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Neuralstem Receives FDA Approval to Dose Patients in Cervical Region in Ongoing ALS Trial
Date:10/24/2011

o 18 patients. All of the first 12 patients have been transplanted in the lumbar (lower back) region of the spine. The trial will now progress to the last six patients. The first three of these will receive unilateral injections in the cervical region of the spine. The next three will receive bilateral injections in the cervical region.

About Neuralstem

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 conducting an ongoing 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.  Neuralstem's first small molecule compound, NSI-189 is currently in a Phase I FDA-approved safety trial in major depressive disorder.  The Phase Ib portion of the trial, in depressed patients, is expected to commence later this year. Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

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SOURCE Neuralstem, Inc.
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Related medicine technology :

1. Dr. Eva Feldman, Principal Investigator, Presents Interim Data on Neuralstem ALS Trial
2. Neuralstem Announces Notice of Allowance for Two Additional Neurogenic Compound Patents
3. Neuralstem Updates NSI-189 Major Depression Trial
4. Dr. Eva Feldman, Principal Investigator, Presents Interim Safety Results for Neuralstem ALS Trial
5. Neuralstem Updates ALS Clinical Trial Progress
6. Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS
7. Neuralstem Receives FDA Approval to Commence Drug Trial for Major Depression
8. Neuralstems Human Stem Cells Integrate into Nervous System of Rats with Animal Model of ALS
9. Neuralstems ALS Trial on Clinical Hold
10. Neuralstem Licenses Cleveland Clinic Spinal Cord Injection Technology
11. Neuralstem Announces Issuance of Core Technology Patent in Europe
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