MOUNTAIN VIEW, Calif., Sept. 4, 2013 /PRNewswire/ -- SanBio Inc. today announced the successful completion of enrollment of patients in its Phase 1/2 clinical trial testing the safety and efficacy of a novel allogeneic cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. A total of 18 patients have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been attributed to the cell therapy product. For details regarding this clinical trial, please refer to www.clinicaltrials.gov/ct2/show/NCT01287936.
SB623 is derived from bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "Complete enrollment of this clinical trial is a major step in the development of SB623 for stroke patients. Planning for the next phase of testing is already underway." said Keita Mori, SanBio CEO.
SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.
"Stroke is the major cause of disability in the United States. Regenerative medicine offers hope to those with otherwise permanent functional limitations. This trial represents an important advance in bringing restorative therapeutics for neurologic disorders into the clinical arena. Three measures of efficacy (NIHSS, ESS, Fugl-Meyer) all show a trend toward improvement. We are looking forward to the next clinical trial," said Dr. Gary K. Steinberg, M.D., Ph.D., Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and the Neurosciences, Director, Stanford Institute for Neuro-Innovation and Translational Neurosciences, Chairman, Department of Neurosurgery, Stanford University School of Medicine.
Dr. Steinberg will be presenting preliminary results from this clinical trial at the International Stroke Conference February 12-14 in San Diego, California.
"Completion of this study is an important milestone in development of cell therapy treatment for chronic stroke. The demonstration of safety and feasibility is encouraging and we look forward to further trials using these cells," said Dr. Lawrence R. Wechsler, M.D., Henry B. Higman Professor and Chair, Department of Neurology, University of Pittsburgh Medical School
"The SanBio trial was completed smoothly and will help to guide important research into stroke repair and regenerative medicine strategies. It is hoped that the next study can begin soon and advance patient care," said Dr. Douglas Kondziolka, MD, MSc ,FRCSC, FACS,Professor of Neurosurgery, Vice-Chair, Clinical Research (Neurosurgery), Professor of Radiation Oncology, Director, Center for Advanced Radiosurgery, NYU Langone Medical Center.
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.