- Published: 11 May 2016
- Written by Editor
StemCells, Inc. to Report 12-Month Cohort I Data from its Phase II Pathway Study
NEWARK, Calif., May 10, 2016 -- StemCells, Inc. (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. Further information about StemCells, Inc. is available at http://www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the future business operations of StemCells, Inc. (the "Company"), the prospect for continued clinical development of the Company's HuCNS-SC cells in CNS disorders, the timing of final data release in the Company’s Pathway Study in cervical spinal cord injury, and the belief that the improvements observed in the Pathway Study signify clinical evidence of a treatment effect improving both upper muscle strength and motor function following cellular transplant in spinal cord injury.. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including risks whether the FDA or other applicable regulatory agencies, including applicable institutional review boards at one or more clinical trial sites, will permit the Company to continue clinical testing or conduct future clinical trials; uncertainties regarding the timing of patient enrollment in the Company’s Pathway Study; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties regarding the Company’s plans to increase its authorized share capital and whether the Company’s Series B warrants will become exercisable; uncertainties regarding the validity and enforceability of the Company's patents; uncertainties as to whether the Company will become profitable; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.
Chief Financial Officer