Radiation is commonly used to treat cancer in the head and neck, however, this can lead to a serious complication called osteoradionecrosis (ORN), where there is necrotic (dead) open bone inside or outside of the mouth. This complication is difficult to treat, involves large healthcare costs, and can have devastating effects on quality of life.
Two common adjuncts used in treatment of ORN are hyperbaric oxygen therapy (HBOT), which may requires up to 60 treatments at a specialized clinic where patients are treated with high concentrations of oxygen using special chambers, and a less complex option called PENTOCLO which involves treating patients with several antibiotics followed by a combination of other oral medications taken for at least 1 year.
This pilot study will be guide the design of a definitive trial to examine if the combination of HBOT and a modified PENTOCLO protocol together is better than the current standard treatment of HBOT alone. Outcomes will include pain, side effects and the need for surgery in patients with ORN. Specifically, the results of this small, pilot study will help to inform the design of a future larger study.

开始日期2024-05-01

申办/合作机构

Sunnybrook Health Sciences Centre

NCT06263517 / Recruiting临床2/3期

Adaptative, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled, Clinical Trial, on the Efficacy and Tolerability of Different Escalating Doses of Intra-articular Clodronate in Patients With Painful Knee Osteoarthritis

The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.
The main questions it aims to answer are:
in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate
in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III
in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA

开始日期2023-10-12

申办/合作机构

Società Prodotti Antibiotici SpA

[+1]

EUCTR2021-003124-33-IT / Unknown status临床2/3期

Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled, clinical trial, on the efficacy and tolerability of different escalating doses of intra-articular clodronate in patients with painful knee osteoarthritis - SPA-S-899-01-21

开始日期2023-05-15

申办/合作机构-

100 项与氯膦酸二钠相关的临床结果

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100 项与氯膦酸二钠相关的转化医学

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100 项与氯膦酸二钠相关的专利（医药）

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项与氯膦酸二钠相关的文献（医药）

2024-12-01·Molecular biology reports

Mycobacterium marinum mediates regulation of prostaglandin E2 expression on host immune response through cyclooxygenase pathway

Article

作者: Xu, Cheng ; Zhou, Lei ; Chen, Zhenhua ; Mo, Liyi ; Lin, Bingyao ; Luo, Yanwen ; Lin, Dongzi ; Tian, Honghong ; Wang, Xuezhi

PURPOSE:

Investigate the role of COX signaling in activating the PGE2-EP2 pathway.

METHODS:

Utilized a marine Mycobacterium infection model in zebrafish. Marine mycobacteria were stained with fluorescein isothiocyanate. The COX inhibitor indomethacin, EP2 receptor inhibitor AH6809, EP4 receptor inhibitor AH23848 and clodronate Liposomes were used to investigate the role of COX, EP2, EP4 and macrophage whether participating in combat marine mycobacterial infection. The expression level of the target gene was detected using real-time fluorescence quantitative PCR instrument.

RESULTS:

The findings revealed that larvae exposed to the COX inhibitor indomethacin or the EP2 receptor inhibitor AH6809 demonstrated a significantly higher mortality rate due to marine mycobacterium infection than those in the control group. Administration of exogenous prostaglandin E2 (PGE2) rescued the survival of zebrafish infected with marine mycobacteria and treated with indomethacin. Additionally, a significant reduction in survival rate was noted in macrophage-depleted zebrafish infected with marine mycobacteria.

CONCLUSION:

The host may combat marine mycobacterium infection via COX signaling, which activates the PGE2-EP2 pathway and mediates macrophage resistance.

