Phase I Study with Dose-escalation and Expansion Evaluating the Safety and Efficacy of Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes Failing Erythropoiesis Stimulating Agents and Luspatercept (or Ineligible for the Latter)

Phase I study with dose-escalation and expansion evaluating the safety and efficacy of oral Arsenic (ATO) in low-risk Myelodysplastic Syndromes having failed to Erythropoiesis Stimulating Agents and Luspatercept (or ineligible for the latter).

开始日期2025-02-01

申办/合作机构

Groupe Francophone des Myélodysplasies

ChiCTR2400093196

/ Suspended临床4期IIT

Efficacy and safety of arsenic trioxide-based sequential chemotherapy in patients with relapsed/refractory ovarian cancer: a randomized controlled, open-label, multi-center clinical trial

开始日期2024-12-01

申办/合作机构

北京大学人民医院

NCT06088030

/ Recruiting临床2期IIT

Clinical Research on Efficacy and Safety of Arsenic Trioxide Combined With Chemotherapy in p53-mutated Pediatric Cancer Patients：A Prospective，Single-arm, Multi-center Study

This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.

开始日期2023-12-13

申办/合作机构

中山大学孙逸仙纪念医院

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100 项与三氧化二砷相关的临床结果

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100 项与三氧化二砷相关的转化医学

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100 项与三氧化二砷相关的专利（医药）

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6,112

项与三氧化二砷相关的文献（医药）

2025-01-09·BLOOD

Acute promyelocytic leukemia: long-term outcomes from the HARMONY project

Article

作者: Gurnari, Carmelo ; Guarnera, Luca ; Platzbecker, Uwe ; Fazi, Paola ; Russell, Nigel ; Dillon, Richard ; Ossenkoppele, Gert ; Lehmann, Söhren ; La Sala, Edoardo ; Piciocchi, Alfonso ; Döhner, Konstanze ; Vignetti, Marco ; Voso, Maria Teresa ; Döhner, Hartmut ; Hernández-Rivas, Jesús María ; Bullinger, Lars ; Giménez, Laura Tur ; Thomas, Ian ; Ramiro, Angela Villaverde ; Haferlach, Torsten

Abstract:

Treatment outcomes for acute promyelocytic leukemia (APL) have improved with the widespread use of targeted therapy with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). Our study aimed to validate these data in a large patient cohort, and to redefine prognostic factors. Leveraging the HARMONY Platform, we analyzed 1438 newly diagnosed patients with APL, diagnosed between 1999 and 2022. Patient data derived from the 2 international multicenter Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA)-APL0406 and National Cancer Research Institute (NCRI)-AML17 trials and 4 European registries: the Haemato Oncology Foundation for Adults in the Netherlands, Belgium and Luxembourg (HOVON), AML Study Group (AMLSG), Swedish AML Registry, and Study Alliance Leukemia (SAL). The study cohort included 721 males and 717 females, with a median age of 50.5 years (range, 16-94 years). Of 1309 patients starting therapy, 562 received ATRA-ATO, and 747 idarubicin-based chemotherapy (AIDA-like CHT). Early death (ED) occurred in 85 of 1438 patients (5.9%) at a median of 9 days after APL diagnosis and was independently associated with increasing age and high Sanz risk score (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.04-1.08; and OR, 4.65; 95% CI, 2.55-8.51, respectively). The median follow-up was 5.5 years (interquartile range, 3.2-7.5 years). ATRA-ATO regimen was associated with the best outcome, reaching 91% 7-year overall survival (vs 81% for AIDA-like CHT; hazard ratio [HR], 2.14; 95% CI, 1.51-3.05), 89% event-free survival (vs 71% for AIDA-like CHT; HR, 2.72; 95% CI, 2.01–3.69), and 3% relapse (vs 13% for AIDA-like CHT; HR, 4.19; 95% CI, 2.38-7.39; P < .001 for all outcomes). The survival advantage of ATRA/ATO was independent of patients’ age, Sanz risk score, and treatment scenario. Our study confirms the superiority of ATRA-ATO over ATRA-chemotherapy in patients with APL. Reducing the risk of ED still represents an unmet medical need, in particular in older patients and in high-risk APL.

