Pegarginase(Bio-Cancer Treatment International Ltd.)(Pegarginase(Bio-Cancer Treatment International Ltd.)) - 药物靶点：ARG_在研适应症：急性髓性白血病_专利_临床

概要

基本信息

药物类型

酶

别名

PEG-arginase、PEGylated recombinant human arginase、Pegarginase

+ [4]

靶点

ARG

作用方式-

作用机制

精氨酸酶替代物

治疗领域

肿瘤血液及淋巴系统疾病

在研适应症

急性髓性白血病

非在研适应症

前列腺腺癌晚期肝细胞癌晚期恶性实体瘤+ [4]

原研机构

康达医药科技有限公司

在研机构

康达医药科技有限公司

非在研机构

Oncotherapeutics, Inc.

权益机构

天境生物技术（天津）有限公司

康达医药科技有限公司

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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关联

7

项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 相关的临床试验

NCT03455140

/ Completed临床1/2期IIT

A Phase I/II Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) in Relapsed/Refractory Cancers of Children and Young Adults

PARC is an international phase I/II trial evaluating the safety and activity of pegylated recombinant human arginase (BCT-100) in children and young people with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).
Currently the outcomes for these patients are poor and the therapeutic options are limited with a significant toxicity burden. Therefore new treatments which work in different ways to standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults and shown to be active with almost no side-effects. This trial will test whether this dose of BCT-100 is also safe and active in children with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken down in the body and look for new biological markers of treatment response. Up to 64 children with relapsed cancers will be recruited over 2 years.

开始日期2018-08-28

申办/合作机构

University of Birmingham

NCT02899286

/ Unknown status临床2期

A Phase II Open-label Study of the Efficacy and Safety of Recombinant Human Arginase 1 (PEG-BCT-100) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid leukemia (AML) in terms of remission rate.

开始日期2016-09-01

申办/合作机构

康达医药科技有限公司

NCT02285101

/ Completed临床1期

Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors: Dose Escalation, Safety and PK/PD

The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as an infusion to treat patients who bear advanced solid tumors that are dependent on arginine (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have progressed after receiving approved or established therapies. This is a Phase 1 study; PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.

开始日期2014-11-01

申办/合作机构

康达医药科技有限公司

[+1]

100 项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 相关的临床结果

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100 项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 相关的转化医学

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100 项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 相关的专利（医药）

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29

项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 相关的文献（医药）

2023-10-09·EMBO reports

Arginine dependency is a therapeutically exploitable vulnerability in chronic myeloid leukaemic stem cells

Article

作者: Prasad, Bodhayan ; Tardito, Saverio ; Mussai, Francis ; Vande Voorde, Johan ; Rattigan, Kevin M ; Zerbst, Désirée ; Brabcova, Zuzana ; Kalkman, Eric R ; Helgason, G Vignir ; Dunn, Karen ; Scott, Mary T ; Ianniciello, Angela ; Zarou, Martha M ; Shokry, Engy ; Copland, Mhairi ; Cheng, Paul ; Sumpton, David ; Sarnello, Daniele

AbstractTo fuel accelerated proliferation, leukaemic cells undergo metabolic deregulation, which can result in specific nutrient dependencies. Here, we perform an amino acid drop‐out screen and apply pre‐clinical models of chronic phase chronic myeloid leukaemia (CML) to identify arginine as a nutrient essential for primary human CML cells. Analysis of the Microarray Innovations in Leukaemia (MILE) dataset uncovers reduced ASS1 levels in CML compared to most other leukaemia types. Stable isotope tracing reveals repressed activity of all urea cycle enzymes in patient‐derived CML CD34+ cells, rendering them arginine auxotrophic. Thus, arginine deprivation completely blocks proliferation of CML CD34+ cells and induces significantly higher levels of apoptosis when compared to arginine‐deprived cell lines. Similarly, primary CML cells, but not normal CD34+ samples, are particularly sensitive to treatment with the arginine‐depleting enzyme, BCT‐100, which induces apoptosis and reduces clonogenicity. Moreover, BCT‐100 is highly efficacious in a patient‐derived xenograft model, causing > 90% reduction in the number of human leukaemic stem cells (LSCs). These findings indicate arginine depletion to be a promising and novel strategy to eradicate therapy resistant LSCs.

