A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH. Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period.

开始日期2019-03-18

申办/合作机构

Stanford University

[+3]

EUCTR2010-019527-58-GB / Not yet recruiting临床2期

EMPIRE-Elafin Myocardial Protection from Ischaemia RepErfusion injury - Effect of elafin on myocardial injury

开始日期2011-05-24

申办/合作机构

NHS Lothian

[+1]

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项与 Tiprelestat(Proteo Biotech AG) 相关的文献（医药）

2024-12-31·Hematology (Amsterdam, Netherlands)

Diagnostic and prognostic role of elafin in skin acute graft versus host disease: a systematic review

Review

作者: Abu Serhan, Hashem ; Bhandari, Pragya ; Neupane, Raksha ; Yadav, Rukesh ; Sah, Ranjit ; Barboza, Joshuan J ; Paudel, Sunil ; Sah, Sanjit ; Shah, Sangam ; Bhattarai, Abhinav ; Dhakal, Garima

BACKGROUND AND OBJECTIVE:

Graft versus host disease (GVHD) is the common complication seen after allogeneic hematopoietic stem cell transplantation (HSCT) and a pleomorphic syndrome that resembles autoimmune and other immunologic disorders, leading to profound immune dysregulation and organ dysfunction. The most common targets of GVHD are skin, gastrointestinal tract and liver. GVHD is classified as acute graft versus host disease (aGvHD) if it occurs within the first 100 days after HSCT and chronic graft versus host disease(cGVHD) if it occurs after day 100. The skin is most frequently and earliest affected by aGvHD, followed by the gastrointestinal tract and liver. An ideal biomarker would predict the onset and severity of clinical acute GVHD and help to direct management, and this is an area of active research regarding the use of biomarkers for diagnosis and prognosis of acute GVHD. Recently, elafin has been identified as a potential plasma biomarker for aGVHD.

METHOD:

We searched the databases PubMed, Cochrane library, and medRxiv for all studies investigating the Diagnostic or prognostic role of elafin in GVHD. We set the search strategy incorporating the search terms, 'elafin', 'graft versus host', and 'GVHD', and operated using the Boolean operators 'AND', and 'OR'. Thus, retrieved articles were then exported on an Excel® sheet, and duplicates were removed. The systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. After selecting the study based on inclusion criteria, data on study characteristics and biomarker description was extracted on a pre-determined data extraction table on the Microsoft Excel version. The quality assessment of the included studies was determined using the QUIPS tool.

RESULT:

The search revealed 547 studies and 6 studies that met the eligibility criteria of this review have been included. The major finding of our study is the significant elevation of elafin in skin aGVHD.

CONCLUSION:

Elafin is a significant biomarker for diagnosis and prognosis of skin aGVHD and should be assessed within 2 weeks of the onset of the disease.

Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES

Effect of ischemia-reperfusion injury on elafin levels in rat liver

Article

作者: Aslaner, Arif ; Özgül, Halit ; Yıldırım, Senay ; Yılmaz, Abdullah Hilmi ; Dogan, Ugur ; Ellidag, Hamit Yasar ; Uzmay, Yunus

BACKGROUND:

The aim of this study was to quantify serum levels of elafin, a serine protease inhibitor, and to assess its effects on histopathological and biochemical parameters in hepatic ischemia-reperfusion injury.

METHODS:

Forty female Wistar albino rats were divided into five groups: Group 1 served as the control group. Liver ischemia was induced for 30 minutes in the other four groups. An additional 1-hour, 2-hour, and 3-hour reperfusion was induced in Groups 3, 4, and 5, respectively. At the end of the experiment, intracardiac blood samples were obtained for biochemical examination, and tissue samples from the liver were taken for histopathological examination. Levels of elafin, ischemia-modified albumin (IMA), total antioxi-dant status (TAS), and total oxidant status (TOS) were also examined.

RESULTS:

Serum elafin levels decreased beginning from Group 2, with the lowest level reached in Group 5 (p<0.01). The IMA level was the lowest in the control group and the highest in Group 5 (p<0.01). TOS, aspartate aminotransferase (AST), and alanine amino-transferase (ALT) levels were lowest in the control group and highest in Group 5 (p<0.01). Group 5 had the highest IMA/albumin ratio, although no significant differences were found between these four groups. The lowest TAS level was found in the control group, but a stable and significant increase was not detected in the other groups. No significant differences were found between the groups in terms of alkaline phosphatase (ALP) and albumin levels. A negative correlation was observed between serum elafin levels and AST, ALT, and TOS levels (p<0.01). The number of Grade 1 histopathological results was found to be higher in the groups with reperfusion (Groups 3, 4, 5). In histopathological subgroup analysis, while the elafin level was lower in Grade 1 group, AST, ALT, and TOS levels were higher (p<0.01). Additionally, the IMA/albumin ratio was found to be higher in the Grade 1 group (p=0.02).

CONCLUSION:

In hepatic ischemia-reperfusion injury, elafin levels decreased as the reperfusion time increased. As the reperfusion time increased, both hepatocyte damage and oxidant capacity increased, with a negative correlation observed between these findings and elafin levels. Therefore, elafin may play a protective role in hepatic ischemia-reperfusion injury and could assist clinicians in assessing liver injury.

2023-07-27·Cancers

Elafin as a Prognostic Marker in Esophageal Squamous Cell Carcinoma: A Pilot Study Using Three-Dimensional Imaging and Genomic Profiling.

