Neuralstem Announces First Patient Treated in ALS Stem Cell Trial
Download image 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.
"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
Emory ALS Center: ALS Research.
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.
SOURCE Neuralstem, Inc.
