The SanBio Group announced that the interim analysis from the Company's SB623 Phase 2 clinical "STEM cell therapy for TRAumatic brain injury" (STEMTRA) trial was published in the January 4, 2021 online issue of Neurology®, the medical journal of the American Academy of Neurology. The full manuscript, entitled "Cell Therapy for Chronic TBI: Interim Analysis of the Randomized Controlled STEMTRA Trial" can be accessed here. STEMTRA was a Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to traumatic brain injury (TBI). The study achieved its primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale (FMMS) score at six months for SB623-treated patients. Secondary efficacy endpoints improved from baseline but were not statistically significant versus control. In the six-month, pre-specified interim analysis, treatment with SB623 cells appeared to be safe and well-tolerated. In the trial, patients were followed for efficacy and safety for up to twelve months. STEMTRA was a 12-month, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to TBI (https://clinicaltrials.gov identifier: NCT02416492). In this study, SB623 cells were implanted directly around the site of brain injury. The primary endpoint was mean change from baseline in FMMS score at six months to measure changes in motor impairment. To be eligible for this trial, patients (ages 18-75) must have been at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). Patients must also have been able to undergo all planned neurological assessments and had no seizures in the prior three months. The STEMTRA trial treated 61 patients from 27 sites in the U.S., Japan and Ukraine. In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving an average 8.3-point improvement from baseline in the FMMS, versus 2.3-points in the control group, at 6 months (p=0.040). Of patients treated with SB623, 18 (39.1%) reached a 10 or more point improvement of FMMS compared to one control patient (6.7%; p=0.039). No new safety signals were identified, and the most commonly reported adverse event was headaches. SB623 is a proprietary, cell-based investigational product made from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) that undergo temporary genetic modification. Implantation of SB623 cells into injured nerve tissue in the brain is expected to trigger the brain's natural regenerative ability to recover lost motor functions. SanBio is preparing to file a Biologics License Application with the Pharmaceuticals and Medical Devices Agency in Japan for SB623 for the treatment of chronic motor deficits resulting from traumatic brain injury, while also making progress in its global development program. Further, the Company is working toward commencing clinical trials of SB623 for stroke in Japan. SB623 has been granted Sakigake designation for innovative medical products from the Ministry of Health, Labour, and Welfare of Japan, Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Association, and the Advanced Therapy Medicinal Product classification from the European Medicines Agency.