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Neuralstem (CUR): FDA Approval for the Phase 1 Trial of NSI-566

Neuralstem’s (CUR) patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. In August 2012, Neuralstem completed the final surgery of an FDA-approved Phase I NSI-566 safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease & has been awarded orphan drug designation by the FDA for the treatment of ALS.

Today CUR announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. Open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury.

Karl Johe, Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer, commented:

The company is both pleased and excited to begin this long-awaited trial to treat spinal cord injury patients with our spinal cord cells, NSI-566. ┬áIn August, in the peer-reviewed journal ‘Cell,’ compelling evidence was presented that the cells can ‘bridge the gap’ in a severed spinal cord model and return functionality.
This will be the first stem cell trial to attack the problem that way, as well as the first to treat chronic spinal cord injury patients. In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial. That trial has demonstrated that the surgical route of administration and the cells are safe and, well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566.

CUR’s cash burning rate is about 10MM per year. New trial will require additional fundings even after $7MM cash infusion from last year offering. Short sale of CUR is the prefferable option in the expectations of the second offering