Neuralstem Reports Third Quarter Financial Results And Provides Update On Clinical Programs And Business Highlights

ROCKVILLE, Md., Nov.9, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) reported its financial results for the three months and nine months ended September 30, 2012 and provided an update on clinical programs and business highlights.

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"In the third quarter, the company achieved three significant clinical milestones. The first was the completion of the eighteenth and final surgery in our ALS Phase I trial. All ALS trial assessments show the NSI-566 neural stem cells and intraspinal transplantation procedure, the first in the world, to be safe. The trial's principal investigator, Dr. Eva Feldman, said she believes we are seeing evidence of a treatment effect in some Phase I patients over a sustained period of time. We look forward to advancing to the next ALS trials, to increase both number of patients treated and NSI-566 dosage, and effectively evaluate efficacy. To that end, we are working diligently with our investigators to file an IND with the FDA for a Phase II ALS trial by year-end," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer.

"The second significant clinical milestone was approval to begin our ischemic stroke trial in China. Our collaborators in Beijing, at the world-class BaYi Brain Hospital are on schedule to start enrollment early in the first quarter for a combined Phase I/II clinical trial to treat motor deficits due to ischemic stroke with NSI-566. The first part of the study, Phase I, will be open-label and enroll up to 18 patients who will be assigned to one of three cohorts. Each cohort will receive ascending doses of NSI-566 directly into the brain at the stroke area (another first for Neuralstem), to define the maximal safe dose, before proceeding to the Phase II/proof-of-concept study to evaluate efficacy," said Dr. Johe. "One of several independent Neuralstem studies presented at The Society for Neuroscience's annual meeting demonstrated significant recovery of motor and neurological functions in ischemic stroke rats with NSI-566; a second ischemic stroke study demonstrated safety and feasibility in a chronic model in mini-pigs. Together, with the extensive human safety data established in our ALS trial, these two studies demonstrate strong proof-of-principle data that our NSI-566 cells are ready to test in humans to treat paralysis in stroke patients. A rat spinal cord injury study, reported in the peer-reviewed scientific journal CELL, demonstrated that NSI-566 cells induce regeneration of injured spinal cord axons into the graft and serve as a bridge to reconnect to gray matter motor neurons for many spinal cord segments below an injury, inducing significant recovery of motor functions."

Dr. Johe concluded: "The third significant clinical milestone was the FDA approval for dosing the second cohort of major depressive disorder patients in the Phase Ib trial of NSI-189. Our lead neurogenic drug, NSI-189 is a first-in-class orally active drug that stimulates new neuron growth and increased volume in the hippocampus, which we believe can help patients with MDD and other psychological and cognitive conditions. We are on track to complete the Ib, an ascending-dose, 28-day-cycle safety trial designed in collaboration with Dr. Maurizio Fava of Harvard University and Massachusetts General, during the first quarter of 2013."

Neuralstem's President and CEO Richard Garr added: "The third quarter of 2012 marked business milestones as well. We saw a major addition to our patent estate with U.S. patent number 8,236,299, with a patent life into 2030, titled: 'Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions.' This is significant in that it covers processes involved in our first potential transplantation product, including claims covering processes for dissociating our neural stem cells from central nervous system tissue; culturing the cells; expanding the cells in vitro and transplanting the cells into the spinal cord of a patient to treat a wide array of neurodegenerative conditions, including ALS."

Mr. Garr continued: "The company granted its first licenses for use of our proprietary Spinal Cord Delivery Platform and Floating Cannula. As the industry standard for delivering therapeutic agents to the spinal cord, we expect to continue to announce licenses of the surgical devices to both industry and academia as they now begin to explore the possibilities our technology has enabled. We are also continuing discussions for licensing and partnership opportunities for our neurogenic small molecule program, for which we are seeing strong interest. Our goal is to move NSI-189 and our preclinical library of additional novel neurogenic compounds forward in multiple indications, which range from Alzheimer's disease and anti-aging (nootropic) to chronic traumatic encephalopathy and post-traumatic stress disorder. We believe this can best be accomplished through partnering with industry."

Clinical Program and Business Highlights

Cellular Therapy: NSI-566 Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University Hospital

Cellular Therapy: NSI-566 Phase I/II Clinical Trial in Ischemic Stroke at BaYi Brain Hospital

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Neuralstem Reports Third Quarter Financial Results And Provides Update On Clinical Programs And Business Highlights