January 21, 2010
ALS Patient Treated With Spinal Cord Stem Cells
Neuralstem, Inc. 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 are 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.
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.
On the Net:
- 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
- Neuralstem, Inc.