Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update

ROCKVILLE, Md., March 15, 2013 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) today provided an update on its clinical trial programs and reported its 2012 financial results for the year ended December 31, 2012.

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"2012 saw the company achieve success in all of its Phase I clinical trial objectives," said Karl Johe, Ph.D., Neuralstem's Chairman of the Board and Chief Scientific Officer. "We have been able to demonstrate the safety and tolerability of Neuralstem's novel core technologies, from intraspinal transplantation procedures, to the cells themselves in ALS patients, as well as our NSI-189 neurogenic small molecule drug in healthy volunteers. Additionally, we believe we have seen evidence of a treatment effect in some NSI-566 cell therapy patients over a sustained period of time, as measured by levels of functional recovery and a slowdown in the progression of ALS. In spinal cord injury, a leading peer-reviewed scientific journal, 'CELL,' published compelling evidence that NSI-566 cells can 'bridge the gap' in a severed spinal cord animal model and return functionality.We have recently been approved by the FDA to commence a trial treating chronic spinal cord injury patients.

A highlight of 2012 was the completion of our ground-breaking ALS Phase I trial. Following the last treatment of the final cervical cohort of return patients in August, our collaborators, University of Michigan's Dr. Eva Feldman and Emory University's Dr. Jonathan Glass, presented trial data that showed promise of a treatment effect for ambulatory ALS patients as well as definitive DNA-fingerprint evidence of long-term NSI-566 cell survival," continued Dr. Johe. "These positive data support our plan to 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 depression patients in our ongoing NSI-189/major depressive disorder (MDD) Phase Ib trial. Dosing has now increased from 40 mg. q.d.(once/day) for 28 days, which had been shown to be well-tolerated and safe in the first cohort, to 40 mg. b.i.d.(twice/day) for 28 days. Dosing of all patients in the second cohort will be completed this month and, pending FDA approval, we will commence dosing the final cohort."

Neuralstem's President and CEO Richard Garr added, "Neuralstem continued to strengthen its patent estate in 2012.Among the highlights, U.S. Patent number 8,236,299 includes claims covering processes for dissociating our neural stem cells from CNS 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, chronic and acute spinal cord injury, and stroke. Both the substance and life of this patent (into 2030) are reflective of the Intellectual Property value we are creating in our cell therapy programs.Additionally, during the past 12 months we have executed the first two out-licenses of our spinal platform cell therapy technology."

"Dr. Johe and I would like to extend our continued deep appreciation to our patients, their families and caregivers, our world-class clinical collaborators, and the Neuralstem team for enabling positive, ground-breaking clinical work which has now positioned us to move forward," added Garr.

Business Highlights for 2012

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

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Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update