Neuralstem Announces First Patient Treated in ALS Stem Cell Trial
January 21 2010 - 6:00AM
PR Newswire (US)
ROCKVILLE, Md., Jan. 21 /PRNewswire-FirstCall/ -- Neuralstem, Inc.
(NYSE Amex: CUR) announced that the first ALS patient was treated
with its spinal cord stem cells yesterday at the Emory ALS Center
at Emory University, in Atlanta, GA. A total of up to 18 patients
is planned to be treated in this first U.S. clinical trial to
evaluate human neural stem cells for the treatment of ALS
(Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). ALS
affects roughly 30,000 people in the U.S., with about 5,600 new
diagnoses per year, according to the ALS Association. (Logo:
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO ) "The
treatment of the first patient with our spinal cord stem cells
represents a significant milestone for the Company," said
Neuralstem President and CEO, Richard Garr. "Our scientists have
worked tirelessly to bring our discovery of adherent neural stem
cells from the bench to the bedside," said Dr. Karl Johe, Chairman
of the Board and Chief Scientific Officer at Neuralstem, and the
inventor of the technology. "This trial aims to establish the
safety and feasibility of using our cells to treat ALS. For now, we
are focused on the safe and speedy recovery of the first patient,
and we wish to thank him and his family for their courageous
participation in the trial." About the Trial This Phase I trial,
which will primarily evaluate safety of the cells and the surgery
procedure, is designed to enroll up to 18 ALS patients, at varying
stages of the disease progression. They will receive spinal
injections of Neuralstem's patented human neural stem cells as a
one-time treatment. The FDA has approved the first stage of the
trial, which consists of 12 patients who will receive five-to-ten
stem cell injections in the lumbar area of the spinal cord. The
patients will be examined at regular intervals post-surgery, with
final review of the data to come about 24 months later. The overall
Principal Investigator (PI) for the Neuralstem ALS trial program is
Dr. Eva Feldman, M.D., Ph.D., Director of the University of
Michigan Health System ALS Clinic and the Program for Neurology
Research & Discovery. The Emory ALS Center has posted the
relevant trial information for patients on its website at
http://www.neurology.emory.edu/ALS/Stem%20Cell.html. 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. 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. Pre-clinical work has
shown that Neuralstem's cells extended the life of rats with ALS
(as reported in the journal TRANSPLANTATION, October 16, 2006, 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 December 31, 2008 and the quarterly report
on form 10-Q for the period ended September 30, 2009.
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO
http://photoarchive.ap.org/ DATASOURCE: Neuralstem, Inc. CONTACT:
Richard Garr, President of Neuralstem, Inc., +1-301-366-4960; or
Investor Relations, Dan Schustack of CEOcast, Inc.,
+1-212-732-4300; or Media, Deanne Eagle of Planet Communications
for Neuralstem, Inc., +1-917-837-5866 Web Site:
http://www.neuralstem.com/
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