DX-01(DX-01) - 在研适应症：细菌性阴道炎，滴虫性阴道炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名-

靶点-

作用机制-

治疗领域

感染泌尿生殖系统疾病

在研适应症

细菌性阴道炎滴虫性阴道炎

非在研适应症-

原研机构

湖北东信药业有限公司

在研机构

长沙大地药物研究所（普通合伙）福州瀚力生物医学技术有限公司

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

2

项与 DX-01 相关的临床试验

CTR20140580 / Completed临床1期

观察DX01单剂量、多剂量给药后在健康女性受试者体内的血药浓度经时过程。

采用单中心、开放、平行、无对照、单周期的单剂量、多剂量阴道给药的试验方法，观察DX01给药后在健康女性受试者体内的血药浓度经时过程。评价DX01在中国人体内的吸收，分布，代谢，排泄的药代动力学过程，为DX01的药品注册和生产上市提供临床依据。

开始日期2014-11-09

申办/合作机构

福州瀚力生物医学技术有限公司

[+1]

CTR20140597 / Recruiting临床3期

DX01治疗滴虫阴道炎和细菌性阴道病的多中心、随机、盲法、阳性药物平行对照Ⅲ期临床试验

以甲硝唑栓为对照评价DX01治疗滴虫阴道炎、细菌性阴道病的有效性和安全性的多中心、随机、盲法、阳性药物平行对照临床试验

开始日期2014-09-15

申办/合作机构

福州瀚力生物医学技术有限公司

[+1]

100 项与 DX-01 相关的临床结果

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100 项与 DX-01 相关的转化医学

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100 项与 DX-01 相关的专利（医药）

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7

项与 DX-01 相关的文献（医药）

2020-11-01·Current microbiology4区 · 生物学

Screening for Candidate Genes Associated with Biocontrol Mechanisms of Bacillus pumilus DX01 Using Tn5 Transposon Mutagenesis and a 2-DE-Based Comparative Proteomic Analysis

4区 · 生物学

Article

作者: Xu, Lurong ; Li, Qiongjie ; Ma, Yifei ; Cheng, Jiejie ; Liu, Tong ; Chen, Yunpeng

A total of 1467 mutants of the biocontrol bacterium Bacillus pumilus DX01 were obtained by Tn5 insertional mutagenesis and subjected to the determination of antagonistic capabilities. Compared with the wild-type strain DX01, the mutant M25 was identified to have the most significant reduction in antagonistic capability against the phytopathogen Bipolaris maydis and extracellular proteinase activity. The integration site of the exogenous T-DNA in the genome of mutant M25 was revealed in the coding region of malony CoA-ACP transacylase (MCAT) gene (mcat), which belongs to a polyketide synthase (PKS) gene cluster, DX01pks of B. pumilus DX01. Furthermore, the whole DX01pks gene cluster was cloned using Illumina Solexa sequencing technology, and it has a modular framework different from the other two gene clusters involved in polyketide synthesis in B. amyloliquefaciens FZB42 (pks1) and B. subtilis 168 (pksX). Finally, in order to gain more insights into the molecular mechanisms of biocontrol of B. pumilus DX01, the changes in the relative level of expression of total proteins between the original strain DX01 and the mutant M25 were detected by 2-DE-based proteomic analysis. A total of twenty differentially expressed proteins were identified upon the mcat gene transposition mutagenesis. Of these proteins, seven proteins were up-regulated in expression level and the other proteins were down-regulated. Taken together, the results in this study showed that Tn5 transposon mutagenesis of B. pumilus DX01 can lead to a significant change of antiphytopathogen ability, and the DX01pks gene cluster possibly play a potential role in the biocontrol processes of this bacterium.

2011-07-01·Cancer chemotherapy and pharmacology4区 · 医学

Synergistic interactions between peloruside A and other microtubule-stabilizing and destabilizing agents in cultured human ovarian carcinoma cells and murine T cells

4区 · 医学

Article

作者: Anne Camille La Flamme ; Peter T. Northcote ; Ariane Chan ; Ian Paterson ; Anja Wilmes ; David O’Sullivan ; Clarissa Chandrahasen ; John H. Miller

PURPOSE:

Microtubule-stabilizing agents are an important class of anticancer compounds. Peloruside A and laulimalide bind to a different site on the microtubule to taxoid site drugs such as paclitaxel (Taxol(®)), docetaxel (Taxotere(®)), ixabepilone (Ixempra(®)), the epothilones, and discodermolide. The purpose of this study was to examine the synergistic interactions of these drugs when given in combination in relation to the differences in their binding sites on the microtubule.

