ROCKVILLE, Md., May 9, 2012 /PRNewswire/ -- Neuralstem, Inc. (CUR) today reported its financial results for the three months ended March 31, 2012 and provided a business and clinical update.

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"In the first Quarter of 2012, we entered the final cohort of our Phase I clinical trial in ALS at Emory University Hospital. We are encouraged with the recent approval by the FDA to amend the trial protocol to bring back previously transplanted patients for additional dosing. These patients, who have each received ten lumbar injections earlier in the trial, may now receive an additional five cervical injections. These three patients in our ALS Phase I trial will become the first patients to receive neural stem cell injections up the full length of the spinal cord," said Karl Johe, PhD, chairman of the board and chief scientific officer of Neuralstem, Inc. "These patients are currently 15 to 17 months out from their original surgeries, so we are further encouraged by the fact that their disease progression has been slow enough that they can still be considered for these additional cervical injections. These segments of the spinal cord control breathing, and we believe that multiple injections in the cervical region may be the most effective way to help ALS patients. In order to be eligible, these three patients must meet the same inclusion criteria as new patients into the trial both before and at the time of surgery."

Dr. Johe continued, "This year will also see the start and finish of our neuroregenerative small molecule NSI-189 Phase Ib trial to treat major depressive disorder. This is a novel orally active drug that stimulates new neuron growth in the hippocampus which we believe can help patients with major depressive disorder. We are finalizing the preparations for the first of three cohorts of eight patients each that are scheduled to demonstrate the safety of escalating doses of daily administration of NSI-189 during a 28-day cycle. Dr. Maurizio Fava of Harvard University and Massachusetts General helped to design the trial and we thank him for his efforts.

"Internationally, we expect to commence a combined Phase I/II/III clinical trial for chronic motor disorders from stroke at BaYi Brain Hospital in Beijing through our wholly owned subsidiary, Neuralstem China later in the year. We are currently engaged in test runs at our facility in Suzhou, China where we will manufacture the neural stem cells for the trial," concluded Dr. Johe.

Neuralstem's President and CEO Richard Garr added, "This New Year has seen us actively engaged in licensing discussions for our proprietary surgical device, invented by our ALS surgeon, Dr. Nicholas M. Boulis, with both the industry and Academia. We believe it will be the industry standard for such intraspinal procedures.

"We continue to work with our partner Sumitomo's Summit Pharmaceuticals International Corporation with the goal of licensing NSI-189 to a Japanese pharmaceutical company for development of the Japanese market this year," Mr. Garr continued. "We also continue to see strong interest in co-development opportunities for our preclinical library of additional patented novel neuroregenerative compounds. The company is committed to finding the right partner to move these preclinical compounds forward."

Clinical Program and Business Highlights

Cellular Therapy: Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University Hospital

Corporate News

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Neuralstem Reports First Quarter Financial Results And Provides Business And Clinical Update