Evaluation of the efficacy and safety of MeiLianFuXin Liquid in the treatment of radiation-induced oral mucositis in patients with head and neck malignant tumors: A multicenter, randomized, double-blind, placebo-controlled, dose-exploration phase II clinical trial.

开始日期2024-05-20

申办/合作机构-

100 项与放射性口腔黏膜炎相关的临床结果

登录后查看更多信息

100 项与放射性口腔黏膜炎相关的转化医学

登录后查看更多信息

0 项与放射性口腔黏膜炎相关的专利（医药）

登录后查看更多信息

649

项与放射性口腔黏膜炎相关的文献（医药）

2024-10-01·Strahlentherapie und Onkologie

Impact of dose volume parameters and clinical characteristics on radiation-induced acute oral mucositis for head and neck cancer patients treated with carbon-ion radiotherapy dose volume outcome analysis

Article

作者: Guan, Xiyin ; Hu, Chaosu ; Li, Yujiao

OBJECTIVESTo assess the predictive value of different dosimetric parameters for acute radiation oral mucositis (ROM) in head and neck cancer (HNCs) patients treated with carbon-ion radiotherapy (CIRT).METHODS44 patients with HNCs treated with CIRT were evaluated for acute ROM which was defined as severe when the score ≥3 (acute ROM was scored prospectively using the Radiation Therapy Oncology Group (RTOG) score system). Predictive dosimetric factors were identified by using univariate and multivariate analysis.RESULTSMale gender, weight loss >5%, and total dose/fractions were related factors to severe ROM. In multivariate analysis, grade ≥3 ROM was significantly related to the Dmax, D10, D15, and D20 (P < 0.05, respectively). As the receiver operating characteristics (ROC) curve shows, the area under the curve (AUC) for D10 was 0.77 (p = 0.003), and the cutoff value was 51.06 Gy (RBE); The AUC for D15 was 0.75 (p = 0.006), and the cutoff value was 42.82 Gy (RBE); The AUC for D20 was 0.74 (p = 0.009), and the cutoff value was 30.45 Gy (RBE); The AUC for Dmax was 0.81 (p < 0.001), and the cutoff value was 69.33 Gy (RBE).CONCLUSIONMale gender, weight loss, and total dose/fractions were significantly association with ROM. Dmax, D10, D15 and D20 were identified as the most valuable predictor and we suggest a Dmax limit of 69.33 Gy (RBE), D10 limit of 51.06 Gy (RBE), D15 limit of 42.82 Gy (RBE), and D20 limit of 30.45 Gy (RBE) and for oral mucosa.

2024-10-01·Future Oncology

Risk factor and prediction model development for severe radiation-induced oral mucositis in head and neck tumors

Article

作者: Yang, Shujuan ; Wang, Jiajia ; Gu, Liqiong ; Zhi, Caixia

Aim: This article aims to identify risk factors for severe radiation-induced oral mucositis (RIOM) in head and neck cancer (HNC) patients. In addition, we intend to establish a predictive model in patients undergoing intensity-modulated radiotherapy.Patients & methods: In this retrospective study, several HNC patients (n = 179) treated at Zhejiang Provincial People's Hospital from January 2019 to June 2023 were considered. The recruited subjects were divided into modeling and validation groups. The experimental data on clinical characteristics and treatment were collected and analyzed to identify predictive factors for severe RIOM based on the logistic regression approach.Results: The results indicated that severe RIOM occurred in 55.3% of patients. Accordingly, significant predictors included smoking history, diabetes, concurrent chemotherapy, cumulative radiation dose and weight loss of ≥5% in relative to admission weight. A nomogram based on these factors was validated, showing excellent predictive accuracy.Conclusion: In summary, the predictive model could effectively identify high-risk patients for severe RIOM, enabling the design of targeted interventions and improving patient management during radiotherapy.

