cell lines suitable for systematic screening of large
chemical libraries. Through this proprietary screening technology,
Neuralstem has discovered and patented compounds that may stimulate
the brain's capacity to generate neurons, possibly reversing
pathologies associated with certain central nervous system
conditions. The company has completed a Phase I safety trial
evaluating NSI-189, its first neurogenic small molecule product
candidate, for the treatment of major depressive disorder (MDD).
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.
Logo -
http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO
SOURCE Neuralstem, Inc.