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Neuralstem Reports Third Quarter Financial Results And Provides Business And Clinical Update
Date:11/12/2013

rological Association, recently presented complete Phase I NSI-566/ALS trial data at the annual ANA meeting, which  showed a clear slowing of disease progression or actual improvement for more than 700-to-approximately-850 days post-surgery, in six non-bulbar ALS  patients who were treated early in the course of their disease. All patients in Phase II are also ambulatory and within approximately two years of the onset of symptoms of the disease," said Dr. Johe. "The results from the complete Phase I data will be made public after they are published in a peer-reviewed scientific journal anticipated later this year.

"Looking ahead, our NSI-566/stroke Phase I/II trial at BaYi Brain Hospital, in Beijing, is expected to be underway later in the fourth quarter. This trial will treat with one-time intracerebral injections of cells directly into the ischemic stroke area," continued Dr. Johe. "The first phase will determine the maximum safe dose in up to 18 patients, and is expected to be completed in seven or eight months. Phase II will advance to a multicenter, randomized, controlled single-blind study with up to 100 patients, and is designed to evaluate efficacy and safety for clinical proof-of-concept. Also, of note, we continue to make progress towards commencement of the FDA-approved NSI-566/chronic spinal cord injury Phase I trial in the first quarter of 2014. This trial, which will treat eight patients with T2-T12 complete paralysis, uses the same cells and methodology as our ALS trial.  

"The recent publication of an animal study by our collaborators at the University of California, Irvine, provided proof of principle for NSI-566 in the amelioration of cognitive dysfunction induced by brain irradiation, a common treatment for brain cancer in humans. In the study, rats injected with the cells two days after brain irradiation demonstrated a reduction in radiation-induced cognitive dysfunction. This is an important validation for the ongoi
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