2024-09-01·Journal of Stomatology, Oral and Maxillofacial Surgery

Analysis of factors related to radiation-induced oral mucositis in patients with head and neck tumors undergoing radiotherapy

Article

作者: Li, Xue-Dong ; Yang, Wei-Xia ; Deng, Yi-Kun ; Tan, Xiao-Juan ; Liu, Jing-Jing ; Hu, Xin ; Xu, Li-Ming

OBJECTIVETo explore the risk factors of radiation-induced oral mucositis (RIOM) in patients with head and neck tumors undergoing radiotherapy.METHODSA retrospective collection was conducted on patients with head and neck tumors who underwent radiotherapy and chemotherapy in our hospital from April 1, 2015 to April 1, 2019. They were divided into an incidence group (n = 48) and a non-incidence group (n = 76) based on whether RIOM occurred, and relevant data was collected for comparison.RESULTSThere were statistically significant differences between the two groups of patients in terms of tumor type, smoking percentage, education level percentage, tumor stage, oral mucosal inflammation stage, radiotherapy dose, mucosal protectants, and oral hygiene condition(P < 0.05); The regression analysis results showed that smoking (OR=1.274, 95 % CI: 1.095-2.007), high-dose radiotherapy (OR=1.223, 95 % CI: 1.098-2.077), and poor oral hygiene (OR=1.367, 95 % CI: 1.024-2.890) were risk factors for RIOM.CONCLUSIONSmoking, high-dose radiotherapy, and poor oral hygiene were risk factors for RIOM in head and neck patients after radiotherapy and chemotherapy.

项与放射性口腔黏膜炎相关的新闻（医药）

2024-09-17

·BioSpace

EpicentRx Receives Highly Competitive US Department of Defense (DoD) Translational Award to Develop RRx-001 as a Neuroprotective Medical Countermeasure

The highly competitive award from the CDMRP Toxic Exposures Research Program will fund the development of EpicentRx’s small molecule, RRx-001 (nibrozetone), as a neuroprotective agent and medical countermeasure against neurotoxic chemical exposures. TORREY PINES, Calif. , Sept. 17, 2024 /PRNewswire/ -- EpicentRx and A/Prof. Richard Gordon from the Queensland University of Technology’s Translational Research Institute (QUT-TRI) have been awarded funding from the US Department of Defense Congressionally Directed Medical Research Programs (CDMRP). The Translational Research Award, funded through the CDMRP Toxic Exposures Research Program (TERP), will fund research at both EpicentRx and QUT-TRI in Brisbane, Australia to enable bench-to-bedside development of the proprietary EpicentRx small molecule radio- and chemoprotector, RRx-001 (nibrozetone), as a medical countermeasure for chemical exposures linked to neurodegeneration. Growing evidence suggests that increased exposure to chemicals from industrialization, and in occupations such as military service, firefighting and farming, could be responsible for the rising global incidence of neurological disorders such as Parkinson’s disease and Amyotrophic Lateral Sclerosis. Acute and chronic exposures to specific classes of chemicals such as pesticides, organophosphates, heavy metals and some solvents, have been shown to directly and indirectly damage the central nervous system to either trigger or worsen neurological decline. In both clinical and preclinical studies, RRx-001 has been shown to protect healthy cells from toxicity induced by radiation and chemotherapy. Based on positive results in preclinical models, as well as new insights into the drug’s mode of action, the CDMRP TERP award of $1.6 million for three years will fund further development of RRx-001 and new formulations that can effectively protect the central nervous system and gut-brain axis from damage caused by chemical exposures. “The unique pharmacological properties of RRx-001 and its broad protective activity in the central nervous system make this drug an excellent candidate for neuroprotection and deployment as a medical countermeasure for acute and chronic chemical exposures,” commented co-PI Dr. Richard Gordon , an internationally recognized neuroscientist and toxicologist. “We are honored to be selected for this award from the U.S. DoD,” said Dr. Tony Reid , Chief Executive Officer. “These non-dilutive funds will advance the clinical development of RRx-001 as a potential treatment for veterans that have suffered from the effects of neurotoxicity.” The CDMRP Translational Research Award will enable the next phase development for RRx-001 and builds on ongoing work funded by the Michael J. Fox Foundation, Shake It Up Australia Foundation and FightMND to evaluate the therapeutic efficacy of RRx-001 for neurodegenerative diseases and its protective mechanisms of action in the central nervous system. About EpicentRx: EpicentRx Incorporated is a privately held biopharmaceutical company with two innovation-driven platforms of which nibrozetone (RRx-001) and AdAPT-001 are the lead compounds, respectively. The company’s mission is disease remission, which it hopes to accomplish with novel, well-tolerated therapies that target a diverse range of unmet needs in cancer and non-cancer indications. Nibrozetone (RRx-001), a multimechanistic small molecule, is designed and currently under clinical investigation to preferentially target diseased tissues like tumors even as it shields normal cells from harm. A late-stage clinical trial named KEVLARx is currently ongoing for protection against chemoradiation-induced oral mucositis in first line head and neck cancer. Learn more at . The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $1,599,985.00), through the Toxic Exposures Research Program under Award Nos. HT9425- 24-1-0982 and HT9425-24-1-0983. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Media Contact: Ashley Thomaz Email: ashleyt@mcspr.com View original content to download multimedia: SOURCE EpicentRx, Inc.