2024-03-15·American journal of respiratory and critical care medicine

Specific Inhibition of Orai1-mediated Calcium Signalling Resolves Inflammation and Clears Bacteria in an Acute Respiratory Distress Syndrome Model

Article

作者: Ahmad, Saira ; Thickett, David R ; Greenbaum, Alon ; Mahida, Rahul Y ; Wrennall, Joe A ; Tarran, Robert ; Sekhri, Malika ; Ignar, Diane M ; Goriounova, Alexandra S ; Moran, Timothy P ; Iskarpatyoti, Jason A ; Sassano, M Flori ; Krajewski, Krzysztof ; Ghosh, Arunava ; Tilley, Stephen L ; Abdelwahab, Sabri H ; Rai, Mani ; Voeller, Alexis

Rationale: Acute respiratory distress syndrome (ARDS) has an unacceptably high mortality rate (35%) and is without effective therapy. Orai1 is a Ca²⁺ channel involved in store-operated Ca²⁺ entry (SOCE), a process that exquisitely regulates inflammation. Orai1 is considered a druggable target, but no Orai1-specific inhibitors exist to date. Objectives: To evaluate whether ELD607, a first-in-class Orai1 antagonist, can treat ARDS caused by bacterial pneumonia in preclinical models. Methods: ELD607 pharmacology was evaluated in HEK293T cells and freshly isolated immune cells from patients with ARDS. A murine acute lung injury model caused by bacterial pneumonia was then used: mice were infected with Pseudomonas aeruginosa, Staphylococcus aureus, methicillin-resistant S. aureus, or multidrug-resistant P. aeruginosa and then treated with ELD607 intranasally. Measurements and Main Results: ELD607 specifically inhibited SOCE in HEK293T cells with a half-maximal inhibitory concentration of 9 nM. ELD607 was stable in ARDS airway secretions and inhibited SOCE in ARDS immune cells. In vivo, inhaled ELD607 significantly reduced neutrophilia and improved survival. Surprisingly, Orai1 inhibition by ELD607 caused a significant reduction in lung bacteria, including methicillin-resistant S. aureus. ELD607 worked as an immunomodulator that reduced cytokine levels, reduced neutrophilia, and promoted macrophage-mediated resolution of inflammation and clearance of bacteria. Indeed, when alveolar macrophages were depleted with inhaled clodronate, ELD607 was no longer able to resolve inflammation or clear bacteria. Conclusions: These data indicate that specific Orai1 inhibition by ELD607 may be a novel approach to reduce multiorgan inflammation and treat antibiotic-resistant bacteria.

2024-02-01·The American journal of pathology

Macrophage Activation in Synovitis and Osteoarthritis of Temporomandibular Joint and Its Relationship with the Progression of Synovitis and Bone Remodeling

Article

作者: Li, Huimin ; Liu, Xin ; Hu, Shiyu ; Long, Xing ; Ke, Jin ; Jiang, Henghua

This study investigates the regulatory mechanisms of synovial macrophages and their polarization in the progression of temporomandibular joint osteoarthritis (TMJOA). Macrophage depletion models were established by intra-articular injection of clodronate liposomes and unloaded liposomes. TMJOA was induced by intra-articular injection of 50 μL Complete Freund's Adjuvant and the surgery of disc perforation. The contralateral joint was used as the control group. The expression of F4/80, CD86, and CD206 in the synovium was detected by immunofluorescence staining analysis. Hematoxylin and eosin staining and TMJOA synovial score were detected to show the synovial changes in rat joints after TMJOA induction and macrophage depletion. Changes in rat cartilage after TMJOA induction and macrophage depletion were shown by safranin fast green staining. The bone-related parameters of rats' joints were evaluated by micro-computed tomography analysis. The TMJOA model induced by Complete Freund's Adjuvant injection and disc perforation aggravated synovial hyperplasia and showed a significant up-regulation of expression of F4/80-, CD86-, and CD206-positive cells. F4/80, CD86, and CD206 staining levels were significantly decreased in macrophage depletion rats, whereas the synovitis score further increased and cartilage and subchondral bone destruction was slightly aggravated. Macrophages were crucially involved in the progression of TMJOA, and macrophage depletion in TMJOA synoviocytes promoted synovitis and cartilage destruction.