2025-01-02·IMMUNOPHARMACOLOGY AND IMMUNOTOXICOLOGY

Combined bisoprolol and trimetazidine ameliorate arsenic trioxide -induced acute myocardial injury in rats: targeting PI3K/GSK-3β/Nrf2/HO-1 and NF-κB/iNOS signaling pathways, inflammatory mediators and apoptosis

Article

作者: El-Shoura, Ehab A. M. ; Abdel-Wahab, Basel A. ; Kozman, Magy R. ; Ahmed, Yasmin M. ; Abdel-Sattar, Asmaa Ramadan

BACKGROUND:

Arsenic-trioxide (ATO) is an effective therapy for acute promyelocytic leukemia. Unfortunately, its utility is hindered by the risk of myocardial injury. Both bisoprolol (BIS) and trimetazidine (TMZ) have various pharmacological features, including anti-oxidant, anti-inflammatory, and anti-apoptotic properties.

AIM:

The cardioprotective effects of BIS and TMZ were studied, and their mechanistic role in ameliorating ATO-induced myocardial injury.

MATERIALS AND METHODS:

Forty male Wistar rats were randomly allotted into five groups as follows: normal control group (received normal saline, orally), ATO group (7.5 mg/kg, orally), BIS (8 mg/kg, orally), TMZ (60 mg/kg, orally), and finally combination group (BIS+TMZ+ATO). Following 21 days, samples of serum and cardiac tissues were obtained to perform biochemical, molecular, and histopathological investigations.

RESULTS:

The present study showed that ATO caused myocardial injury evidenced by changes in serum biomarkers (Aspatate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, creatine kinase-MB, and cardiac troponin-1), electrolyte imbalance, and lipid profiles alongside histopathologic changes. In addition, ATO administration significantly elevated malondialdehyde, nicotinamide adenine dinucleotide phosphate hydrogen oxidase, myloperoxidase, total nitrite, inducible nitric oxide synthase, tumor necrosis factor-alpha, interleukin-1β, interleukin-6, 8-Hydroxy-2'-deoxyguanosine, nuclear factor NF-kappa-B p65 subunit, glycogen synthase kinase-3 beta, and caspase-3 expression contemporaneously with down-regulation of reduced glutathione, glutathione peroxidase, superoxide dismutase, catalase, heme oxygenase 1, nuclear factor erythroid 2-related factor 2, phosphatidylinositol-3 kinase, p-PI3K, and Bcl-2 expression. Interestingly, pretreatment with BIS and TMZ significantly reversed the detrimental effects of ATO-induced myocardial injury at both cellular and molecular levels. Otherwise, combining the two drugs displayed more enhancement than each drug alone.

CONCLUSION:

The present research depicted that BIS and TMZ have the potential to protect the heart and provide therapeutic benefits by preventing acute heart injury induced by ATO. This is achieved by reversing the redox-sensitive pathway, reducing inflammation, and inhibiting apoptosis.

2025-01-01·PHARMACOLOGICAL RESEARCH

Unveiling the link between NADPH oxidase 2 activation and mitochondrial superoxide formation in leukemic cell killing induced by arsenic trioxide

Article

作者: Fiorani, Mara ; Guidarelli, Andrea ; Cantoni, Orazio ; Spina, Andrea ; Buffi, Gloria

This study focused on the interplay between NADPH oxidase 2 (NOX 2) activation and mitochondrial superoxide (mitoO₂^.-) formation induced by clinically relevant concentrations of arsenic trioxide (ATO; As₂O₃) in acute promyelocytic leukemia (APL) cells. Carefully controlled inhibitor studies and small interfering RNA mediated downregulation of p47^phox (a component of the NOX 2 complex) expression demonstrated that, in an APL cell line, ATO promotes upstream NOX 2 activation critically connected with the formation of mitoO₂^.- and with the ensuing mitochondrial permeability transition (MPT)-dependent apoptosis. Instead, acute myeloid leukemia (AML) cell lines respond to ATO with low NOX 2 activation, resulting in a state that is non-permissive for mitoO₂^.- formation. Consistently, through rescue experiments, we demonstrate that pharmacological stimulation of NOX 2 overcomes resistance in these cells, thereby initiating the same cascade of downstream events observed in APL cells. As a final note, several lines of evidence, including measurement of glutathione, catalase and glutathione peroxidase levels, indicated that the antioxidant machinery was similar in APL and AML cells. The results regarding nuclear factor erythroid 2 p45-related factor 2-dependent antioxidant responses were instead of more complex interpretation as NB4 cells appeared particularly responsive to ATO. Our findings allow a novel interpretation of the interplay between NOX 2 activation and mitoO₂^.- formation induced by ATO, ultimately steering leukemic cells towards MPT-dependent apoptosis. These mechanistic insights provide a rationale for the disparate responses of APL and AML cells to ATO, offering potential avenues for the development of therapeutic intervention tailored to specific leukemia subtypes.