临床研究

2024-04-10

·米内网

中药新药爆发了！4000亿市场11款新药来袭，康缘、悦康、天士力发力，中药股研发加码

精彩内容中药新药研发火热！近日，康缘药业龙七胶囊申报NDA，方盛制药益气消瘤颗粒申报IND，苏中药业痔瘘熏洗颗粒获批临床……今年以来，国内已有5个中药新药获批上市，创同期历史新高；11款中药新药报产，数量明显提升；18款中药新药申报IND，呼吸、妇科、消化领域研发火热。正值上市公司业绩披露期，多家中药企业净利润大增、研发投入加码。5款中药新药获批上市！齐进、卓和、成都华西上榜2024年一季度，国家药监局共批准了5个中药新药上市。其中，中药1.1类创新药有3款，包括湖北齐进药业的儿茶上清丸、卓和药业的九味止咳口服液、成都华西天然药物的秦威颗粒；中药3.1类新药（即古代经典名方中药复方制剂）有2个，包括武汉康乐药业的芍药甘草汤颗粒、华润三九的苓桂术甘颗粒。2024年一季度国内获批上市的中药新药来源：米内网中国申报进度（MED）数据库中药新药进入收获期，2024年一季度获批数量创同期历史新高。在过去的2023年，国内共有9个中药新药获批上市，但年内首款中药新药于2023年6月8日获批上市。2022年一季度，国家药监局仅批准了北京珅诺基的淫羊藿素软胶囊上市。2021年一季度，国家药监局批准了抗疫“三方”新药清肺排毒颗粒、化湿败毒颗粒、宣肺败毒颗粒上市。湖北齐进药业的儿茶上清丸又称“荆门上清丸”，源于明末清初，迄今流传400余年。该药具有清热退火、解毒敛疮、止痛之功效，用于轻型复发性阿弗他溃疡上焦实热证。米内网数据显示，2022年中国三大终端六大市场（统计范围详见本文末）口腔溃疡中成药销售额超过6亿元。儿茶上清丸是荆门市首个获批的国家1类新药，也是国内首个口腔溃疡中药1.1类创新药。九味止咳口服液来源于邹学熹教授临床经验方，具有宣肺止咳之功效，用于治疗急性支气管炎风热咳嗽证，处方由矮地茶、枇杷叶、麻黄、苦杏仁、薄荷、陈皮、竹茹、鱼腥草和炙甘草组成。该药由苏州玉森新药负责研究开发，卓和药业负责上市销售，双方共享产品上市后利润。米内网数据显示，2022年中国三大终端六大市场止咳祛痰平喘中成药销售额超过240亿元。成都华西天然药物的秦威颗粒（曾用名：拈痛祛风颗粒）由秦皮、威灵仙、当归、川芎组成，具有清热除湿祛风、活血通络止痛之功效，用于治疗急性痛风性关节炎风湿郁热证。米内网数据显示，2022年中国三大终端六大市场风湿性疾病中成药销售额超过115亿元。目前国内已有2款痛风中药1.1类创新药虎贞清风胶囊、秦威颗粒获批上市。11款中药新药报产！康缘、悦康、天士力紧盯4000亿市场4月4日，康缘药业的中药1.1类创新药龙七胶囊上市申请获得承办。该药是由三七等十味中药材组成的中药复方制剂，具有祛痰化瘀、清肺消积之功效，用于治疗肺癌，有望成为国内首个抗肿瘤中药创新药。近年来国内中药新药研发热潮高涨，2022年共有10款中药新药的上市申请获得承办，2023年共有23款中药新药的上市申请获得承办。2024年一季度便有10款中药新药的上市申请获得承办，较2023年一季度（6款）增逾66%。2024年至今中药新药申请上市情况中药1.1类创新药有6个，包括悦康药业的通络健脑片和紫花温肺止嗽颗粒、健民集团的牛黄小儿退热贴、康缘药业的龙七胶囊、东方运嘉的小儿黄金止咳颗粒、瑞和制药的喉喑清胶囊。