Source : BUSINESS WIRE
ROCKVILLE, Md.--(BUSINESS WIRE)--Jun. 4, 2009--
Neuralstem, Inc. (NYSE Amex: CUR) announced today it received a notice
of allowance from the U.S. Patent and Trademark Office (USPTO) for a
patent on four new chemical entities that boost the generation of new
neurons. Patent application 12/049,922, entitled “Use of Fused
Nicotinamides to Promote Neurogenesis,” claims four chemical entities
and any pharmaceutical composition including them.
“We are extremely pleased and proud to be getting this patent coverage,”
said Neuralstem President and CEO Richard Garr. “The ability to promote
neurogenesis—the birth of new neurons in the adult brain—has recently
been a focus of intense research by scientists and pharmaceutical
companies worldwide. These four compounds, with potent demonstrated
neurogenic activity, are first-in-class compounds, were discovered
entirely in-house and are owned by the Company. These are the only drugs
we are aware of with the demonstrated ability to stimulate neurogenesis
of normal adult brain cells, which indicates that they are truly
neurogenic.”
The patent discloses potent activities by these chemicals to boost the
generation of new neurons from human neural stem cells in-vitro as well
as from the hippocampus of normal adult rodent brains. The patent
further discloses that these chemicals may be useful in treating a
number of major central nervous system (CNS) diseases including
depression, Alzheimer’s disease, stroke and traumatic brain injury,
among others.
“The hippocampus is the area of the brain that is central to learning,
memory and emotion,” Dr. Karl Johe, Ph.D., Neuralstem Chairman and Chief
Scientific Officer, explained. “The hippocampus is also the only area in
the brain that is known to normally generate new neurons. In diseases
such as major depression, Alzheimer’s disease, stroke and traumatic
injury, the hippocampus is critically atrophied or injured. Utilizing
our unique technology, which allows us to reproduce the neurogenesis
from human hippocampal stem cells in-vitro, we were able to screen large
chemical libraries to identify these potent compounds that may reverse
certain CNS pathologies by stimulating the brain’s own capability to
generate new neurons.”
Richard Garr added, “We expect to be in a Phase I safety trial for
treatment of major depression with our lead compound from this group by
early next year.” We already have synthesized this compound on a large
scale. It is orally active, with good pharmacokinetic profiles in both
the blood and brain, and no toxicity even at very high doses. We also
expect to be testing these compounds for stroke, traumatic brain injury
and other major indications.”
About Neuralstem, Inc.
Neuralstem's patented technology enables, for the first time, 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 into mature, physiologically relevant human neurons and
glia. The Company is targeting major central nervous system diseases
including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury,
Huntington’s disease and Amyotrophic Lateral Sclerosis (ALS), often
referred to as Lou Gehrig's disease. Neuralstem’s IND is under review
with the FDA for ALS. ALS is a progressive, fatal neurodegenerative
disease that affects nerve cells in the brain, leading to the
degeneration and death of the motor neurons in the spinal cord that
control muscle movement. ALS affects roughly 30,000 people in the U.S.,
with about 7,000 new diagnoses per year. Pre-clinical work has shown
Neuralstem’s cells to extend the life of rats with ALS (as reported the
journal TRANSPLANTATION, in collaboration with Johns Hopkins
University researchers), and also reversed paralysis in rats with
Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE; June 29,
2007, in collaboration with researchers at University of California San
Diego).
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 March 30, 2009.
Source: Neuralstem, Inc.
Neuralstem, Inc.
Richard Garr, President 301-366-4960
Ina
McGuinness, Investor Relations 310-954-1100
Deanne Eagle, Media
917-837-5866