项与氯膦酸二钠相关的新闻（医药）

2023-05-30

·Pharmaceutical Technology

Abiogen acquires EffRx to fortify bone disease portfolio

Akosua Mireku @AkosuaMireku1 A man sitting on living room sofa holding his painful shoulder. Abiogen develops drugs for osteoarthritis. Credit: RealPeopleGroup via Getty Images The Italian pharmaceutical company Abiogen Pharma completed an acquisition of a 97.09% stake in the Swiss orphan conditions-focused EffRx Pharmaceuticals on May 29. This deal follows Abiogen’s recent acquisition of the Cologne, Germany-based Altamedics in December 2022. Altamedics specialises in pharmaceutical distribution in hospital settings. The €8 million ($8,559,480) deal was Abiogen’s first move in its global expansion plan and the deal with EffRx is a continuation of this. Abiogen Pharma specialises in osteoarticular and bone metabolism diseases amongst other therapy areas. The company has developed three bisphosphonates, clodronate, alendronate and Nerixia (neridronate), for the treatment of bone pathologies such as osteoarthritis . Bisphosphonates are drugs that slow the progression of bone loss. EffRx has received several European regulatory approvals for drugs in its portfolio . For example, in July 2022, EffRx launched its paediatric adrenal insufficiency replacement therapy Alkindi (hydrocortisone) in Switzerland. Alkindi is one of EffRx’s three marketed drugs. The company developed and launched Binosto (alendronate sodium) as the first and only buffered solution for osteoporosis. The European Medicines Agency has also approved Efmody for the treatment of congenital adrenal hyperplasia medicine in patients ages 12 years and above in the European Union. The company’s last deal included an exclusive license agreement with the Cardiff, UK-headquartered specialty pharmaceuticals company Diurnal group for the commercialisation of Efmody (hydrocortisone) in Switzerland. In Italy, Abiogen began distributing its bisphosphonates in 2014 and has since seen some successful drug approvals. The biotech transferred the rights for alendronate to Merck which marketed the drug under the brand name Vancapsi. The Italian health authorities also gave Abiogen’s Nerixia the country’s first rare disease designation for Osteogenesis Imperfecta and Complex regional pain syndrome, for which the drug is now approved in Italy. Separate from drug development, the Italian company also offers contract manufacturing and clinical supply services. In a press release , Abiogen’s International Business Unit Head, Prisca Di Martino said, “We are working towards developing Abiogen into an international business, without losing sight of our nature as an Italian and family-run undertaking, and we are pursuing this target by entering into agreements with foreign businesses that share our goals and therapeutic areas.”