METHODS:

Human ovarian carcinoma cells (1A9 cells) and murine T cells were treated with different combinations of microtubule-stabilizing or destabilizing agents. The compounds were given individually and in combination, and the antiproliferative activity was assessed to calculate a combination index (CI) from the equation: CI = D(1)/Dx(1) + D(2)/Dx(2) in which D(1) and D(2) are the concentrations of drug 1 and drug 2 that when given together give the same response as drug 1 and 2 alone (Dx(1) and Dx(2)). Thus, a CI value of less than 1.0 indicates a synergistic effect between the two drugs in which the response to the two drugs given together is greater than the additive response of the two drugs if given on their own.

RESULTS:

As anticipated from previous in vitro studies, peloruside A and laulimalide did not synergize with each other. They also failed to synergize with the microtubule-destabilizing agents vinblastine and 2-methoxyestradiol. Peloruside A and laulimalide did, however, synergize with the epothilones, as had been previously shown, but not with docetaxel or discodermolide.

CONCLUSIONS:

Combining two microtubule-targeting agents with different binding sites does not guarantee a synergistic interaction in cells, and additional factors are likely to be involved. This study highlights the importance of preclinical testing of actual combinations of drugs before proceeding into clinical trials.

2001-04-01·Intensive care medicine1区 · 医学

Dexamethasone inhibits stimulation of pulmonary endothelins by proinflammatory cytokines: possible involvement of a nuclear factor κB dependent mechanism

1区 · 医学

Article

作者: Michael Laule ; Gert Baumann ; Cornelia Bartsch ; Thomas Dschietzig ; Christoph Richter ; Karl Stangl ; Gert Pfannenschmidt

OBJECTIVES:

Recent studies have indicated effectiveness of glucocorticoid (GC) treatment in late, fibroproliferative adult respiratory distress syndrome. There is furthermore growing evidence for a role of endothelin-1 (ET-1) in lung fibroproliferation, but the impact of GC on stimulated pulmonary ET-1 is not well defined.

DESIGN AND SETTING:

Prospective study in an experimental laboratory.

SUBJECTS:

Male Wistar rats.

INTERVENTIONS:

Isolated lungs were perfused over 120 min in recirculatory mode in presence of vehicle, interleukin-1 beta (IL-1 beta; 5 ng/ml) plus tumor necrosis factor-alpha (TNF-alpha; 5 ng/ml), dexamethasone (Dx; 1 nmol/l), Dx (10 nmol/l), IL-1 beta plus TNF alpha plus Dx 1, or IL-1 beta plus TNF alpha plus Dx 10 (n = 6 each). Pulmonary artery endothelial cells were stimulated over 30 min using a similar protocol.

MEASUREMENTS AND RESULTS:

Control lungs released 15.2 +/- 0.6 pg/ml big ET-1 and 0.46 +/- 0.06 pg/ml ET-1, and contained 0.73 +/- 0.05 ng/g wet weight (ww) big ET-1 and 3.06 +/- 0.22 ng/g ww ET-1. IL-1 beta plus TNF-alpha increased release of big ET-1 and ET-1, to 220% and 217%, and lung content of peptides, to 236% and 230%. Dx dose-dependently inhibited the cytokine-induced rise in peptide release and lung content and completely suppressed these effects at 10 nmol/l. Electrophoretic mobility shift assays with nuclear extracts of pulmonary artery endothelial cells demonstrated nuclear binding of the transcription factor nuclear factor kappa B in response to IL-1 beta plus TNF-alpha, which was decreased in presence of Dx 1 and Dx 10.

CONCLUSIONS:

GC inhibit the cytokine-induced upregulation of pulmonary vascular and tissue endothelins, possibly via nuclear factor kappa B dependent mechanisms. This finding may reinforce the therapeutic employment of GC in late ARDS.

100 项与 DX-01 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
细菌性阴道炎	临床3期	中国	长沙大地药物研究所（普通合伙）	2014-09-15
细菌性阴道炎	临床3期	中国	福州瀚力生物医学技术有限公司	2014-09-15
滴虫性阴道炎	临床3期	中国	长沙大地药物研究所（普通合伙）	2014-09-15
滴虫性阴道炎	临床3期	中国	福州瀚力生物医学技术有限公司	2014-09-15