Plovamer acetate(Plovamer acetate) - 药物靶点：HLA class II抗原_在研适应症：复发-缓解型多发性硬化_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Plovamer、Plovamer acetate (USAN)

+ [1]

靶点

HLA class II抗原

作用机制

HLA class II抗原调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床2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C27H43N5O9

InChIKeyBBFYAJHFKUFNCR-GPOOOTPOSA-N

CAS号507277-44-3

序列信息

Sequence Code 1058236825

来源: *****

关联

3

项与 Plovamer acetate 相关的临床试验

NCT01963611 / Terminated临床2期

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

开始日期2013-10-01

申办/合作机构

EMD Serono, Inc.

EUCTR2009-012716-40-SK / Not yet recruiting临床2期

The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial

开始日期2010-02-03

申办/合作机构

Peptimmune, Inc.

EUCTR2007-007759-15-HU / Not yet recruitingN/A

The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial

开始日期2008-11-10

申办/合作机构

Peptimmune, Inc.

100 项与 Plovamer acetate 相关的临床结果

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100 项与 Plovamer acetate 相关的转化医学

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100 项与 Plovamer acetate 相关的专利（医药）

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2

项与 Plovamer acetate 相关的文献（医药）

2011-05-01·The Journal of Clinical Pharmacology3区 · 医学

Safety, Pharmacokinetic, and Pharmacodynamic Evaluations of PI-2301, a Potent Immunomodulator, in a First-in-Human, Single-Ascending-Dose Study in Healthy Volunteers

3区 · 医学

Article

作者: Allyson Masci ; Claire Toutin ; Eric Lacoste ; Tony Avril ; Joseph Kovalchin ; Jeffrey Krieger ; Edward Mascioli ; Uday Patel ; Michelle Genova ; Gwenola Gandon ; Alain Patat ; Michael Augustyniak ; Eric Zanelli ; Kathy Collins ; Nicolas Fauchoux

PI-2301 is an amino acid copolymer acting as an immunomodulator for the treatment of autoimmune diseases. The present study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics of PI-2301 in a single ascending dose, first-in-human study involving healthy, male adult volunteers. A total of 56 subjects were given a subcutaneous injection of PI-2301 ranging from 0.035 to 60 mg. The only consistent side effect was transient injection site reactions. We describe, for the first time, a pharmacokinetic assay to monitor amino acid copolymer concentration in human serum. PI-2301 was detected in the serum of subjects in the 10-, 30-, and 60-mg cohorts. Maximum serum concentration was achieved between 10 and 30 minutes postdosing with some compound detected 4 hours after dosing. PI-2301's lasting immunological properties were evident by an ex vivo recall assay showing T-cell proliferation and IL-13 production in subjects dosed with 1, 3, or 10 mg of PI-2301, up to 6 months after dosing. A transient increase in chemokine CXCL9 and CXCL10 plasma levels was seen in subjects dosed with 30 or 60 mg of PI-2301. These results are highly consistent with our preclinical findings and suggest that PI-2301 could facilitate the expansion of a favorable immune posture in patients with autoimmune disorders.

2010-08-25·Journal of Neuroimmunology3区 · 医学

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response☆

3区 · 医学

Article

作者: C. Braudeau ; E. Zanelli ; M. Genova ; M. Augustyniak ; G. Edan ; J. Krieger ; U. Patel ; T. Hittinger ; J. Kovalchin ; E. Mascioli ; B. Kuca ; K. Collins ; M. Rimbert ; A. Masci

PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS. Treatment was given subcutaneously once weekly for 8 weeks, followed by a 4-week open-label treatment period with active drug. The most common adverse event was transient injection site reactions. Non-significant trend for increases in serum levels of IL-3, IL-13, and CCL22 over time were suggestive of a beneficial T(H)2 immune response in subjects dosed with PI-2301 at 3 and 10 mg. MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301.

1

项与 Plovamer acetate 相关的新闻（医药）

2009-08-25

·BioSpace

Peptimmune, Inc. Completes Phase Ib Study of PI-2301 in Multiple Sclerosis Patients, and Presentation at ECTRIMS 2009

CAMBRIDGE, Mass., Aug. 25 /PRNewswire/ -- Peptimmune, Inc., a privately held biotechnology company, announced the completion of a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

100 项与 Plovamer acetate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09657	-	-	-

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
复发-缓解型多发性硬化	临床2期	法国	Peptimmune, Inc.	2010-02-03
葡萄膜炎	临床1期	美国	Peptimmune, Inc.	-
克罗恩病	临床前	美国	Peptimmune, Inc.	-
类风湿关节炎	临床前	美国	Peptimmune, Inc.	-

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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


NCT01963611 (CTgov)	临床2期	复发-缓解型多发性硬化	255	Plovamer acetate 0.5 milligram (mg) (Plovamer Acetate 0.5 Milligram (mg))	餘簾鹹鏇衊製積壓膚繭(獵衊醖簾窪築鑰繭襯憲) = 鏇構鬱顧壓構鹽膚願網淵觸窪顧鏇餘鬱糧蓋鏇 (鏇鹽鏇製襯壓觸範醖糧, 鏇獵醖壓築壓齋構製觸 ~ 簾觸窪願襯顧窪鹽艱築) 更多	-	2016-05-11
				Plovamer acetate 3 mg (Plovamer Acetate 3 mg)	餘簾鹹鏇衊製積壓膚繭(獵衊醖簾窪築鑰繭襯憲) = 蓋鏇積憲繭築衊顧願築淵觸窪顧鏇餘鬱糧蓋鏇 (鏇鹽鏇製襯壓觸範醖糧, 築襯窪鏇鑰選壓範鹹艱 ~ 廠淵鹽獵憲觸鬱鹽顧鬱) 更多