上市批准并购引进/卖出

2022-10-27

·药智网

200亿市场“狼烟四起”，骨质疏松研发赛一触即发！谁能称霸？

曾经有一份绝佳的治疗机会摆在我面前，我却没有珍惜。直到错过了以后，才追悔莫及。如果上天能够再给我一次重来的机会，我会说一句“我抓紧吃药！”这段话虽然是个玩笑，但对于骨质疏松患者来说，很可能是现实。据了解，骨质疏松症(Osteoporosis，OP)早期通常没有明显临床表现，患者往往在出现疼痛、脊柱变形和骨折等情况后才发现自己患病，因此被认为是“沉默的杀手”。“杀手”无处不在！破解杀机的骨质疏松药物，进展如何？200亿市场“狼烟四起”，谁能称霸？200亿市场“狼烟四起”据2018年我国国家卫健委发布的骨质疏松症流行病学调查结果，我国骨量减少及OP患者数量已达到3亿以上，50岁以上人群OP患病率为19.2%。而65岁以上人群OP患病率达到32.0%，其中女性为51.6%。随着全球老龄化的加剧，OP已成全球最重要的健康科学问题之一。2018年全球骨质疏松症药物市场规模高达115亿美元。而我国是全球骨质疏松症患者人数最多的国家。2017年，我国骨质疏松药物市场规模已超过200亿元。目前，药物是治疗骨质疏松的最佳手段之一。按作用机制，目前临床上的OP治疗药物大致可分为：骨骼健康基础用药、骨吸收抑制剂、骨形成促进剂、钙吸收促进剂以及其他机制类药物。骨骼健康基础用药主要为钙剂和维生素D，主要用于儿童和青少年。钙吸收促进剂包括骨化三醇、阿法骨化三醇。骨吸收抑制剂主要包括降钙素类（鳗鱼降钙素和鲑鱼降钙素）、双磷酸盐类、地舒单抗和选择性雌激素受体调节剂（如雷洛昔芬）。促进骨形成药物包括特立帕肽和阿巴洛肽，主要治疗人群是对其他治疗药物不敏感的严重OP患者和越来越年轻化的绝经后女性OP患者。表1 部分抗骨质疏松症药物及其分类资料来源：公开资料钙吸收促进剂是改善OP患者常用的一种药物干预方式，其中艾地骨化醇是一种新型的活性维生素D3类似物，具有创新突破的双重作用机制，不仅可有效抑制皮质内骨吸收，增加皮质周长、体积骨密度和股骨颈皮质骨量，从而改善股骨颈的生物力学特性，还能有效促进骨塑形，最终可提高骨小梁连续性，增强骨小梁的形成，更有效的降低骨折风险。2020年12月，罗氏旗下日本中外制药株式会社开发的艾地骨化醇软胶囊在国内被批准用于治疗绝经后女性OP，商品名为艾地罗。原研骨化醇软胶囊市场表现不错，据悉其2020年全球销售额高达8.89亿美元。然而，艾地骨化醇即将实现国产化，今年10月9日，泰丰生物已取得艾地骨化醇软胶囊首仿生产批件。双膦酸盐类是目前临床上应用最为广泛的抗OP药物，它们是焦膦酸盐的稳定类似物，其特征为含有P-C-P基团。由于与骨骼羟磷灰石有高度亲和力，双膦酸盐特异性结合到骨转换活跃的骨表面上，抑制破骨细胞的成熟与活跃，从而抑制骨吸收。不仅可以防止骨丢失，双膦酸盐还可以使骨量增加，提高腰椎和髋部骨密度，降低椎体及髋部等部位骨折风险。目前，双膦酸盐类药物已从第一代发展到第三代，国内临床应用成熟的品种有10多个，如第一代的依替膦酸钠、氯屈膦酸钠；第二代的氯膦酸钠、帕米膦酸钠，第三代的阿仑膦酸钠、利塞膦酸钠、唑来膦酸、伊班膦酸钠和英卡膦酸钠。近年来，国内双膦酸盐类药物市场整体保持增长趋势，但增长速度已经放缓，据悉2020年销售额为30.04亿元。从具体品种来看，第三代的唑来膦酸、伊班膦酸钠市场占比较大。地舒单抗也是抗OP药物中一颗新星，它是一种靶向RANKL的全人化单克隆IgG2抗体，被批准用于具有骨折高风险的绝经后女性OP，以及用于治疗具有骨折高风险的OP男性患者，增加骨量，商品名为Prolia。研究显示，采用地舒单抗治疗3年可显著降低新发椎体骨折风险达68%，降低再骨折风险46%，治疗10年可降低再骨折风险达到59%。一项随访10年的研究发现地舒单抗可持续增加绝经后骨质疏松症患者的骨密度，并降低其椎体和髋部等骨折的风险。而且，地舒单抗还被批准用于多发性骨髓瘤和实体肿瘤骨转移患者中骨相关事件的预防（SREs）、骨巨细胞瘤(GCTB)成人和骨骼成熟的青少年患者的治疗以及对双膦酸盐难治的恶性肿瘤高钙血症（HCM），商品名为Xgeva。