Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial
September 21 2009 - 7:00AM
PR Newswire (US)
ROCKVILLE, Md., Sept. 21 /PRNewswire-FirstCall/ -- 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 commence a Phase I trial to treat Amyotrophic
Lateral Sclerosis (ALS or Lou Gehrig's disease) with its spinal
cord stem cells. (Logo:
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )
Neuralstem is the first company to commence a stem cell trial to
treat ALS. The trial will study the safety of Neuralstem's cells
and the surgical procedures and devices required for multiple
injections of Neuralstem's cells directly into the grey matter of
the spinal cord. The FDA's approval represents a significant step
toward delivering regenerative medicine directly to damaged neural
cells in humans. ALS affects roughly 30,000 people in the U.S.,
with about 7,000 new diagnoses per year. Neuralstem CEO and
President, Richard Garr, stated, "The beginning of our clinical
trial program is a major step towards achieving Neuralstem's goal
of treating ALS, a fatal neurodegenerative disease for which
currently there is no effective treatment or cure. While this trial
aims to primarily establish safety and feasibility data in treating
ALS patients, we also hope to be able to measure a slowing down of
the ALS degenerative process. This trial will be in the extremely
capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director of the
University of Michigan Health System ALS Clinic and the Program for
Neurology Research & Discovery, and Dr. Jonathan Glass,
Director of the Emory Neuromuscular Laboratory and Director of the
Emory ALS Center, world-renowned for their study and treatment of
ALS patients. We believe that there is no better team to conduct
this study for us," said Garr. Their participation is subject to
formal IRB approval by their institutions. "We are very excited
about this clinical trial," said Dr. Eva L. Feldman, who will
direct the Neuralstem clinical trial program for ALS. "This is a
major advancement in what still could be a long road to a new and
improved treatment for ALS. ALS is a terrible disease that
ultimately kills by paralysis," said Feldman, who also directs the
A. Alfred Taubman Medical Research Institute. "In work with
animals, these spinal cord stem cells both protected at-risk motor
neurons and made connections to the neurons controlling muscles. We
don't want to raise expectations unduly, but we believe these stem
cells could produce similar results in patients with ALS," Dr.
Feldman concluded. About the Trial The ALS patients will be treated
through spinal injections of its patented human neural stem cells.
This first trial, which will primarily evaluate safety of the cells
and the surgery procedure, will ultimately consist of 18 ALS
patients with varying degrees of the disease. 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. Neuralstem expects to conduct the trial at Emory University
with Dr. Jonathan Glass, M.D., Director of the Emory Neuromuscular
Laboratory and Director of the Emory ALS Center, as site Principal
Investigator (PI) and with Dr. Nicholas Boulis, M. D. performing
the neurosurgery. The overall PI for the 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. 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 plans
to initiate a Phase I clinical trial to treat ALS with its stem
cells. 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 Neuralstem's cells to extend
the life of rats with ALS (as reported 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 June 30,
2009. http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO
http://photoarchive.ap.org/ DATASOURCE: Neuralstem, Inc. CONTACT:
Company, Richard Garr, President, Neuralstem, Inc.,
+1-301-366-4960; or Media, Deanne Eagle, Planet Communications,
+1-917-837-5866; or Investor Relations, Dan Schustack, CEOcast,
Inc., +1-212-732-4300 Web Site: http://www.neuralstem.com/
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