196

项与三氧化二砷相关的新闻（医药）

2025-01-07

·GlobeNewswire-Health Care

Bionano Announces Publication Showing that OGM Identifies Variant that Indicates Use of Proven Therapy in Acute Promyelocytic Leukemia

A case study published by researchers at Johns Hopkins University showed that optical genome mapping (OGM) detected a structural variant that was missed by karyotyping and non-informative by FISH, which they classified as a PML::RARA fusion known to occur in acute promyelocytic leukemia (APL)The researchers reported that APL, an aggressive subtype of acute myelogenous leukemia (AML), responds well to treatment with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) classes of targeted therapies but that in about 13% of cases of APL, conventional cytogenetics fails to identify the variant(s) that indicate(s) these treatmentIdentification of this PML::RARA fusion variant by OGM is consistent with previously reported findings which show that OGM can detect variants found by standard cytogenetics and can also find additional variants that are missed by these techniques SAN DIEGO, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a publication from the Johns Hopkins University School of Medicine in Genes showing that optical genome mapping (OGM) identifies a variant in an aggressive form of acute myelogenous leukemia (AML) known as acute promyelocytic leukemia, or APL. This variant is often missed by conventional cytogenetic techniques. In the case study, researchers reported that OGM detected a structural variant that was missed by karyotyping and non-informative by FISH, which they classified as a PML::RARA fusion known to occur in APL. According to the publication, APL is a subtype of AML that responds well to treatment with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) classes of targeted therapies but that in about 13% of cases of APL, conventional cytogenetics either fails or is unable to clearly identify the variant(s) that indicate(s) these treatment(s). Notably, identification of this PML::RARA fusion variant by OGM is consistent with previously reported findings which show OGM can detect variants found by standard cytogenetics but can also find likely pathogenic variants that are missed or deemed uninterpretable by these techniques. Erik Holmlin, president and chief executive officer of Bionano, commented, “This case study supports the view that the standard of care techniques used for devastating diseases like blood cancer are insufficient to reliably guide therapy selection and patient management, due to their tendency to miss actionable variants for a significant fraction of cases. It also shows that OGM, with its higher resolution, streamlined workflow and ability to find more variants, can be a suitable alternative to these techniques, and could result in better therapy selection and patient management decisions.” The full research publication is available at: Optical Genome Mapping Reveals Complex and Cryptic Rearrangement Involving PML::RARA Fusion in Acute Promyelocytic Leukemia. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com or www.bionanolaboratories.com. Bionano’s products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano Genomics This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “ability,” “can,” “could,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, OGM’s ability to detect variants undetected by traditional cytogenetic techniques; OGM’s ability to detect the PML::RARA fusion in acute promyelocytic leukemia (APL); the potential utility that variants detected by OGM may have in therapy selection or patient management decisions; the utility of OGM for uses described in the publication referenced in this press release; the utility and ability of OGM to detect variants missed by traditional cytogenetic techniques; and other statements that are not historical facts. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: global and macroeconomic events, such as recent and potential bank failures, supply chain disruptions, global pandemics, inflation, and the ongoing conflicts between Ukraine and Russian and Israel and Hamas, on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; the failure of OGM to detect variants undetected by traditional cytogenetic techniques; the failure of OGM to detect the PML::RARA fusion in acute promyelocytic leukemia (APL); the failure of OGM to prove useful in therapy selection or patient management decisions; the failure of OGM to be useful for the applications described in the publication referenced in this press release; the failure of OGM to detect variants missed by traditional cytogenetic techniques; future publications that contradict the findings of the publication referenced in this press release; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