Article

作者: Wu, Chun-Chieh ; Wang, Yao-Kuang ; Zhuo, Guan-Yu ; Chen, Chu-Chih ; Chen, Wei-Chung ; Wu, Ming-Tsang ; Liu, Yu-Peng ; Wang, Yin-Han ; Chen, Yi-Hsun ; Wu, I-Chen

Esophageal cancers are globally the sixth deadliest malignancy, with limited curative options. The association of high serum elafin levels, a molecule produced by epithelial cells, with esophageal squamous cell carcinoma (ESCC) risk is established, but its link to poor ESCC prognosis remains unclear. To explore this question, we first used three-dimensional confocal imaging to create a model of the spatial distribution of elafin inside locoregional ESCC tissues. Then, after analyzing data obtained from whole-genome microarrays for ESCC cell lines and their more invasive sublines, we performed in vitro experiments using RNA sequencing to identify possible elafin-related pathways. Three-dimensional tissue imaging showed elafin distributed as an interweaved-like fibrous structure in the stroma of tissue obtained from patients with high serum levels of elafin and poorer prognoses. By contrast, the signal was confined inside or around the tumor nest in patients who had lower serum levels and better survival. The analysis of a TCGA dataset revealed that higher levels of elafin mRNA in stage I-IIIA ESCC patients were associated with shorter survival. The in vitro studies revealed that elafin promoted ESCC cell proliferation, migration, and invasion via the epithelial-mesenchymal transition pathway. Thus, elafin inhibition could potentially be used therapeutically to improve survival in patients with locoregional ESCC.

项与 Tiprelestat(Proteo Biotech AG) 相关的新闻（医药）

2023-05-16

·BioSpace

tiakis Biotech AG and Northway Biotech: Successful Tech Transfer and Expansion of Manufacturing Capabilities for Tiprelestat

KIEL, GERMANY / ACCESSWIRE / May 16, 2023 / tiakis Biotech AG (tiakis), in collaboration with its CDMO partner Northway Biotech, is pleased to announce the successful completion of a technology transfer and ramp-up of manufacturing capabilities for Tiprelestat, a pioneering anti-inflammatory and tissue-protective drug being developed for the prevention of postoperative inflammatory complications following major surgery, treatment of COVID-19 and pulmonary arterial hypertension. For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L. tiakis Biotech AG and Northway Biotech collaboration tiakis Biotech AG and Northway Biotech: Successful Tech Transfer and Expansion of Manufacturing Capabilities for Tiprelestat "The marked increase in manufacturing capabilities lays the foundation for the next stage of tiakis' development programs, with the recent start of our COMCOVID phase Ib/II clinical trial being a prime example," said Martin Voss, tiakis Biotech AG co-CEO. The enhanced production capabilities is a result of the successful completion of a technology transfer and subsequent ramp-up program, achieved in a short time through close collaboration with end-to-end biologics CDMO Northway Biotech, based in Vilnius, Lithuania. Reflecting on this milestone, Vladas Algirdas Bumelis, CEO of Northway Biotech, stated: "The confidence our partners have placed in our two-decade-long expertise has enabled us to collaboratively scale up the process and meet tiakis' deadlines. Our state-of-the-art 3,000 L stainless-steel fermenter train was utilized to carry out the implementation successfully. We extend our sincere well-wishes to our partners as they move forward with their innovative drug through clinical trials, and we look forward to future collaborations." André Markmann, VP Business Development of Northway Biotech, added: "This partnership exemplifies our commitment to assist our partners in achieving their objectives by leveraging our technical expertise and operational capabilities. We are immensely proud to be part of this groundbreaking project, which addresses a significant unmet medical need." By attaining this pharmaceutical and technological milestone, tiakis and Northway Biotech have demonstrated their capabilities to pave the way towards groundbreaking achievements as pioneers in their respective fields. The success of this fast-paced project is characterized by strong collaborative interaction, mutual trust, and flexibility between the two companies. About Tiprelestat tiakis biopharmaceutical drug candidate Tiprelestat promises an excellent therapeutic benefit-risk pro use as an anti-inflammatory and tissue-protective drug. Tiprelestat is identical to the human protein elafin with high specificity for tissue-destroying and inflammation-promoting proteases. The development program of Tiprelestat is focused on the late-stage development of Tiprelestat in major surgery and early-stage development in pulmonary arterial hypertension (PAH) and COVID-19. About tiakis Biotech AG tiakis focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Tiprelestat for life-threatening surgeries and life-threatening diseases such as PAH and COVID-19. tiakis seeks partners and investors for the development, commercial-scale manufacturing, marketing and distribution of the product. The company tiakis Biotech AG is located in Kiel, Germany ( ). About Northway Biotech Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US. Further information can be found on Northway's website . Contact Information Vladas Bumelis CEO and Chairman of the Board vladas.bumelis@northwaybiotech.com SOURCE: Northway Biotech View source version on accesswire.com:

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KEGG	Wiki	ATC	Drug Bank
-	Tiprelestat(Proteo Biotech AG)	-	DB05161

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
心肌再灌注损伤	临床2期	英国	tiakis BIOTECH AG	2011-07-28
术后炎症	临床2期	德国	tiakis BIOTECH AG	2008-10-27
肺动脉高压	临床1期	美国	-	2019-02-23
肺移植排斥反应	临床前	美国	Stanford University	-

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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


WCD2023	N/A	急性移植物抗宿主病	-	elafin (GVHD)	壓獵製壓艱範窪膚顧膚(蓋鬱齋鑰範醖網鑰衊顧) = 鏇衊積齋觸糧繭遞醖鬱壓鏇鏇鏇齋積憲淵製糧 (壓構鏇淵糧醖範醖鑰願 )	-	2023-07-03
				elafin (non-GVHD rash)	網鹽鹽構淵簾餘鏇壓憲(獵簾網齋鏇糧鏇鬱膚憲) = 選膚範積襯蓋鹹蓋鹹顧膚夢構鹽選築網醖衊選 (夢壓餘夢壓壓襯構衊衊 )