SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients.
The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients suffering with chronic impairment following an ischemic stroke.
SanBio presented interim results from the study at the American Congress of Rehabilitation Medicine Conference last week, and claims that the study is the 1st of its kind in the U.S.
“When SB623 cells were administered in patients who had previously suffered a stroke, we saw statistically significant improvement compared to baseline in motor function, and this improvement appears to be sustainable,” SanBio’s head of clinical development Dr. Jerry Liu said in prepared remarks. “We are encouraged by this data. And hope to provide an effective treatment for the millions of people living with impairments following a stroke.”
The trial enrolled 18 patients with chronic motor deficits 6 months to 5 years following an ischemic stroke. Researchers gave patients injections of the genetically modified allogeneic mesenchymal stem cells, which were derived from the bone marrow of healthy adult donors.
The company reported 6 serious adverse events, such as subdural hematoma, seizure and pneumonia, but said that they were not likely related to the stem cell treatment.
“The data suggest that patients were able to tolerate SB623 cells at 12 months following procedure, and further demonstrates the potential for SB623 cells as a possible treatment option for patients with chronic impairments following a stroke,” Dr. Lawrence Wechsler from the University of Pittsburgh Medical Center explained.
