NEWARK, Calif., May 14, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today provided a business update and reported financial results for the first quarter ended March 31, 2014.
"We have made substantial progress in our clinical programs this past quarter," said Martin McGlynn, president and CEO of StemCells, Inc. "We completed enrollment in both our Phase I/II chronic spinal cord injury trial and the first of two cohorts in our Phase I/II geographic atrophy of age-related macular degeneration trial (GA-AMD). We have also made substantial progress towards our goal of initiating controlled Phase II proof-of-concept studies in both indications in the second half of this year."
"To date, we have transplanted a total of thirty patients with HuCNS-SC®, our proprietary population of expandable, human neural stem cells and we plan to release a significant amount of new clinical data from all three of our ongoing clinical trials, involving the brain, spinal cord and the eye, thereby providing further insight into the potential of our technology, at scientific conferences in May and June."Recent Highlights:
- We transplanted the ninth subject in our Phase I/II clinical trial in chronic spinal cord injury, with our proprietary HuCNS-SC® product candidate in January 2014. This was the first subject to have undergone transplantation in North America expanding the trial from a single-site, single-country study to a multi-center, international program.
- In January 2014, StemCells, Inc. provided an update on the Company's ongoing development programs and translational work at the 2014 Alliance for Regenerative Medicine (ARM) State of the Industry Briefing. The Company discussed the planned initiation of controlled Phase II efficacy studies in spinal cord injury and geographic atrophy of age-related macular degeneration in 2014. The new trials are being designed as definitive proof-of-concept studies with hard clinical outcomes.
- StemCells, Inc.'s proprietary HuCNS-SC platform technology was featured in a television segment on CTV News Channel and the CTV National News in January 2014. The story, "Start of stem-cell study offers hope to patients with spinal cord injuries," includes an interview with the first subject treated in StemCells, Inc.'s North American Phase I/II clinical trial in spinal cord injury at the University of Calgary. The segment also includes interviews with Steve Casha, M.D., Ph.D., FRCSC, and Michael Fehlings M.D., Ph.D., FACS, FRCSC, the two Canadian principal investigators for the study.
- In an extended television segment which aired January 2014 on CTV News Channel, "A major advance in spinal treatment," Avis Favaro interviews Michael Fehlings M.D., Ph.D., FACS, FRCSC, Medical Director of the Krembil Neuroscience Centre, Professor of Neurosurgery at the University of Toronto, head of the Spinal Program at the Toronto Western Hospital, and principal investigator for the trial at the University of Toronto. Dr. Fehlings describes the trial as "a major advance in the field," and discusses the science behind StemCells, Inc.'s technology, the phase I/II clinical program and what this means for the field of spinal cord injury.
- StemCells, Inc. completed enrollment of the first of two planned patient cohorts in our clinical trial for GA-AMD in February 2014. This cohort consists of eight subjects, four of whom each received 200,000 cells and four of whom each received 1,000,000 cells of our proprietary HuCNS-SC product candidate. Interim results from this study will be shown at the Annual Meeting of the International Society for Stem Cell Research in Vancouver, Canada, June 18-21.
- In April 2014, the Company completed enrollment in our Phase I/II clinical trial in chronic spinal cord injury. The multi-national, open-label, Phase I/II trial is evaluating both safety and preliminary efficacy of our proprietary HuCNS-SC product candidate as a treatment for chronic spinal cord injury. The trial enrolled twelve subjects with chest-level injury to the spinal cord: seven patients with complete paralysis, no motor or sensory function below the point of injury, classified as complete (AIS A), according to the American Spinal Injury Association Impairment Scale, and five patients with no motor function and limited sensory function below the point of injury classified as incomplete (AIS B). Dr. Armin Curt, the principal investigator for the trial at Balgrist Hospital, Zurich will present a clinical update on this study on Saturday May 17, at the Annual Meeting of the American Spinal Injury Association, to be held in San Antonio, Texas.
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