ここから本文です

見識ある皆さんのポスト、いつもながら興味深く拝見させていただき、とても感謝しています。 ;-D

さて、先週末にinfo.があったSB623のRMAT指定についてサーチエンジンで検索して見ますと、下記↓のように紹介されるてる記事が数多くヒットしますね。 Bloombergをはじめ、さらにはバイオ系の求人/求職webサイトなどでも取り上げられており、注目されつつあるように感じます。 こうやって米国における認知度&プレゼンスが上がることは、治療を待つ多くの患者さん達にとっても福音であると思います。 特に注目点はやはり「SanBio expects to initiate a Phase 3 trial for SB623 for the treatment of chronic neurological motor deficits secondary to TBI by the end of the fiscal year ending January 31, 2021.」の部分かと思います。 ;-)

=== 以下、甜菜 ===
SanBio Granted Regenerative Medicine Advanced Therapy Designation from the U.S. FDA for SB623 for the Treatment of Chronic Neurological Motor Deficits Secondary to Traumatic Brain Injury

Business Wire MOUNTAIN VIEW, Calif. -- September 19, 2019

The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation for SB623 cell therapy for the treatment of chronic neurological motor deficits secondary to traumatic brain injury (TBI). The designation is based on clinical results of SB623 including the Phase 2 Study of Modified Stem Cells in Traumatic Brain Injury (STEMTRA) trial.

Created under the 21st Century Cures Act, the RMAT designation is reserved for a regenerative medicine therapy intended to treat, modify, reverse, or cure a serious condition, and clinical evidence indicates that the therapy has the potential to address unmet medical needs for such disease or condition. Similar to the Breakthrough Therapy designation, the RMAT designation offers sponsors of cell and gene therapies eligibility for expedited development and regulatory review of their product candidate, including earlier and more frequent consultation with the FDA, and the potential for Priority Review and Accelerated Approval.

“The RMAT designation for SB623 is an important regulatory milestone for SanBio as we investigate it as a treatment option for patients with chronic neurological motor deficits resulting from a traumatic brain injury,” said Bijan Nejadnik, M.D., Chief Medical Officer and Head of Research. “TBIs are one of the most common health conditions worldwide that often cause long-term complications or death. We look forward to working with the FDA on a potentially accelerated clinical development program to address this serious unmet medical need.”

The RMAT designation augments the Sakigake Designation for innovative medical products from the Ministry of Health, Labour, and Welfare of Japan.

About SB623
SB623 is a proprietary, cell-based investigational product made from modified and cultured adult bone marrow-derived mesenchymal stem cells 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 expects to initiate a Phase 3 trial for SB623 for the treatment of chronic neurological motor deficits secondary to TBI by the end of the fiscal year ending January 31, 2021. SB623 is also currently in a Phase 2b clinical trial for treatment of chronic motor deficit resulting from ischemic stroke.

サンバイオを応援する掲示板 見識ある皆さんのポスト、いつもながら興味深く拝見させていただき、とても感謝しています。 ;-D  さ