"This is another critical milestone for the company," said Richard Garr, Neuralstem President and CEO. "We believe the FDA approval of a trial for a second indication for our NSI-566 cells demonstrates an increasing level of comfort at the FDA with our technology and acknowledges the positive strides being made in the ALS trial. Our goal for this SCI trial is to transplant and collect the 6 month data for all patients within a one-year timeframe.
The approval of this trial is also a demonstration of our product development strategy," Mr. Garr continued. "While we can create cell products from various regions of the CNS that might be applicable to all manner of indications, we have chosen to address multiple indications where the same cell product is applicable. This allows us to leverage the product manufacturing and safety data created in each trial with the next. Along those lines, we will begin dosing patients with NSI-566 to treat paralysis from stroke in the next month, in China, and we are preparing for a trial with NSI-566 to treat acute spinal cord injury patients in Korea this summer. We are also currently in discussions with the FDA over the design and scope of our Phase II trial for ALS with NSI-566. As we begin to create proof-of-principle data in multiple indications, we are also creating additional NSI-556 safety data across indications and borders."
In a September study published in the journal CELL ( http://www.cell.com/abstract/S0092-8674%2812%2901018-5), paralyzed rats transplanted with NSI-566 stem cells recovered significant locomotor function, regaining movement in all lower extremity joints. Additionally, the transplanted neural stem cells turned into neurons which grew multiple axons. These axons extended over 17 spinal segments above and below the point of severance, where made reciprocal synaptic connectivity with the host spinal cord neurons, improving electrophysiological and functional outcome
About Chronic Spinal Cord InjuryThere are more than 10,000 new spinal cord injuries (SCI) in the US each year. At the time of a recent survey done by the Christopher & Dana Reeve Foundation, there were approximately 840,000 people living with chronic SCI, which are patients in whom paralysis persists and becomes permanent. According to the National Spinal Cord Injury Association, 85% of SCI patients who survive the first 24 hours are still alive 10 years later.