临床结果临床研究

2024-12-30

·梅斯医学

震惊！医生不能再擅自使用西地兰了？未告知患者医疗风险，多名医生被立案处罚！医生困惑：抢救时也要问患者？西地兰难道不是成品药？

医生不能再擅自使用西地兰了？未告知患者医疗风险，多名医生被立案处罚！ 12月12日，永州市公布了第二批2024年非法行医行政处罚典型案例，其中易医生、欧医生、刘医生等多名医生的处罚案件引起讨论，一时之间令很多医生不知所措，十分茫然。仔细查看这几名医生的案由，可以发现一个共同点。根据官方通报，卫生健康委卫生监督员在某县某医院检查发现，该院三名医生在为患者使用毒性药品去乙酰毛花苷（俗称西地兰）时，未向患者告知医疗风险、替代方案及未取得患者书面同意。通报表示，有一定危险性，可能产生不良后果的检查和治疗为“特殊治疗”，在以上案件中为患者使用西地兰被认定为特殊治疗（使用毒性药品），三名涉事医生违反了《医疗纠纷预防和处理条例》第十三条第一款的规定，依据《医疗纠纷预防和处理条例》第四十七条第(二)项的规定，结合《湖南省卫生健康行政处罚裁量权基准》，卫生行政部门给予该医院警告、罚款人民币壹万伍仟元整（15000.00元）的行政处罚，同时责令立即改正上述违法行为。对于以上3名医师的违法违规行为依据《中华人民共和国医师法》的有关规定对其进行另案查处。典型案例一经发出，立刻引起了医生同行们的讨论。 12月24日，陕西一名重症医学科的医生表示：“西地兰是我们常用的药物，我也曾用过西地兰抢救心衰病人，似乎都没有单独签过字。现在，你告诉我使用西地兰不签字会受到行政处罚，我以后不敢用了。西地兰这个药，都是危急情况用来抢救的，有时候需要用就赶紧用了，难道用的时候还要去找患者单独征得同意并签字吗？” 浙江一名麻醉科医生也认为：“这个药的使用，我们科室没有单独签过字，照这样说，以后使用西地兰、阿托品，是不是用一个药就要单独签一个知情同意书呢？用之前给家属照着说明书读一下这个药物的危害，强调这个药物的毒性，家属不让用，那就不用了是不是？心衰时强心最常用西地兰，如果抢救时需要详细告知药物说明、需要和家属拉扯并签写知情同意书，那耽误了时间，患者都不一定能救得过来。抢救时可能会用到多种药物，私以为，是药三分毒，哪一个药没有副作用呢，何况在这种抢救的情况下，等告知完风险后，病人都没了，还用什么药。”西地兰到底是不是毒性药品？可以肯定的是，西地兰不是原料药！众所周知，西地兰是一种快速强心药，用药后强心作用的时间比较快，在体内的代谢及排泄也快，蓄积性小，作用持续时间也短。西地兰通常采用静脉注射，适用于危重的急症患者，在短时期内可以反复、多次使用。它可快速减轻急性心衰患者的症状，是目前唯一可以减慢心率的正性肌力药物，可以快速减低房颤患者的心室率，可较好地维持心衰患者稳态。西地兰常用，有效，被视为毒性药品又是怎么一回事呢？让我们一点一点梳理有关这方面的规定，来一个清晰的认识。 1988年，中华人民共和国国务院令（国务院令第23号）正式发布《医疗用毒性药品管理办法》，其中给出了定义，医疗用毒性药品系指毒性剧烈、治疗剂量与中毒剂量相近，使用不当会致人中毒或死亡的药品。医疗用毒性药品管理品种目录具体包括：一、毒性中药品种（28种）：砒石（红、白）、砒霜、水银、生马钱子、生川乌、生草乌、生白附子、生附子、生半夏、生南星、生巴豆、斑蝥、青娘虫、红娘子、生甘遂、生狼毒、生藤黄、生千金子、生天仙子、闹羊花、雪上一枝蒿、红升丹、白降丹、蟾酥、洋金花、红粉、轻粉、雄黄。二、毒性西药品种（11种）：去乙酰毛花甙丙(去乙酰毛花苷C)、阿托品、洋地黄毒甙、氢溴酸后马托品、三氧化二砷、毛果芸香碱、升汞、水杨酸毒扁豆碱、亚砷酸钾、氢溴酸东莨菪碱、士的年。毒性药品的包装容器上必须印有毒药标志，即黑底白字的一个“毒”字，在运输毒性药品的过程中，应当采取有效措施，防止发生事故。