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Dr. Eva Feldman, Principal Investigator, Presents Interim Safety Results for Neuralstem ALS Trial
Date:4/12/2011

ression, which were resolved via dose adjustment in two cases and discontinuance in the third. One patient experienced a pulmonary embolism 19 days post-surgery secondary to an iliac vein thrombosis, unlikely related to the cells. All adverse events were resolved. In the group of ambulatory patients, all three remain ambulatory and experienced no serious adverse events secondary to surgery.  

"It has been 15-to-4 months since the first nine patients have received the cells," said Karl Johe, Ph.D., Chief Scientific Officer and Chairman of Neuralstem's Board of Directors.  "There have been no adverse reactions possibly or probably or definitely related to the cells.  This indicates that the trial is proceeding as smoothly as can be hoped for. It is designed for transplantation to progress up to the cervical region of spinal cord as safety is demonstrated in the lumbar region," Dr. Johe continued. "With SMB and FDA review of the safety data from the 12 patients due to be completed in the next month, we hope to begin transplanting ALS patients in the cervical region this summer."

"This is significant and, we believe, compelling safety data," said Richard Garr president and CEO of Neuralstem. "It represents the first safety results from the world's first ALS neural stem cell trial, as well as the first data from Neuralstem's ongoing clinical programs. We believe it also validates our proprietary Spinal Injection Platform for the safe intraspinal delivery of our cells.  We  remain deeply indebted to the patients and their families who are participating in the study."

About the Study

Safety results were presented on nine patients in an ongoing Phase I study to evaluate the safety of Neuralstem's spinal cord stem cells (HSSC's), as well as the transplantation technique, in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease).

Of these nine patients, the first six (Cohort A) were a
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SOURCE Neuralstem, Inc.
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