其中，儿科用药有2款，米内网数据显示，2022年中国三大终端六大市场儿科中成药销售额超过160亿元。中药3.1类新药有5个，包括天士力的枇杷清肺饮颗粒和温经汤颗粒、仲景宛西制药的枇杷清肺颗粒、吉林敖东的一贯煎颗粒、药都樟树的二冬颗粒。其中，消化系统疾病用药、呼吸系统疾病用药各占2个，妇科用药占1个。目前国内已有20款中药3.1类新药申报NDA，主要集中在妇科用药（7个）、呼吸系统疾病用药（6个）。米内网数据显示，2022年中国三大终端六大市场中成药销售额接近4000亿元，同比增长超5%。从治疗领域上看，心脑血管疾病中成药以超960亿元的销售额领跑，位列第二的呼吸系统疾病中成药销售额超800亿元，消化系统疾病中成药则以接近420亿元的销售额位列第三。中国三大终端六大市场中成药销售情况（单位：万元）来源：米内网格局数据库自2020年新版中药注册分类实施以来，国内尚未有心脑血管疾病中药1类创新药获批上市。目前仅有悦康药业的中药1.1类创新药通络健脑片、中药1.2类创新药注射用羟基红花黄色素A上市申请在审中，预计公司将拿下国内首款心脑血管疾病中药1类创新药。18款中药新药申报IND，中药企业研发加码步入4月，3款中药新药IND申请迎来进展。7日，方盛融大的中药1.1类创新药益气消瘤颗粒临床试验申请获承办，用于治疗子宫肌瘤；4日，白云山和记黄埔的2.3类中药改良型新药丹红化瘀口服液临床试验申请获承办，拟新增适应症；2日，中科院新疆理化所的中药1.1类创新药司亚丹凝胶临床试验申请获承办，用于治疗白癜风。截至4月9日，国内已有18款中药新药的临床试验申请获承办，多款创新药聚焦呼吸、妇科、消化领域。其中，中药1类创新药有13个、中药2类改良型新药有5个，涉及康缘药业、雷允上、苏中药业、白云山和记黄埔、方盛制药等知名中药企业。2024年至今中药新药申报临床情况18款中药新药中，江苏中雍红瑞的中药1.1类创新药香术平胃散（治疗慢性非萎缩性胃炎脾胃虚寒证）、苏中药业的中药1.1类创新药痔瘘熏洗颗粒（用于混合痔术后症状改善）、新奇康药业的2.3类中药改良型新药西帕依固龈液（用于放射性口腔黏膜炎）、康缘药业的中药1.1类创新药羌芩颗粒（治疗流行性感冒）、广州中医药大学的中药1.1类创新药青杏颗粒（治疗普通感冒）已相继获批临床。中药新药研发的推进离不开企业的重金投入，业绩的增长可为企业研发投入提供有力的支撑。正值上市公司年报披露期，多家中药企业的业绩传来喜讯。截至4月9日，23家中药企业已披露2023年年报，其中15家企业净利润增逾10%、11家企业研发费用增逾10%。康缘药业2023年净利润5.37亿元，同比增长23.54%；研发费用7.72亿元，同比增长27.40%。华润三九2023年净利润28.53亿元，同比增长16.50%；研发费用7.15亿元，同比增长20.30%。同仁堂2023年净利润16.69亿元，同比增长16.92%；研发费用2.80亿元，同比增长28.68%。太极集团2023年净利润8.22亿元，同比增长131.99%；研发费用2.34亿元，同比增长113.52%。达仁堂2023年净利润9.87亿元，同比增长14.49%；研发费用1.85亿元，同比增长20.56%。……资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准临床申请申请上市