因此，想判断一种药品是否属于毒性药品，最直观的方法就是看一看包装盒和包装瓶。到了1990年，卫生部药政局关于《医疗用毒性药品管理办法》又做了补充规定（卫药政发[90]第92号），其中表示：《医疗用毒性药品管理办法》中所列的毒性药品，西药品种是指原料药，中药品种系指原药材和饮片。不含制剂(单方制剂地方有规定的按地方规定办理)。根据定义，原料药是指尚未经过加工的药品原始形态，因此它不包含任何辅料；成品药是经过一系列严格的制备工艺加工而成的药品，它是由原料药加上适当的辅料进行加工制成的。此后，在2008年，国家又发布将A型肉毒毒素列入毒性药品管理的通知（国食药监办[2008]405号）。把1988年的《医疗用毒性药品管理办法》和1990年的《医疗用毒性药品管理办法》补充规定综合在一起，我们就有了一个非常重要的发现：西地兰（去乙酰毛花甙注射液）是一种成熟的药品，它似乎不属于原料药，它是成品药！查阅已上市的西地兰说明书可知，西地兰的辅料包括乙醇、甘油和注射用水，这些辅料用于稀释和配制药物，以确保药物的稳定性和使用的安全性。这就突然明白了，对于西药品种，如果是毒性药品，它必须是原料药，西地兰是经过一系列工艺严格制成的成品药，它是有辅料的。同意药物抢救不就是授权医生可以用药吗？难道用一个药就得签一个知情同意书？不再讨论西地兰是否属于毒性药品了，既然有同行因为给患者使用西地兰未签知情同意书，受到了处罚，那就应该引起我们的警惕：是不是以后使用一个药，就要签一个知情同意书？对此，河南一名急诊医生表示：“如果我们反复向患者交代这些药物的副作用，患者未必能明白这些专业知识。再说，本来患者放心让你治疗，你却刻意向患者交代用药的危害，反复征求同意，这反而让患者产生恐惧，若得不到患者同意，我们就不为患者治疗了吗？作为一个成熟的医生，我难道连用药自主权也没有了吗？” 常州一名心内医生认为：“如果以后专门打一堆知情同意书，用一个药签一个字，那我感觉也没治疗的必要了。我想说的是，病重告知书里患者签了同意药物抢救，难道这不是授权医生可以自行选择使用药物吗？这又从哪来了一个西地兰的知情同意书？这不是多此一举吗？” 关于在治疗中取得患者的知情同意书，永州市通报强调：根据《医疗纠纷预防与处理条例》第十三条，医务人员在诊疗活动中应当向患者说明病情和医疗措施。需要实施手术，或者开展临床试验等存在一定危险性、可能产生不良后果的特殊检查、特殊治疗的，医务人员应当及时向患者说明医疗风险、替代医疗方案等情况，并取得其书面同意；在患者处于昏迷等无法自主作出决定的状态或者病情不宜向患者说明等情形下，应当向患者的近亲属说明，并取得其书面同意；紧急情况下不能取得患者或者其近亲属意见的，经医疗机构负责人或者授权的负责人批准，可以立即实施相应的医疗措施。现在，既然西地兰被认定为“特殊治疗”药物（毒性药品），那各位同行们以后就不要懒惰了，在给患者使用时务必要取得患者的知情同意书，医生有义务详细告知患者药物的作用、潜在风险和副作用，以确保患者知情同意。反正要签的各种知情同意书很多很多，也不差这一个，当有了处罚的先例之后，还是谨慎为好，这既是保护患者也是保护自己。撰文 | 阿拉斯加宝编辑 | 阿拉斯加宝 ● 震撼！想找的医生在休班，竟投诉医生要求回来看病！急诊医生上厕所也被投诉！主任医生：以后让机器人来当医生吧！医护委屈奖很有必要！ ● 一杯茶，竟喝下上亿颗微塑料！真实泡茶场景模拟研究揭秘：微塑料已“渗透”到茶包！且能被人类肠道吸收！你还在泡茶包吗？ ● 震撼！48岁主治却领导2个副主任医师！能力强技术好，科室重用，职称却很低！职级倒挂现象频出，主治医生也能当科主任！要学习协和经验版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

