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Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update
Date:3/15/2013

accelerate the ALS trial in Phase II, by increasing both the number of NSI-566 cells and number of injections delivered to the cervical spinal cord, where we believe we can most positively affect patients' lives by sustaining their breathing capacity. Our proposed Phase II trial protocol, which would be simultaneously conducted at Emory University Hospital and University of Michigan, is currently in review at the FDA. The National Institutes of Health and ALSA have committed to generous grants totaling nearly $3,000,000 in funding for this next phase of the study, pending FDA approval. We join with our esteemed collaborators in being eager to move forward to future trial phases to examine therapeutic efficacy of NSI-566. We hope to commence the ALS Phase II trial in the second quarter."

Dr. Johe continued, "2013 promises to be a transformative year for the company, with five NSI-566 cell therapy trials planned. The two new U.S. trials will be the ALS Phase II, and the recently FDA-approved Phase I in chronic spinal cord injury. We hope to have agreements with multiple sites for the Phase I chronic spinal cord injury trial in place by the end of the 2nd Quarter and then begin the transplantations. Internationally, our ischemic stroke trial is expected to commence in Beijing at world-class BaYi Brain Hospital in the coming weeks, through our subsidiary, Neuralstem China. A planned ALS combined Phase I/II is expected to take place in Mexico City, pending finalization of a partnership agreement. Later this month, we expect to file an IND for an acute spinal cord injury trial in Seoul, South Korea, which we anticipate conducting with our partner, CJ CheilJedang.

"2012 also saw advances through the clinic for NSI-189, the company's lead compound in our first-in-class neurogenic small molecule drug," Dr. Johe commented further. "The FDA approved dosing the second cohort of eight dep
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SOURCE Neuralstem, Inc.
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