SanBio announced the results of the Phase 2 STEMTRA trial of SB623 as a treatment for chronic motor deficit from traumatic brain injury was presented at the Military Health System Research Symposium 2019 Mountain View, Calif.
—August 30, 2019— The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.), a scientific leader in regenerative medicine for neurological disorders, today announced that the results of the US-Japan global Phase 2 trial (Study of Modified Stem Cells in Traumatic Brain Injury, or STEMTRA) of SB623 as a treatment for chronic motor deficit from traumatic brain injury (TBI) was presented at the Military Health System Research Symposium 2019 (hereafter the Symposium) held in Kissimmee, Florida, USA from August 19 to August 22, 2019, local time.
The Symposium, hosted by the US Department of Defense, is a major scientific meeting that provides a venue for presenting innovative research, focused specifically on the unique medical needs of the Department of Defense, namely medical therapies, drugs, and rehabilitative medicine for wounded warfighters. Recently, as one of the unique medical needs of the warfighters, traumatic brain injury has been gaining attention, and in light of such, SanBio was invited to present STEMTRA trial results at the Symposium.
SanBio completed enrollment of 61 patients for the STEMTRA trial in April 2018, and in November the same year, obtained favorable results indicating a statistically significant improvement in motor functions of the group administered SB623 compared with the control group, achieving the primary endpoint of the trial. Based on these results, regarding its TBI program in Japan, the Company plans to apply for manufacturing and marketing approval for SB623 as a regenerative medicine product during the fiscal year ending January 31, 2020 (February 2019–January 2020), using the nation’s conditional and term-limited authorization system for regenerative medicine products.
SanBio gave a presentation on the STEMTRA trial results at the annual scientific meeting of American Association of Neurological Surgeons held in San Diego, California, USA in April 2019. For further details of the presentation, please refer to the press release, “SanBio to announce the results of a Phase 2 STEMTRA trial regarding the use of SB623 as a treatment for TBI at AANS,” dated March 6, 2019.
>>9645
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SanBio announced the results of the Phase 2 STEMTRA trial of SB623 as a treatment for chronic motor deficit from traumatic brain injury was presented at the Military Health System Research Symposium 2019 Mountain View, Calif.
—August 30, 2019— The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.), a scientific leader in regenerative medicine for neurological disorders, today announced that the results of the US-Japan global Phase 2 trial (Study of Modified Stem Cells in Traumatic Brain Injury, or STEMTRA) of SB623 as a treatment for chronic motor deficit from traumatic brain injury (TBI) was presented at the Military Health System Research Symposium 2019 (hereafter the Symposium) held in Kissimmee, Florida, USA from August 19 to August 22, 2019, local time.
The Symposium, hosted by the US Department of Defense, is a major scientific meeting that provides a venue for presenting innovative research, focused specifically on the unique medical needs of the Department of Defense, namely medical therapies, drugs, and rehabilitative medicine for wounded warfighters. Recently, as one of the unique medical needs of the warfighters, traumatic brain injury has been gaining attention, and in light of such, SanBio was invited to present STEMTRA trial results at the Symposium.
SanBio completed enrollment of 61 patients for the STEMTRA trial in April 2018, and in November the same year, obtained favorable results indicating a statistically significant improvement in motor functions of the group administered SB623 compared with the control group, achieving the primary endpoint of the trial. Based on these results, regarding its TBI program in Japan, the Company plans to apply for manufacturing and marketing approval for SB623 as a regenerative medicine product during the fiscal year ending January 31, 2020 (February 2019–January 2020), using the nation’s conditional and term-limited authorization system for regenerative medicine products.
SanBio gave a presentation on the STEMTRA trial results at the annual scientific meeting of American Association of Neurological Surgeons held in San Diego, California, USA in April 2019. For further details of the presentation, please refer to the press release, “SanBio to announce the results of a Phase 2 STEMTRA trial regarding the use of SB623 as a treatment for TBI at AANS,” dated March 6, 2019.