医药出海

2024-12-13

·biosenic.com

Medsenic, a subsidiary of BioSenic, has signed a conditional letter of intent that could secure funding to cover part of the costs for its clinical trial on chronic graft-versus-host disease

Mont-Saint-Guibert, Belgium, 13 December 2024, 17:30 CET – BIOSENIC (Euronext Brussels and Paris : BIOS) announces the signing of a conditional letter of intent between Medsenic SAS and the Singapore based TrialCap Pte. Ltd. as a first step for a proposed financing arrangement through both debt and equity subscription. Final agreements are yet to be concluded between the two companies – which cannot be guaranteed at this stage – and, if finalized, the financing will among others remain contingent on the creation of an Australian subsidiary by Medsenic and the acquisition of additional resources necessary for carrying out the clinical trial. Medsenic is hence actively seeking the additional funding required to execute its program and initiate research, which is supported by the positive Phase 2 results and promising preclinical trials of its experimental drug in an oral formulation of its active ingredient, arsenic trioxide (ATO). BioSenic SA Rue Granbonpré 11 – Bâtiment H (bte 24) 1435 Mont-St-Guibert – Belgium T.: +32 493 09 73 66 info@biosenic.com Contact Receive information about BioSenic

临床2期

100 项与三氧化二砷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02106	三氧化二砷	L01XX27	DB01169