2023-11-06

·PRNewswire

EpicentRx To Present Nibrozetone (RRx-001) Data on Parkinson's Disease and ALS/MND at Neuroscience 2023

TORREY PINES, Calif., Nov. 6, 2023 /PRNewswire/ -- EpicentRx, Inc. ("EpicentRx"), a clinical-stage biotechnology company with two therapeutic platforms that address cancer and inflammatory diseases, has been selected for oral and poster presentations at the prestigious Society for Neuroscience's Neuroscience 2023, an international conference taking place in Washington, D.C. from Saturday, November 11 to Wednesday, November 15, 2023. The oral presentation by Dr. Richard Gordon, associate professor at the Queensland University of Technology and an internationally recognized expert on inflammasome signaling in neurodegenerative diseases, will present groundbreaking data on nibrozetone (RRx-001), a Phase 3 small molecule anticancer and chemoprotective agent with central nervous system (CNS) permeability and nanomolar potency against inflammasome activation. "Nibrozetone (RRx-001) has the potential to be an attractive neuroprotective treatment for disease modification of Parkinson's disease, an area of medical research that needs new and improved therapies," said Dr. Richard Gordon. "It has shown great potential against the blood-brain barrier in neurogenerative diseases and I'm looking forward to sharing the latest science and research on this potentially game-changing treatment." Details on the presentation include: Title: The CNS-permeable NLRP3 inhibitor RRx-001 is neuroprotective in experimental models of Parkinson's disease (NANO86.06) Session Title: Parkinson's Disease: Preclinical Models and Therapeutic Strategies Location: WCC 147A Session Date and Time: Wednesday, November 15 at 1:00pm ET EpicentRx will also showcase a poster at the conference titled, "PSTR200.18 – Evaluation of the phase-3 clinical candidate RRx-001 as a novel therapeutic agent for Amyotrophic Lateral Sclerosis." Following Neuroscience 2023, EpicentRx's Chief Executive Officer, Dr. Tony Reid, will present at the 2023 Inflammasome Therapeutics Summit on Thursday, November 30 at 9:30am ET. Dr. Reid's talk is entitled, "Exploring the Development of RRx-001: the NLRP3 Small Molecule Inhibitor for a Variety of Inflammatory Diseases." About Nibrozetone (RRx-001) Nibrozetone (RRx-001) is a highly selective NLRP3 inhibitor, Nrf2 agonist, and hypoxic nitric oxide donor with anti-inflammatory and antioxidant properties. Nibrozetone (RRx-001) is under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and a soon-to-start Phase 2b trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a medical countermeasure for toxic exposures, and as a treatment for endometriosis and neurodegenerative diseases like Parkinson's and ALS/MND. About EpicentRx, Inc. EpicentRx Incorporated is a privately held biopharmaceutical company with two innovation-driven platforms of which nibrozetone (RRx-001) and AdAPT-001 are the lead compounds, respectively. The company's mission is disease remission, which it hopes to accomplish with novel, well-tolerated therapies that target a diverse range of unmet needs in cancer and non-cancer indications. Nibrozetone (RRx-001), a multimechanistic small molecule, is designed and currently under clinical investigation to preferentially target diseased tissues like tumors even as it shields normal cells from harm. It is in a Phase 3 trial called REPLATINUM for the treatment of small cell lung cancer (SCLC). A soon-to-start trial is KEVLARx for protection against chemoradiation-induced oral mucositis in first line head and neck cancer. Media Contact: Oliwia Barteczko (908) 234-9900 [email protected] SOURCE EpicentRx, Inc.

临床2期临床3期