地舒单抗由安进研发，上市后销售额一路攀升，Proli 2021年全球销售额高达32.48亿美元。然而，地舒单抗于2020年6月才被NMPA批准用于治疗骨折高风险的绝经后妇女的OP，商品名为普罗力。目前，国内有十余家企业开始布局地舒单抗生物类似物市场，其中齐鲁制药、博安生物和迈威生物已先后递交其生物类似物上市申请。表2 近年来Prolia销售情况（亿美元）促进骨形成药物中的特立帕肽、阿巴洛肽均属于甲状旁腺激素（PTH）类似物，不过仅特立帕肽在国内获批。特立帕肽最初由礼来开发，被批准用于治疗具有高骨折风险的绝经后妇女及男性OP患者，商品名为Porteo。据悉，Porteo销售额于2017年达到峰值（17.49亿美元），但近几年销售额开始下滑，2021年下降至8.02亿美元。谁能笑傲“骨质疏松”江湖？除了礼来的特立帕肽，目前联合赛尔、信立泰开发的特立帕肽相关产品也已在国内获批。阿巴洛肽最初由法国Ispen开发，后授权给Radius Health，2017年4月被FDA批准用于具有骨折高风险的绝经后OP女性患者，商品名为Tymlos。据悉，Tymlos的销售额已由2017年的12百万美元攀升至2020年的208.40百万美元。而且，近年来全球监管机构还批准了一款抗OP新药，即安进/优时比Evenity（Romosozumab）。该药是一种靶向骨硬化蛋白（Wnt信号通路抑制剂）的人源化IgG2单克隆抗体，通过与骨硬化蛋白结合，拮抗其活性，阻断sclerostin-LRP-5/6通路，从而促进新骨形成并减少骨吸收。研究发现，该药能够增加脊柱、全髋关节和股骨颈骨密度，疗效优于特立帕肽和阿屈膦酸盐。而且，该药能够增加骨形成标志物，减少骨吸收标志物。Romosozumab2019年1月，Romosozumab率先在日本被批准用于降低骨折高危男性和绝经后女性OP患者的骨折风险并增加骨密度，2019年4月在美国被批准用于治疗有OP骨折史、伴多骨折危险因素或经其他治疗方案失败（或药物不耐受）绝经后女性的OP。该药通过皮下注射给药，每月一次。据悉，在美国市场，Romosozumab定价为每剂1825美元，12个月疗程合计达21900美元。据安进财报，Evenity 2020年、2021年销售额分别为3.5亿美元、5.30亿美元。此外，目前全球还有几款在研OP药物。如创胜集团的TST002(Blosozumab)（II期临床）、恒瑞医药的SHR-1222（I期临床）、信立泰的SAL056（III期临床）和联康集团的Uni-PTH。TST002(Blosozumab)是一种针对严重OP的人源化抗硬骨素单抗，具有增强骨合成代谢和抗骨吸收的双重作用，可促进骨骼形成并抑制骨质流失，从而能快速提升骨骼密度和增加骨骼强度。该药是由礼来最早研究开发，2019年创胜集团获得其在大中华区的开发及商业化授权。SHR-1222也是一款靶向硬骨的单抗药物。在OVX模型中，SHR-1222结合并抑制硬骨素，具有竞争性的体内疗效。SHR-1222剂量依赖性地增加全身和腰椎骨密度。SAL056是信立泰开发的每周注射一次特立帕肽冻干制剂，用于骨折高风险的绝经后妇女OP的临床试验已进入3期。Uni-PTH是一种合成代谢（骨骼生长）剂，用于治疗骨质疏松及骨痛。其治疗机制与市面上现有的产品有极大差别。相较于抑制骨吸收的产品，Uni-PTH可有效刺激静止的骨表面生成新骨。过刺激新骨生成，Uni-PTH可以在六个月的治疗期间快速提升骨骼品质并恢复骨质密度，因此降低骨折风险和骨痛情况，对于中重度骨质疏松和骨痛患者特别有效。而且，第二代Uni-PTH在第一代Uni-PTH的基础上进行了剂型改良，更方便患者使用。声明：如需转载，请务必注明文章作者和来源。如涉及作品内容、版权和其它问题，请您留言，我们将在第一时间删除。责任编辑 | 八角转载开白 | 马老师 18323856316（同微信）药智网原创作品 | 尽情分享朋友圈 | 转载请联系授权— Tips —如果您有医药行业相关的线索或对医药政策、研发创新、资本市场、产业发展有深度观察欢迎投稿给我们马老师 18323856316（同微信）邮箱：maxuelian@yaozh.com 阅读原文，是昨天最受欢迎的文章哦

