ROCKVILLE, Md., Dec. 18 /PRNewswire-FirstCall/ -- Neuralstem, Inc.
(NYSE Alternext US: CUR) announced this morning that it has filed an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) to begin a clinical trial to treat amyotrophic lateral
sclerosis (ALS or Lou Gehrig's disease). The Company is planning to treat ALS
patients through spinal injections of its stem cells via its patented Human
Neural Stem Cell technology.
"Like all first human trials, this proposed trial is primarily designed to
test the safety and feasibility of both our stem cells and our method of
delivering the cells to the spinal cord in ALS patients," said Neuralstem CEO
and President, Richard Garr. "We are also proposing secondary endpoints which
we hope will be able to measure a slowing down of the degenerative process."
ALS is a progressive 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 the muscles. Loss of the ability to initiate and
control muscle movement ends in paralysis and, ultimately, death. ALS affects
roughly 30,000 people in the U.S., with about 7,000 new diagnoses per year.
Neuralstem expects to conduct the trial at Emory University with Dr.
Johnathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and
Director of the Emory ALS Center, as site Principal Investigator (PI). Dr. Eva
Feldman, M.D., Ph.D., Head of the A. Alfred Taubman Medical Research Institute
and the De Jong Professor of Neurology at the University of Michigan Medical
School, will be the overall PI for the ALS trial program. Formal approvals
from these institutions to conduct the trial can come only after FDA approval
of the trial protocol.
"The filing of this IND is an important event for Neuralstem," said Garr,
"but it marks only the beginning of a process which includes working together
with the FDA to approve the first human ALS stem cell trial; refining our
understanding of how to optimize delivery of our cells into patients; and
ultimately delivering a new treatment for patients with this currently
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. Major Central Nervous
System diseases targeted by the Company with research programs currently
underway include: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury,
Huntington's disease and ALS. The Company filed an IND (Investigational New
Drug) application with the FDA for ALS clinical trials in December, 2008, and
has entered into a collaborative agreement with Albert-Ludwigs-University, in
Freiburg, Germany, to develop clinical trials for Huntington's disease.
In pre-clinical work, the company's cells have extended the life of rats
with ALS (Lou Gehrig's disease) 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 on 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-KSB for the year ended December 31, 2007 and the quarterly report on
form 10-Q for the period ended September 30, 2008.
SOURCE Neuralstem, Inc.
CONTACT: Richard Garr, President of Neuralstem, Inc., +1-301-366-4960;
Media, Deanne Eagle of Planet Communications for Neuralstem, Inc.,
+1-917-837-5866; Investor Relations, Ina McGuinness of ICR, Inc.,
+1-310-954-1100, or Steve Chizzik of Equity Communications, +1-908-688-9111,
both for Neuralstem, Inc.