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性早幼粒细胞白血病	美国	Cephalon, Inc.	2000-09-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床3期	美国	Cephalon, Inc.	2007-10-01
急性髓性白血病	临床3期	加拿大	Cephalon, Inc.	2007-10-01
系统性红斑狼疮	临床2期	法国	Medsenic SAS	2013-07-01
小细胞癌	临床2期	美国	Teva Pharmaceuticals USA, Inc.	2011-08-01
小细胞癌	临床2期	美国	Cephalon, Inc.	2011-08-01
小细胞肺癌	临床2期	美国	Cephalon, Inc.	2011-08-01
小细胞肺癌	临床2期	美国	Teva Pharmaceuticals USA, Inc.	2011-08-01
转移性子宫内膜恶性肿瘤	临床2期	美国	Cephalon, Inc.	2010-03-01
胶质瘤	临床2期	美国	Cephalon, Inc.	2005-05-01
胶质瘤	临床2期	美国	CTI BioPharma Corp.	2005-05-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2024	N/A	急性早幼粒细胞白血病	-	Standard-dose ATO (10mg IV daily for 28 days)	膚鏇壓衊製鹹網憲鑰壓(製遞網選鹹窪蓋蓋憲鏇) = Patients receiving ATO treatment have a high rate of adverse events in both groups, reducing the total ATO dosage at induction treatment may reduce the adverse event rate and help patients achieve the same long-term survival. 鑰網鏇簾襯艱醖簾醖衊 (餘獵鏇遞選範築襯壓膚 )	-	2024-12-09
				Low-dose ATO (10mg IV daily for less than 28 days)
NCT01409161 (Pubmed \| Cancer)	临床2期	急性早幼粒细胞白血病	-	ATO-ATRA + Gemtuzumab ozogamicin	遞願憲觸憲網製齋鬱構(積蓋鏇製鑰願壓構鹹繭) = 齋選齋簾願窪願鏇鑰夢簾願構醖夢積選選衊淵 (鑰鏇廠範蓋願觸艱獵夢, 88.9% ~ 97.7) 更多	积极	2024-11-25
EHA2024	N/A	急性早幼粒细胞白血病一线	-	ATO-based chemotherapy-free regimens	壓襯鑰糧範壓製衊餘繭(製窪糧窪衊餘蓋鑰夢憲) = 糧糧醖遞網製鹹鹹範齋獵憲窪顧遞選鏇鏇繭醖 (膚窪觸艱廠淵鹹築壓壓, 0.06‒0.47)	不佳	2024-05-14
				ATO-containing chemotherapy-based regimens	壓襯鑰糧範壓製衊餘繭(製窪糧窪衊餘蓋鑰夢憲) = 鏇鹽築繭壓淵積鬱網壓獵憲窪顧遞選鏇鏇繭醖 (膚窪觸艱廠淵鹹築壓壓, 0.70‒1.43)
EHA2024	N/A	急性早幼粒细胞白血病	-	ATRA-ATO	遞糧製獵醖衊窪糧遞築(獵獵廠淵鹹糧膚繭願餘) = 33% of pts with leukocytosis developed bone pain poorly responsive to analgesics during leukocyte increase; this phenomenon was not observed in any of pts without leukocytosis (p=0.002) 積膚網窪壓襯膚製構廠 (顧鏇淵獵構構願醖醖鏇 ) 更多	-	2024-05-14
				Hydroxyurea
EHA2024	N/A	急性早幼粒细胞白血病	-	Arsenic Trioxide (ATO)	夢淵餘繭醖鬱廠夢遞憲(蓋遞齋積築憲獵願選襯) = 醖衊壓築鹽製醖鑰窪簾蓋憲鏇築艱餘蓋選齋簾 (構壓廠遞積鬱齋築遞衊 ) 更多	-	2024-05-14
				Chemotherapy	蓋壓繭壓築襯構觸構獵(蓋鏇觸顧遞餘糧製蓋鹹) = 蓋範製顧鏇網膚淵衊蓋觸窪獵遞顧憲範夢淵顧 (構淵蓋繭構遞製遞獵鹹 )
ASH2023	N/A	急性早幼粒细胞白血病	135	ATRA-ATO	餘餘築壓簾廠築築夢鹽(願製齋廠齋遞獵觸糧網) = 齋鹽膚選範餘廠範製餘醖簾糧鑰憲積壓遞窪膚 (膚築襯餘鏇獵鹹選襯齋 ) 更多	积极	2023-12-09
				ATRA+chemotherapy	餘餘築壓簾廠築築夢鹽(願製齋廠齋遞獵觸糧網) = 選鏇築糧襯廠壓齋壓憲醖簾糧鑰憲積壓遞窪膚 (膚築襯餘鏇獵鹹選襯齋 ) 更多
ASH2023	N/A	急性早幼粒细胞白血病	-	Oral-Arsenic Trioxide	壓艱蓋製夢範醖衊廠顧(網糧鹹獵壓網選醖壓餘) = 鏇繭廠簾窪壓遞艱醖獵壓壓夢夢膚簾艱襯鬱鏇 (艱積鹽夢簾構壓鏇網憲 ) 更多	-	2023-12-09
				All-Trans Retinoic Acid	壓艱蓋製夢範醖衊廠顧(網糧鹹獵壓網選醖壓餘) = 鬱艱繭積憲選窪壓獵鬱壓壓夢夢膚簾艱襯鬱鏇 (艱積鹽夢簾構壓鏇網憲 ) 更多
NCT00045565 (ASCO2023)	临床1期	胶质母细胞瘤	30	Arsenic Trioxide once weekly	繭鹹遞淵製簾衊觸範鑰(顧衊鏇製鹽簾淵艱觸廠) = Major dose limiting toxicities were increased aspartate and alanine aminotransferases and one case of hyperkalemia 觸齋壓淵簾壓淵鬱膚醖 (夢繭鬱鹽膚鏇顧淵範壓 )	-	2023-05-31
				Arsenic Trioxide twice weekly
NCT02966301 (Pubmed) 人工标引	临床2期	慢性移植物抗宿主病一线	21	Corticosteroids+Arsenic Trioxide	糧窪積築簾糧範遞顧餘(願鹹築餘觸餘艱鹹獵夢) = 獵糧艱淵顧夢襯糧糧鬱獵鹽衊廠顧鑰網糧製鹽 (範鹹憲繭壓齋構積鑰繭, 50.9 ~ 91.3) 更多	积极	2022-07-10
NCT02966301 (GvHD-ATO, CTgov)	临床2期	慢性移植物抗宿主病	21	Arsenic Trioxide Injectable Solution	餘餘膚鑰願餘構壓範觸(遞範淵鏇鑰膚膚築餘觸) = 衊膚鹹淵鏇選夢憲願觸觸選鹽醖艱獵壓簾鏇襯 (積構襯範蓋糧觸範夢襯, 膚構壓願鹽鹹製築遞憲 ~ 壓壓顧鬱築顧餘網憲醖) 更多	-	2022-05-09