BioSenic performs further analysis of its phase 2 clinical trial data, leading to an optimal administration scheme for its next late-stage trial of arsenic trioxide in cGvHD New post-hoc analysis suggests a repeated administration cycle for BioSenic's upcoming phase 3 trial of oral arsenic trioxide (ATO) in chronic graft-versus-host disease (cGvHD) Mont-Saint-Guibert, Belgium, September 27, 2023, 7.00am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the completion of a post-hoc analysis of its phase 2 clinical trial of ATO, finding the best scheme for administration of an efficient treatment of cGvHD.

BioSenic对其2期临床试验数据进行了进一步分析，为cGvHD中三氧化二砷的下一个晚期试验提供了最佳给药方案。新的事后分析表明BioSenic即将进行的口服三氧化二砷3期试验的重复给药周期（ATO）在慢性移植物抗宿主病（cGvHD）比利时Mont-Saint-Guibert，2023年9月27日，上午7点00分CEST-BIOSENIC（Euronext Brussels and Paris:BIOS）是一家专门从事严重自身免疫性和炎症性疾病以及细胞治疗的临床阶段公司，今天宣布完成其ATO 2期临床试验的事后分析，寻找最佳方案用于有效治疗cGvHD。

The analysis will be used to decide on the best oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical trial. BioSenic phase 2 clinical trial entitled ‘Treatment of Chronic Graft Versus Host Disease with Arsenic Trioxide (GvHD-ATO)’ was conducted from 2016 to 2020 (ClinicalTrials.gov ID NCT02966301 - GMED16-001).

该分析将用于确定BioSenic即将进行的3期临床试验的最佳口服ATO的剂量。2016年至2020年进行了题为“用三氧化二砷（GvHD-ATO）治疗慢性移植物抗宿主病”的生物电子2期临床试验（ClinicalTrials.gov ID NCT02966301-GMED16-001）。

The first results were originally published in 2022 in the peer-reviewed journal Transplantation and Cellular Therapy under the title ‘High Response Rate and Corticosteroid (CS) Sparing with Arsenic Trioxide-Based First-Line Therapy in Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation’.

第一批结果最初发表于2022年，在同行评审的期刊“移植和细胞治疗”中，标题为“高反应率和皮质类固醇（CS），在异基因造血干细胞后慢性移植物抗宿主病中保留基于三氧化二砷的一线治疗移植“。

These collated results demonstrated that the first-line use of ATO and corticosteroids is associated with a high clinical response rate and rapid CS sparing in moderate to severe cGvHD following allo-HSCT (current standard treatment for several types of leukaemias). The primary endpoint of the phase 2 trial was preliminary efficacy based on the overall response rate (ORR; complete response [CR] or partial r.

这些整理的结果表明，ATO和皮质类固醇的一线使用与allo-HSCT（目前对几种类型的白血病的标准治疗）后中度至重度cGvHD的高临床反应率和快速CS保留相关。第二阶段试验的主要终点是基于总体缓解率（ORR；完全缓解[CR]或部分缓解率）的初步疗效。