抗体免疫疗法生物类似药财报仿制药

2022-07-14

·PRNewswire

Study shows that selection of breast cancer patients for adjuvant bisphosphonate therapy based on Inbiomotion's MAFTEST® reduces the risk of death in comparison with current clinical guidance

MAFTEST® analyses of the NSABP-B34 and AZURE landmark clinical trials confirmed clinical utility of the MAFTEST® for selection of early-stage breast cancer patients that benefit from adjuvant clodronate treatment. Reduces the risk of death at 5 and 10 years by 26% and 23% respectively. Identifies almost twice as many patients able to benefit from the intervention than are selected using current clinical guidelines. Data published in Annals of Oncology, (33), SUPPLEMENT 3, S152, 2022. BARCELONA, Spain, July 14, 2022 /PRNewswire/ -- Inbiomotion SL, a company developing a unique single-gene-based biomarker for the personalized adjuvant treatment of early-stage (stage I-III) breast cancer patients, announces the results of comparing the clinical efficacy of implementing the proprietary MAFTEST® for selection of patients for adjuvant bisphosphonates therapy with current clinical guidance. The results were presented at the ESMO 2022 Breast Cancer Symposium. The data show that stratification of early breast cancer patients according to MAF status reduced the risk of death and relapse in MAF negative patients by 26% and 23% respectively, compared to a 12% and 15% reduction in the risk of death or relapse seen with stratification by menopausal status recommended by current ESMO and ASCO Clinical Guidelines. The data also indicate that adjuvant treatment with bisphosphonates should be avoided in MAF positive patients as the risk of death and relapse is increased 16% and 15% respectively in these patients. In addition, the study shows that the use of MAF status for selection of early breast cancer patients for treatment with bisphosphonates allows the treatment of young premenopausal patients currently excluded by existing clinical guidance. "The MAF biomarker allows a new paradigm for selection of patients for adjuvant bisphosphonate treatment of early breast cancer that not only identifies those patients that will benefit from treatment (MAF negatives) but also excludes patients that could be harmed (MAF positives). This new selection criteria not only reduces the risk of death and relapse for selected patients but also provides a new treatment option for young patients currently excluded from this treatment in current clinical practice," said Robert Coleman, Professor Emeritus, Department of Oncology and Metabolism, University of Sheffield, UK. Currently, clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of the broad population of early-stage breast cancer patients. However, they are recommended in the ASCO/CCO and ESMO clinical guidelines for adjuvant treatment of breast cancer in postmenopausal patients. The study shows that identifying MAF-negative patients for selection for adjuvant treatment with bisphosphonates outperforms current selection by menopausal status and could give more patients, particularly younger patients, the opportunity to benefit from adjuvant bisphosphonates, while avoiding potential harm (or no benefit), than solely using menopausal status as a selection criterion. "Our results indicate that adjuvant clodronate treatment has a large clinical benefit if restricted to MAF-negative patients," said Prof. Alexander Paterson, principal investigator of the NSABP-B34 clinical trial and Emeritus Clinical Professor at the Department of Oncology, University of Calgary. "Our