Plasminogen(Omnio AB)(Plasminogen(Omnio AB)) - 药物靶点：PLG_在研适应症：糖尿病足，耳部疾病_专利_临床

概要

基本信息

药物类型

酶

别名-

靶点

PLG

作用机制

PLG调节剂(纤溶酶原调节剂)

治疗领域

神经系统疾病心血管疾病内分泌与代谢疾病+ [2]

在研适应症

糖尿病足耳部疾病

非在研适应症-

原研机构

ProMetic Biotherapeutics Ltd.

在研机构

Omnio AB

Liminal BioSciences, Inc.

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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序列信息

Sequence Code 1687

关联

2

项与 Plasminogen(Omnio AB) 相关的临床试验

NCT02690714 / Completed临床2/3期

A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of Prometic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult subjects with hypoplasminogenemia.

开始日期2016-05-04

申办/合作机构

ProMetic Biotherapeutics Ltd.

NCT02312180 / Completed临床1期

A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children With Hypoplasminogenemia

ProMetic is intiitating a first-in-man study entitled "A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children with Hypoplasminogenemia". The general objectives of this clinical study, (Protocol #2002C005G), are to determine the optimal dose and interval required to support the planned Phase 2/3 study and to investigate initial safety and tolerability.

开始日期2014-12-01

申办/合作机构

ProMetic Biotherapeutics Ltd.

100 项与 Plasminogen(Omnio AB) 相关的临床结果

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100 项与 Plasminogen(Omnio AB) 相关的转化医学

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100 项与 Plasminogen(Omnio AB) 相关的专利（医药）

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382

项与 Plasminogen(Omnio AB) 相关的文献（医药）

2024-12-01·Microbial Pathogenesis

Fibrinolytic treatment using recombinant tissue-type plasminogen activator (rt-PA) for staphylococcal infective endocarditis

Article

作者: Fukuda, Kazumasa ; Ishii, Hiromu ; Ogawa, Midori ; Takigawa, Tomoya ; Saito, Mitsumasa ; Miyahara, Satoshi ; Nishimura, Yosuke

Infective endocarditis (IE) is a severe illness characterized by vegetation of bacterial thrombosis. We hypothesized that adding recombinant tissue-type plasminogen activator (rt-PA) to antibiotics would contribute to good results in the treatment of IE. As an in vitro study, we injected labeled Staphylococcus aureus (S. aureus) and either rt-PA or PBS + plasminogen into a polydimethylsiloxane flow chamber with fibrin on a coverslip, and then performed immunofluorescent area assessment. As an in vivo experiment, IE model rats that had suffered mechanical damage in the aortic valve by catheter and revealed bacterial vegetation caused by S. aureus injection were treated with either a control, cefazolin (CEZ), rt-PA, or rt-PA + CEZ, for 7 days. Survival was assessed for 14 days after the appearance of vegetation, with daily monitoring of the vegetation by transthoracic echocardiography (TTE). The in vitro investigation showed that perfusion of rt-PA could detach S. aureus significantly more efficiently than PBS could. In the in vivo research, the rt-PA + CEZ group survived significantly longer than the other groups, and rt-PA + CEZ was more effective than CEZ in the dissolution of vegetation, as observed by TTE. In conclusion, adding rt-PA to antibiotic treatment could dissolve the vegetation component synergistically and improve the survival rate.

2024-08-12·Acta Oto-Laryngologica

Plasminogen - safe for treatment of chronic tympanic membrane perforation: a phase 1 randomized, placebo-controlled study

Article

作者: Tideholm, Bo ; Berglin, Cecilia Engmér ; Sepehri, Elnaz ; Hellström, Sten

BACKGROUNDThere is a need for a simpler and accessible intervention to heal tympanic membrane perforations than myringoplasty that is todaýs golden standard. Experimental studies have identified plasminogen as a promising agent for medical treatment of chronic tympanic membrane perforation.AIMS/OBJECTIVESThis was a phase 1, prospective, randomized, placebo-controlled study with the main objective to evaluate the safety of injecting plasminogen in the vicinity of the tympanic membrane in subjects with chronic tympanic membrane perforation.MATERIAL AND METHODSAdults diagnosed with a dry chronic tympanic membrane perforation were recruited for an injection schedule with Human plasminogen 10. Adverse events, audiometry, VAS fluctuations and size of perforation, were monitored throughout the length of the study.RESULTSIt was possible to perform the injections according to schedule in all subjects. None of the subjects experienced any severe adverse events. Most common adverse event was ear pain. No signs of ototoxicity were reported.CONCLUSIONS AND SIGNIFICANCEThis pilot study suggests that plasminogen injections close to the tympanic membrane as treatment for chronic tympanic membrane injections are safe and feasible, encouraging further dose-escalating studies.

2024-07-01·Advances in Skin & Wound Care

Nonhealing Surgical Wounds in a Patient with Plasminogen Deficiency Type 1 Successfully Treated with Intravenous Plasminogen: A Case Report

Article

作者: Decker, Robert Wayne ; Parker, Joseph Mickler ; Crea, Roberto ; Lorber, Jeremy ; Thibaudeau, Karen

ABSTRACTIntravenous plasminogen replacement therapy for patients with plasminogen deficiency type 1 (hypoplasminogenemia) was recently approved for marketing in the US. In this case report, the authors describe a 33-year-old man with hypoplasminogenemia who developed nonhealing postsurgical wounds following trauma to his right hand despite receiving standard treatment for 4 months. The patient was enrolled in a compassionate-use protocol with intravenous plasminogen replacement therapy and experienced prompt resolution of surgical wounds. He was the first human patient to receive replacement therapy with plasminogen, human-tvmh in the US and first to demonstrate cutaneous wound healing in addition to resolution of ligneous lesions attributable to plasminogen deficiency type 1.

100 项与 Plasminogen(Omnio AB) 相关的药物交易

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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
糖尿病足	临床2期	-	Omnio AB	-
糖尿病足	临床2期	-	Liminal BioSciences, Inc.	-
耳部疾病	临床2期	-	Omnio AB	-
耳部疾病	临床2期	-	Liminal BioSciences, 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


NCT02690714 (CTgov)	临床2/3期	先天性纤溶酶原缺陷症	15	Plasminogen (Human) intravenous	淵齋餘鬱憲鑰製艱願醖(襯網廠鑰齋獵顧遞製鬱) = 鹽鬱餘夢艱願選廠築觸選窪築夢積遞網齋糧簾 (鹽夢襯衊簾憲鹹憲願顧, 齋鹹窪窪鹽網壓鬱構顧 ~ 齋醖鏇網壓膚積築壓糧) 更多	-	2021-04-19