First Patient Dosed in Cervical Region in NeuralStem Inc. ALS Stem Cell Trial
Published: Nov 23, 2011
ROCKVILLE, Md., Nov. 23, 2011 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the first patient to receive stem cells in the cervical (upper back) region of the spine was treated on Friday in its ongoing trial to test the safety of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 13 is the first in the trial to be dosed in this region. It is also the first time surgeons have gone into the gray matter of the cervical region. The initial twelve patients in the trial all received stem cell transplants in the lumbar (lower back) region of the spinal cord only. Details about the surgery and interviews with the doctors were highlighted in a story on CNN (11/22/11) and can be viewed at http://www.neuralstem.com/neuralstem-in-the-news.
"We conducted the first cervical area surgery into a patient in our ALS trial," said Eva Feldman, MD, PhD, Dr. Feldman, Director of the A. Alfred Taubman Medical Research Institute, the Director of Research of the ALS Clinic at the University of Michigan Health System and an unpaid consultant to Neuralstem. "The ultimate goal of transplanting cells into this region is to preserve or even enhance breathing capacity for the patients," Dr. Feldman explained. "This treatment is essential to improve the quality of ALS patient lives and potentially lengthen them."
"We are thrilled to have advanced to this crucial stage in our ALS trial, where we can deliver our cells to the cervical region, where they could possibly support life-sustaining functions," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "Successfully intervening in the cervical region entails enhanced risk, but also the possibility of dramatically enhanced benefit to the patients. We remain extremely indebted to the team at Emory, where the trial is being conducted, and to the brave patients in our trial and their families."
About the Trial
The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. All of the first 12 patients have been transplanted in the lumbar (lower back) region of the spine. The trial has now progressed to the final six patients, all of whom will be treated in the cervical (upper back) region of the spine. The first patient in the cervical cohort was treated on November 18, 2011. The entire 18-patient trial concludes six months after the final surgery.
Neuralstem's patented technology enables 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 constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and Huntington's disease. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has completed an FDA-approved Phase Ia safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depression, and expects to receive Phase Ib trial approval before year end. Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.
For more information, please go to www.neuralstem.com.
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, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.
SOURCE Neuralstem, Inc.