Dirucotide(Dirucotide) - 药物靶点：MBP_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Dirucotide (USAN)、Dirucotide Acetate

+ [3]

靶点

MBP

作用机制

MBP调节剂(髓鞘碱性蛋白调节剂)

治疗领域

免疫系统疾病神经系统疾病其他疾病

在研适应症-

非在研适应症

多发性硬化症慢性进行性多发性硬化复发-缓解型多发性硬化+ [1]

原研机构

University of Alberta

在研机构-

非在研机构

Eli Lilly & Co.

Medwell Capital Corp.BioMS Technology US Corp

+ [2]

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C92H141N25O26

InChIKeyRCTCWZRPYFBGLQ-WMCRPSJMSA-N

CAS号152074-97-0

序列信息

Sequence Code 4657725

来源: *****

关联

7

项与 Dirucotide 相关的临床试验

NL-OMON32699 / Completed临床2期

An Open label Follow-On Study to Assess the Ongoing Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis. - MAESTRO-02 (MBP8298-SP-02)

开始日期2008-12-01

申办/合作机构

ICON Clinical Research, Inc.

EUCTR2004-002571-16-GB / Not yet recruitingN/A

A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01

开始日期2007-06-29

申办/合作机构

BioMS Technology Corp.

NCT00468611 / Terminated临床3期

A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)

开始日期2007-06-01

申办/合作机构

BioMS Technology Corp.

100 项与 Dirucotide 相关的临床结果

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100 项与 Dirucotide 相关的转化医学

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100 项与 Dirucotide 相关的专利（医药）

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10

项与 Dirucotide 相关的文献（医药）

2019-10-01·Multiple Sclerosis Journal - Experimental, Translational and Clinical

Machine learning in secondary progressive multiple sclerosis: an improved predictive model for short-term disability progression

Article

作者: Traboulsee, Anthony L ; Tam, Roger ; Li, David KB ; Freedman, Mark S ; Law, Marco TK ; Carruthers, Robert L ; Kolind, Shannon H

Background Enhanced prediction of progression in secondary progressive multiple sclerosis (SPMS) could improve clinical trial design. Machine learning (ML) algorithms are methods for training predictive models with minimal human intervention. Objective To evaluate individual and ensemble model performance built using decision tree (DT)-based algorithms compared to logistic regression (LR) and support vector machines (SVMs) for predicting SPMS disability progression. Methods SPMS participants ( n = 485) enrolled in a 2-year placebo-controlled (negative) trial assessing the efficacy of MBP8298 were classified as progressors if a 6-month sustained increase in Expanded Disability Status Scale (EDSS) (≥1.0 or ≥0.5 for a baseline of ≤5.5 or ≥6.0 respectively) was observed. Variables included EDSS, Multiple Sclerosis Functional Composite component scores, T2 lesion volume, brain parenchymal fraction, disease duration, age, and sex. Area under the receiver operating characteristic curve (AUC) was the primary outcome for model evaluation. Results Three DT-based models had greater AUCs (61.8%, 60.7%, and 60.2%) than independent and ensemble SVM (52.4% and 51.0%) and LR (49.5% and 51.1%). Conclusion SPMS disability progression was best predicted by non-parametric ML. If confirmed, ML could select those with highest progression risk for inclusion in SPMS trial cohorts and reduce the number of low-risk individuals exposed to experimental therapies.

2019-01-01·Multiple Sclerosis Journal - Experimental, Translational and Clinical

Effect of different doses of gadolinium contrast agent on clinical outcomes in MS

Article

作者: Taylor, Carolyn ; Traboulsee, Anthony L ; Tam, Roger ; Kang, Heejun ; Freedman, Mark S ; Ackermans, Nathalie ; Li, David KB ; Carruthers, Robert ; Kolind, Shannon

Objective The objective of this paper is to evaluate potential dose-dependent adverse effects of gadolinium-based contrast agents (GBCAs) on MS progression. Methods Outcomes from a cohort of 612 secondary progressive MS (SPMS) patients, enrolled in a two-year, placebo-controlled (negative) trial assessing the efficacy of MBP8298, were acquired. Patients received one to four (infrequent cohort; IFR) or 5–11 (frequent cohort; FR) GBCA injections between week 4 and week 104. The primary outcome was the change in Expanded Disability Status Scale (EDSS) and time to confirmed EDSS progression. Secondary outcomes included the changes in the Multiple Sclerosis Functional Composite (MSFC), Timed 25-Foot Walk (T25FW), 9-Hole-Peg Test (9HPT), and Paced Auditory Serial Addition Test (PASAT) from baseline to week 104. Results The 512 IFR and 100 FR participants showed no differences in baseline demographics or disease history. The mean change from baseline to week 104 in EDSS was +0.21 (IFR) and +0.13 (FR); MSFC –0.38 (IFR) and –0.14 (FR); T25FW +1.28 (IFR) and +0.55 (FR); 9HPT –0.06 (IFR) and –0.08 (FR); and PASAT +0.22 (IFR) and +0.20 (FR). The FR to IFR progression hazard ratio equaled 0.68 ( p = 0.09). There were no significant differences in any of the outcomes between the two cohorts. Conclusion There were no differences in the disability progression measures between the two cohorts, indicating that gadolinium does not result in greater clinical worsening in SPMS after a two-year period.

2017-09-01·Journal of Chromatography A2区 · 化学

Purification of dirucotide, a synthetic 17-aminoacid peptide, by ion exchange centrifugal partition chromatography

2区 · 化学

Article

作者: Jean-Hugues Renault ; Leslie Boudesocque ; Jean-Marc Nuzillard ; Luciano Forni ; Agathe Martinez ; Matthieu Giraud

Dirucotide is a synthetic drug candidate for the treatment of multiple sclerosis. This 17-aminoacid peptide was successfully purified by ion exchange centrifugal partition chromatography. The optimized conditions involved the biphasic methyl tert-butyl ether/acetonitrile/n-butanol/water (2:1:2:5, v/v) solvent system in the descending mode, the di(2-ethylhexyl)phosphoric acid cation-exchanger with an exchanger (di(2-ethylhexyl)phosphoric acid)/dirucotide mole ratio of 100 and Ca²⁺ ions in aqueous solution as displacer. Critical impurities were efficiently eliminated and dirucotide was recovered in high yield and purity (69% and 98%, respectively) and with a productivity of 2.29g per liter of stationary phase per hour.

100 项与 Dirucotide 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09396	Dirucotide	-	DB04921

研发状态

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
继发进展型多发性硬化	临床3期	西班牙	Eli Lilly & Co.	2004-12-01
继发进展型多发性硬化	临床3期	拉脱维亚	Eli Lilly & Co.	2004-12-01
继发进展型多发性硬化	临床3期	爱沙尼亚	Eli Lilly & Co.	2004-12-01
继发进展型多发性硬化	临床3期	丹麦	Eli Lilly & Co.	2004-12-01
继发进展型多发性硬化	临床3期	德国	Eli Lilly & Co.	2004-12-01
多发性硬化症	临床3期	-	University of Alberta	-
多发性硬化症	临床3期	美国	Medwell Capital Corp.	-
多发性硬化症	临床3期	加拿大	Medwell Capital Corp.	-
多发性硬化症	临床3期	欧盟	Medwell Capital Corp.	-
多发性硬化症	临床3期	-	Autoimmune Technologies LLC	-