data provide an objective criterion for patient selection for bisphosphonate adjuvant treatment that outperforms current selection based on menopausal status." "This study confirms our previous findings and the clinical utility of MAFTEST® as a unique tool for precision medicine in early breast cancer. Every year approximately 355,000 women are diagnosed with early breast cancer in Europe with a 10% risk of death at 5 years. Using MAF Test these deaths could be reduced by 26%, which would translate to 9,230 lives saved," said Joël Jean-Mairet, Executive Chairman of the Board of Inbiomotion. "We have discovered and developed a new biomarker, MAF gene amplification, that if used as selection criteria for adjuvant treatment with bisphosphonates improves the clinical outcome of breast cancer patients compared with current clinical practice, " said Prof. Roger Gomis, ICREA Research Professor at IRB Barcelona. "MAF Test is a biomarker that is easy to implement in any clinical pathology lab and should be considered for routine characterization of breast cancer tumors." Recently the MAFTEST® obtained the CE-mark as an in vitro diagnostic medical device for prognostic purposes. Since clodronate and other bisphosphonates are not approved by the regulatory agencies for use in adjuvant treatment of early-stage breast cancer patients, Inbiomotion's MAFTEST® is not authorized to be used as a companion diagnostic as described in the above-mentioned study. Reference articles: Impact of MAF selection of patients for adjuvant bisphosphonate therapy and comparison with current clinical guidance Robert Coleman, Roger R Gomis, Alexander H G Paterson. Full text article : (22)00461-6/fulltext MAF amplification and adjuvant clodronate outcomes in early-stage breast cancer in NSABP B-34 and potential impact on clinical practice Alexander H G Paterson et al. Full text article: Effect of MAF amplification on treatment outcomes with adjuvant zoledronic acid in early breast cancer: a secondary analysis of international, open-label, randomized, controlled, phase 3 AZURE (BIG 01/04) trial Robert Coleman et al. Full text article: (17)30603-4/fulltext Benefits and risks of adjuvant treatment with zoledronic acid in stage II/III breast cancer. 10 years follow-up of the AZURE randomized clinical trial (BIG 01/04) Robert Coleman et al. Full text article: About Inbiomotion: Inbiomotion SL, a company founded by Prof. Roger Gomis, is developing a unique single gene-based biomarker for the personalized adjuvant treatment of early-stage breast cancer patients. The biomarker has been technically and analytically validated. The results of the first trial using well annotated archived specimens of the AZURE registrational clinical trial, now confirmed in the NSABP-B34 trial, indicate its potential use as a companion diagnostic. The company holds over 200 patents and patent applications covering its proprietary FISH MAFTEST® and the use of bisphosphonates in the adjuvant treatment of early-stage breast cancer patients. About MAF: MAF (mesenchymal aponeurotic fibrosarcoma gene, an AP-1 family transcription factor) is expressed in primary cancer tumors. This is associated with increased metastasis, especially bone metastasis. MAF transcriptionally controls genes such PTHrP, which regulate metastasis-related cellular processes, including survival, initiation, metabolic rewiring, and particularly, adhesion to bone marrow–derived cells and osteoclast differentiation. These observations point to MAF having a key hierarchical role in metastasis. SOURCE Inbiomotion

