MOUNTAIN VIEW, Calif.
, Feb. 14, 2014
/PRNewswire/ -- SanBio today announced the presentation of safety and efficacy data from its on-going Phase 1/2a clinical trial of SB623 cell therapy in patients with chronic stroke disability. The presentation was made by Dr. Gary Steinberg
, M.D., Ph.D., Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and the Neurosciences, Chairman, Department of Neurosurgery, Stanford University
School of Medicine, at a scientific session on Thursday at the International Stroke Conference in San Diego, CA.
Dr. Steinberg is the Principal Investigator for this study at Stanford
The data presented show that the clinical outcome results showing benefit on all three stroke scales (NIHSS, ESS and Fugl-Meyer) were highly significant at 6, 9 and 12 months post treatment. There have been no serious adverse events attributable to the cell therapy product.
This open-label clinical trial tests the safety and efficacy of a cell therapy product, SB623, in patients suffering from fixed motor deficits resulting from a subcortical ischemic stroke. The 18 patients range from 7 to 36 months post-stroke. SB623 was administered to the region adjacent to the damaged part of the brain.
"We are extremely pleased that this human clinical trial is going well. We look forward to taking it to the next phase trial for the many stroke patients in need," said Keita Mori, SanBio CEO.
"This study represents the first step in a novel therapeutic approach for the treatment of otherwise permanently impaired stroke patients. I am encouraged by the results thus far and am enthusiastic to initiate the next study," said Dr. Gary Steinberg, Principal Investigator.
A full description of the experimental results will be published later this year.
About SB623: SB623 is a proprietary allogeneic cell therapy product consisting of cells derived from bone marrow. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.
About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.
For more information: www.san-bio.com
SOURCE SanBio Inc.