In a webcast this afternoon, StemCells (NASDAQ:STEM) presented six-month interim results from the first cohort in its Phase 2 proof-of-concept Pathway Study evaluating its HuCNS-SC platform (purified human neural stem cells) in cervical spinal cord injury, an open-label dose escalation arm used to determine the cell dose for the second cohort of the trial. Final results from this cohort are expected in Q2 2016.
Dose escalation from 15M to 30M to 40M cells. Dose of 40M cells was well tolerated and will be the dose for the second cohort. Safety profile is acceptable. Five of six patients in the first cohort showed improved upper extremity muscle strength and four showed improved function in dexterity.
The second cohort, expected to be 40 participants with complete loss of motor function below the point of injury, will be a randomized, single-blind study statistically powered to show efficacy. Final results from the study are expected in 2017.
Shares are up 19% after hours on robust volume.
Subscribe for full text news in your inbox