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8-K - PALISADE BIO, INC. | v205766_8-k.htm |
Exhibit
99.01
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Susan Roush, Investor
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NEURALSTEM
RECEIVES FDA APPROVAL TO COMMENCE DRUG TRIAL FOR MAJOR DEPRESSION
ROCKVILLE, Maryland,
December
16,
2010 – Neuralstem, Inc.
(NYSE Amex: CUR) today
announced that the U.S. Food and Drug Administration (FDA) has approved its
Investigational New Drug
(IND) application to initiate a Phase Ia safety trial to test
NSI-189, its first small molecule compound, in major depression. NSI-189 is a proprietary new chemical entity
discovered by Neuralstem that stimulates new neuron growth in the
hippocampus, an area of the brain that is believed to be involved in depression
and other diseases, such as Alzheimer’s disease.
“The
commencement of the first trial in our small molecule platform represents a
major milestone for Neuralstem,” said Richard Garr, Neuralstem President &
CEO. “In addition to our ongoing programs in cell therapeutics, we are now
advancing a new class of orally administered drugs that recruit endogenous
neural stem cells. NSI-189 is the first in this class.”
“Today’s
antidepressants are based on a theory of serotonin deficiency,” explained Karl
Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem’s Board of
Directors. “A new theory is emerging that chronic stress can lead to hippocampal
atrophy and eventually to depression. NSI-189 appears to help the brain repair
itself, generating new neurons and protecting against damage. This neurogenic
approach is completely novel in the treatment of CNS diseases.”
About
NS-189
NS-189 is
the first in a class of compounds that Neuralstem plans to develop into orally
administered drugs.
In mice,
NSI-189 both stimulated neurogenesis of the hippocampus and increased its
overall volume as well. Additionally, NSI-189 stimulated neurogenesis of human
hippocampus-derived neural stem cells in-vitro. Therefore, NSI-189 may reverse
the human hippocampal atrophy seen in major depression and schizophrenia. This
program has received significant support from both the Defense Advanced Research Projects
Agency (DARPA) and the National Institutes of Health
(NIH).
The Neuralstem small molecule platform
results from discoveries made through Neuralstem’s ability to generate stable human
neural stem cell lines suitable for screening large chemical libraries. The
platform complements Neuralstem’s cell therapy platform, in which brain and
spinal cord stem cells are transplanted directly into diseased areas to repair
and/or replace diseased or dead cells.
About the
Trial
This
Phase Ia trial will test a single dose of NSI-189 in healthy patients. If the
safety endpoints are met, the trial will commence to the Ib phase, testing the
safety of escalating doses of daily administration for 28 days in depressed
patients. The entire Phase I trial is expected to be approximately one year in
duration.
Further
information will be available on the Neuralstem website when recruitment for the
trial begins.
About
Neuralstem
Neuralstem's patented technology enables
the ability to produce neural stem cells of the human 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
glia. Neuralstem is in a FDA-approved Phase I safety clinical trial for
Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's
disease.
In addition to ALS, the company is also
targeting major central nervous system diseases, including traumatic spinal cord
injury, ischemic spastic paraplegia, and Huntington's disease. The company has
also submitted an IND (Investigational New Drug) application
to the FDA for a Phase I safety trial in chronic spinal cord
injury.
Neuralstem also has the ability to
generate stable human neural stem cell lines suitable for the 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 new neurons, possibly reversing the pathologies
of some central nervous system conditions. The company has
been approved to commence a Phase Ia
safety trial evaluating NSI-189, its first small molecule
compound, for the treatment of major depression. Additional
indications could include schizophrenia, Alzheimer's disease,
traumatic brain injury, posttraumatic stress syndrome, and
stroke.
For more information, please go to
www.neuralstem.com http://www.neuralstem.com
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, 2009,
and in its quarterly report on Form 10-Q for the period ended September 30,
2010.
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