StemCells, Inc. to Report 12-Month Cohort I Data from its Phase II Pathway Study
OREANDA-NEWS. StemCells, Inc. (NASDAQ:STEM), a leading stem cell company developing novel cell-based therapeutics for the treatment of serious central nervous system diseases, today announced that it will be presenting top line 12-month data from Cohort I of its Pathway™ Study later this month as part of the Company’s first quarter 2016 analyst call. The Company is planning to then release detailed final data on Cohort I at a scientific venue in June.
The Pathway Study is a single blind, randomized, controlled clinical trial investigating the use of the Company’s proprietary HuCNS-SC® human neural stem cells for the treatment of chronic spinal cord injuries. The goal of the Pathway Study is to demonstrate improved upper body motor function and fine motor skills.
In April, we provided an update for the six patients enrolled in open label Cohort I from the Pathway Study. The six-month results from Cohort I showed an overall improvement of muscle strength and ability to perform functional tasks assessing dexterity and fine motor skills as assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessments.
The Company is currently enrolling at 13 sites in the United States and Canada and it has enrolled more than half of the total 40 patients planned for the second cohort in the study. The Company plans to complete enrollment in the Pathway Study this September and expects to have final 12-month results in the fourth quarter next year.
About StemCells, Inc.
StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC® platform technology (purified human neural stem cells) as a potential treatment for chronic spinal cord injury (SCI). The Company's Pathway Study, a Phase II proof-of-concept trial in chronic cervical SCI is actively enrolling at thirteen sites in the U.S. and Canada. Six-month interim data for the first cohort of the Pathway Study showed the first-ever clinical evidence of a treatment effect improving both upper muscle strength and motor function following cellular transplant in spinal cord injury. Top-line data from the Company's earlier Phase I/II clinical trial in chronic thoracic SCI showed measurable gains involving multiple sensory modalities and segments in seven of twelve patients enrolled in the study, including the conversion of two patients from the complete AIS-A spinal cord injury to the incomplete AIS-B spinal cord injury. The Company has also completed its Phase I/II clinical trial in geographic atrophy, the most advanced form of dry age related macular degeneration. Top-line results from this study show a positive safety profile and favorable preliminary efficacy data. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of progressive and durable donor-derived myelination by MRI. A Phase I study in children with Batten’s disease showed that transplantation of the cells into the brain was safe and resulted in long term survival of the cells.
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