2023-10-01·European Journal of Pharmacology

Intranasal EP4 agonist and arginase-1 therapy in a murine model of asthma

Article

作者: Gercke, Philipp ; Lautenschlager, Nikoleta ; Vedder, Nora ; Kolahian, Saeed ; van Geffen, Chiel ; Renz, Harald

Research findings evermore suggest a crucial role of myeloid-derived suppressor cells (MDSCs) in chronic lung diseases including asthma. Previously, we showed that intravenous (IV) treatment with a prostaglandin E2 receptor 4 (EP4) agonist, L-902,688, promoted MDSC suppressive activity. IV therapy with L-902,688 and BCT-100, a human pegylated arginase-1, ameliorated lung inflammatory features in a murine model of asthma. Here, we further investigate the potential therapeutic approach by studying the local therapy effects on the lungs after intranasal (IN) application. Using a two-week model of house dust mite (HDM)-induced murine asthma, the effect of IN treatment with L-902,688 or BCT-100 on in vivo lung function, inflammatory features of asthma and MDSC generation and activation was studied. Our experiments demonstrated increased suppressive activity of pulmonary MDSCs after induction of allergic airway disease. IN treatment with L-902,688 and BCT-100 further enhanced the immunosuppressive activity of pulmonary MDSCs. Additionally, treatment with BCT-100 reduced pulmonary T cell numbers. Asthmatic mice that received IN L-902,688 showed improved in vivo lung function. In conclusion, our results underline the potential of modulating MDSCs systemically or locally as a future therapeutic option in airway inflammatory diseases such as asthma.

2022-10-01·3 Biotech

Human arginase 1, a Jack of all trades?

Review

作者: Anakha, J ; Pande, Abhay H ; Jawalekar, Snehal Sainath ; Kawathe, Priyanka S ; Datta, Sayantap ; Banerjee, Uttam Chand

Arginine, a conditionally essential amino acid, plays a crucial role in several metabolic and signalling pathways. Arginine metabolism in the body can be significantly increased under stress or during certain pathological conditions. Depletion of circulating arginine by administering arginine-hydrolysing enzyme has been shown to mitigate varied pathophysiological conditions ranging from cancer, inflammatory conditions, and microbial infection. This review provides an overview of such intriguing expanse of potential applications of recombinant human arginase 1 for different pathological conditions and its status of development.

100 项与 Pegarginase(Bio-Cancer Treatment International Ltd.) 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
急性髓性白血病	临床2期	英国	康达医药科技有限公司	2022-08-10
难治性急性髓细胞白血病	药物发现	中国香港	康达医药科技有限公司	2016-09-01
复发性急性髓细胞白血病	药物发现	中国香港	康达医药科技有限公司	2016-09-01
前列腺腺癌	药物发现	美国	康达医药科技有限公司	2014-11-01
前列腺腺癌	药物发现	美国	Oncotherapeutics, Inc.	2014-11-01
晚期恶性实体瘤	药物发现	美国	Oncotherapeutics, Inc.	2014-11-01
黑色素瘤	药物发现	美国	Oncotherapeutics, Inc.	2014-11-01
黑色素瘤	药物发现	美国	康达医药科技有限公司	2014-11-01
晚期肝细胞癌	药物发现	中国香港	康达医药科技有限公司	2014-04-01
转移性肝细胞癌	药物发现	中国香港	康达医药科技有限公司	2014-04-01

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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


NCT01092091 (BCT-100-002, Pubmed \| Invest New Drugs) 人工标引	临床2期	肝细胞癌 ASS Negative	27	PEG-BCT-100	(窪廠鑰鹹衊膚鹹鏇膚夢) = 鏇築選餘鏇窪鬱範願蓋壓醖獵觸簾選簾構獵壓 (艱願糧膚壓構窪範獵窪, 5.9 ~ 6.0) 更多	积极	2021-10-01
WCLC2016	N/A	恶性胸膜间皮瘤	-	BCT-100	積網鑰鑰膚艱蓋廠顧膚(艱襯繭構廠築鏇繭顧築) = 鏇繭簾襯觸衊積膚網積製鹽願鏇窪艱構壓繭觸 (製餘餘繭淵襯繭衊醖壓 )	-	2016-12-07
SNO2015	N/A	胶质瘤 ASS1 \| ASL \| OTC	5	PEG-BCT-100 (rhArg1peg5000)	積鹹範簾膚製鹹鑰積構(鏇網顧遞選鬱襯觸淵簾) = 餘憲衊膚鹹鑰鏇鹽範鬱鑰觸範鑰鑰製蓋醖遞艱 (鑰壓觸願顧窪製願鹹願 )	-	2015-11-09
SNO2015	N/A	胶质瘤 ASS1 \| ASL \| OTC	5	PEG-BCT-100 (Control (full culture medium))	積鹹範簾膚製鹹鑰積構(鏇網顧遞選鬱襯觸淵簾) = 餘鬱膚鑰繭夢遞膚鹽蓋鑰觸範鑰鑰製蓋醖遞艱 (鑰壓觸願顧窪製願鹹願 )	-	2015-11-09
ASCO2010	临床1期	晚期肝细胞癌	15	Recombinant human arginase I (rhArgI)	鹽構願觸糧糧鏇願衊窪(構獵簾餘築淵淵獵淵鏇) = DLT was Gr 3 prolonged elevation of bilirubin in 2 patients at 2500 U/kg 鬱淵糧窪鹽遞構壓範顧 (遞築網願網願製糧製鬱 ) 更多	-	2010-05-20