Clinical Trial of SB623 Cell Therapy for Stroke Disability

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The Stanford University School of Medicine and SanBio Inc. today announced the initiation of a Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic cell therapy, SB623, on patients suffering from stable deficits resulting from previous stroke injuries.

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SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of stroke disability.

"SB623 represents a significant step forward in the development of regenerative therapies for the treatment of brain injury," said Keita Mori, SanBio CEO. "We are pleased to initiate a first-in-man study of SB623."

SB623 will be administered by intracranial injection into 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 will also be tested.

"This is an entirely new approach to therapy for stroke victims," said Dr. Gary Steinberg, the Lacroute-Hearst Professor, Chairman of the Department of Neurosurgery, and Director of the Stanford Institute for Neuro-Innovation and Translational Neurosciences at the Stanford University School of Medicine, and Principal Investigator of the study.

Sub-Investigator Dr. Neil Schwartz, Clinical Assistant Professor of Neurology, Stanford Stroke Center, said, "If successful, this cell therapy offers hope to otherwise permanently disabled patients."

What is SB623?

SB623 is a proprietary regenerative cell therapy consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is implanted directly adjacent to the area damaged by stroke and functions by producing proteins that aid the healing process.

References:

SanBio is a privately held San Francisco Bay Area biotechnology company, focused on the discovery and development of new regenerative cell therapy products.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics, and Lucile Packard Children's Hospital.

For details regarding this clinical trial, please refer to the Clinicaltials.gov website clinicaltrials.gov/ct2/show/NCT01287936

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