ASCO会议

100 项与氯膦酸二钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03544	氯膦酸二钠	M05BA02	DB00720

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
骨转移癌	法国	-	1994-11-27
恶性肿瘤体液性高钙血症	加拿大	Bayer, Inc.	1992-12-31
骨病	-	-	1986-01-01
高钙血症	-	-	1986-01-01
骨质疏松症	-	-	1986-01-01

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
骨关节炎	临床3期	意大利	Abiogen Pharma SpA	-

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临床结果

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分期

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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


ASGCT2023	N/A	-	-	Clodronate liposomes	鏇鹽獵襯憲顧簾繭範糧(範淵衊窪蓋衊襯淵觸鹽) = 顧積衊製壓憲衊膚簾齋觸膚構淵獵淵簾蓋餘淵 (築製餘衊構襯蓋顧廠淵 )	-	2023-05-01
				Control (no clodronate pre-treatment)	鏇鹽獵襯憲顧簾繭範糧(範淵衊窪蓋衊襯淵觸鹽) = 鑰鹽衊餘窪蓋鹹衊範鬱觸膚構淵獵淵簾蓋餘淵 (築製餘衊構襯蓋顧廠淵 )
EULAR2010	N/A	膝关节炎	122	Clodronate i.v. 300mg/die	餘網衊鏇糧鹽齋構製淵(選餘淵獵範獵蓋淵窪獵) = 廠衊觸遞餘鹹構餘選製獵廠衊淵獵膚遞醖艱鏇 (願艱襯鹽顧簾夢獵襯範 )	-	2010-06-16
MRC PR04 and PR05 (Pubmed \| Lancet Oncol)	N/A	前列腺癌转移辅助	-	Sodium clodronate	夢繭選積網構構憲鏇築(製齋憲選膚衊築壓鹹襯): HR = 0.77 (95% CI, 0.6 ~ 0.98), P-Value = 0.032	积极	2009-09-01
				Placebo
ASCO2007	临床3期	骨转移癌	46	Oral Clodronate	膚願齋醖鹽繭齋齋願壓(積觸壓廠衊憲顧鏇廠築) = 餘築遞醖鬱鏇積獵鹹鑰觸繭顧膚壓製製膚顧築 (觸壓繭繭製願顧積範構 ) 更多	-	2007-06-20
				Oral Ibandronate	膚願齋醖鹽繭齋齋願壓(積觸壓廠衊憲顧鏇廠築) = 簾夢餘鏇憲積衊築簾簾觸繭顧膚壓製製膚顧築 (觸壓繭繭製願顧積範構 ) 更多
ASCO2006	N/A	早期乳腺癌辅助	268	Clodronate	淵齋鏇鑰獵鑰醖積鹹鬱(窪願簾憲鏇廠鑰餘構簾) = 襯壓鑰繭鑰衊簾鏇鬱憲蓋憲鏇選淵壓蓋遞廠廠 (蓋鏇繭淵淵鏇壓淵窪窪 ) 更多	-	2006-06-20
ASCO2005	N/A	乳腺癌	1,069	Oral clodronate 1600mg	願窪願憲鹽醖網繭觸觸(鹹鏇觸構觸窪顧糧鑰壓) = 餘壓積襯衊鏇選鬱艱蓋艱艱餘齋鬱鹹積餘艱齋 (鏇選鬱選憲鬱鹹蓋簾築, 0.010–0.021)	-	2005-06-01
ASCO2004	N/A	淋巴结阳性乳腺癌辅助	299	Clodronate 1600 mg daily	壓淵繭壓獵鏇獵壓壓艱(鹽糧構糧製獵獵膚積鏇) = 餘繭願衊窪淵糧艱鏇觸構簾觸顧糧顧壓製醖糧 (觸觸蓋網鏇蓋構鏇鹽鹹 ) 更多	不佳	2004-07-15
				clodronate (Control)	壓淵繭壓獵鏇獵壓壓艱(鹽糧構糧製獵獵膚積鏇) = 鏇糧製簾醖鏇夢壓齋鑰構簾觸顧糧顧壓製醖糧 (觸觸蓋網鏇蓋構鏇鹽鹹 ) 更多
NCT00009945 (Pubmed \| Drug Saf)	临床3期	乳腺癌辅助	1,079	Oral clodronate 1600 mg/day	膚襯衊繭選構鑰繭鬱糧(構範廠鑰鏇膚鑰鏇遞廠) = 願網築範餘夢蓋構鏇簾鏇襯蓋範衊壓糧廠壓鹹 (餘簾繭顧憲構鑰網淵積 ) 更多	-	2003-01-01
				Placebo	膚襯衊繭選構鑰繭鬱糧(構範廠鑰鏇膚鑰鏇遞廠) = 窪築網壓鑰構繭廠構網鏇襯蓋範衊壓糧廠壓鹹 (餘簾繭顧憲構鑰網淵積, 4.0 ~ 15.6) 更多
NCT00009945 (Pubmed \| J Urol)	临床3期	乳腺癌	3,323	Clodronate 1,600 mg/d	鹽衊範衊遞觸鹹窪憲鬱(廠繭蓋願醖簾觸築鑰醖): HR = 0.77 (95% CI, 0.56 ~ 1.08)	积极	2002-08-01
				Placebo