Neuralstem Investigator Presents New ALS NSI-566 Data at International Symposium on ALS/MND
Evidence of Long-Term Cell Survival
NIH Funding for Phase II
ROCKVILLE, Md., Dec. 10, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that Jonathon Glass , MD, Director of the Emory ALS Center, presented new data from the Phase I trial of Neuralstem's human spinal cord stem cells, NSI-566, in amyotrophic lateral sclerosis (ALS or Lou Gehrig 's disease) at the International Symposium on ALS/MND in Chicago, sponsored by the Motor Neurone Disease Association. In a Thursday presentation, "RESULTS OF PHASE 1 TRIAL OF SPINAL CORD TRANSPLANTATION OF NEURAL PROGENITOR CELLS IN ALS (THE NEURALSTEM, INC. TRIAL)," Dr. Glass revealed that researchers were able to establish the long-term survival of Neuralstem's transplanted spinal cord stem cells in autopsied patients, through a technology called DNA fingerprinting. Dr. Glass, who is the principal site investigator of the trial at Emory, also announced that the study team has received a grant from the National Institutes of Health (NIH) to cover a majority of the cost of an upcoming Phase II trial.
"We are quite pleased by our ability to perform all of the surgeries planned for the Phase I trial without evidence of significant surgical or medical complications, including those patients who received both lumbar and cervical transplantations," said Dr. Glass. "We can also report that we found evidence of cell survival in all of the patients who came to autopsy, including our first patient who died 30 months after transplantation.
This is very positive news, supporting our plan to accelerate this study by increasing the dose of stem cells delivered to the cervical spinal cord in the hopes of delaying respiratory failure and prolonging life. The next phase of the study has been partially funded by a generous grant from the National Institutes of Health, and we will begin once the FDA approves our new protocol," Dr. Glass concluded.
"This is a major finding," said Karl Johe , Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer. "There is currently no way to confirm the survival of the cells in patients while they are alive. Levels of functional recovery, or a slowdown in the progression of the disease in various patients, have given us reason to believe the cells have survived. Now, cell survival has been demonstrated by definitive evidence.
Among the six patients autopsied (five died of ALS disease progression and one, of unrelated heart failure), the survival period, from stem cell transplantation to death, ranged from 196 – 921 days. Five of these patients had discontinued all immune suppression medications for 57 – 638 days prior to death, but showed the stem cell DNA content in the range of 0.67% - 5.4% of total DNA in some spots of cord treated with the stem cells. There was no correlation of DNA content to survival period without immune suppression medication. These data, therefore, suggest that long-term immuno suppression of patients is not required for long-term survival of our cells, which points towards the feasibility of needing only transient immune suppression in future ALS trials," Dr. Johe concluded.
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 has recently treated the last patient 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 NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in 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 is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
For more information, please visit www.neuralstem.com or connect with us on Twitter and Facebook.
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, 2011 and the quarterly report on Form 10-Q for the period ended September 30, 2012.
SOURCE Neuralstem, Inc.
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