Pegarginase(Bio-Cancer Treatment International Ltd.)(Pegarginase(Bio-Cancer Treatment International Ltd.)) - 药物靶点：Arginine_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

Arginine

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

晚期肝细胞癌淋巴瘤难治性急性髓细胞白血病+ [1]

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-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)终止

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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310

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

2024-07-23·Journal of Bone and Mineral Research

Skeletal consequences of preterm birth in pigs as a model for preterm infants

Article

作者: Adra, Amal ; Rasmussen, Martin B ; Sangild, Per T ; Ko, Frank C ; Moran, Meghan M ; Thymann, Thomas ; Sumner, Dale Rick ; Wilson, Brittany M

AbstractPreterm birth affects about 10% of all live births with many resultant health challenges, including metabolic bone disease of prematurity (MBDP), which is characterized by elevated alkaline phosphatase, suppressed phosphate, and deficient skeletal development. Because of the lack of an animal model, very little is known about bone structure, strength, and quality after preterm birth. This study investigated the utility of a pig model to replicate clinical features of preterm birth, including MBDP, and sought to determine if early postnatal administration of IGF-1 was an effective treatment. Preterm pigs, born by caesarean section at 90% gestation, were reared in intensive care facilities (respiratory, thermoregulatory, and nutritional support) and compared with sow-reared term pigs born vaginally. Preterm pigs were systemically treated with vehicle or IGF-1 (recombinant human IGF-1/BP-3, 2.25 mg/kg/d). Tissues were collected at postnatal days 1, 5, and 19 (the normal weaning period in pigs). Most bone-related outcomes were affected by preterm birth throughout the study period, whereas IGF-1 supplementation had almost no effect. By day 19, alkaline phosphatase was elevated, phosphate and calcium were reduced, and the bone resorption marker C-terminal crosslinks of type I collagen was elevated in preterm pigs compared to term pigs. Preterm pigs also had decrements in femoral cortical cross-sectional properties, consistent with reduced whole-bone strength. Thus, the preterm pig model replicates many features of preterm bone development in infants, including features of MBDP, and allows for direct interrogation of skeletal tissues, enhancing the field’s ability to examine underlying mechanisms.

2024-05-01·British Journal of Pharmacology

Intravenous recombinant cerebellin 1 treatment restores signalling by spinal glutamate delta 1 receptors and mitigates chronic pain

Article

作者: Chettiar, Poojashree B ; Dravid, Shashank M ; Thakur, Shriti S ; S Narasimhan, Kishore Kumar ; Asati, Devansh G ; Gakare, Sukanya G ; Shelkar, Gajanan P ; Sabnis, Siddhesh S

Background and PurposeChronic pain remains a major clinical problem that needs effective therapeutic agents. Glutamate delta 1 (GluD1) receptors and the protein cerebellin 1 (Cbln1) are down‐regulated in the central amygdala (CeA) in models of inflammatory and neuropathic pain. One treatment with Cbln1, intracerebroventricularly (ICV) or in CeA, normalized GluD1 and reduced AMPA receptor expression, resulting in lasting (7–10 days) pain relief. Unlike many CNS‐targeting biological agents, the structure of Cbln1 suggests potential blood–brain barrier penetration. Here, we have tested whether systemic administration of Cbln1 provides analgesic effects via action in the CNS.Experimental ApproachAnalgesic effects of intravenous recombinant Cbln1 was assessed in complete Freund's adjuvant inflammatory pain model in mice. GluD1 knockout and a mutant form of Cbln1 were used.Key ResultsA single intravenous injection of Cbln1 mitigated nocifensive and averse behaviour in both inflammatory and neuropathic pain models. This effect of Cbln1 was dependent on GluD1 receptors and required binding to the amino terminal domain of GluD1. Time course of analgesic effect was similar to previously reported ICV and intra‐CeA injection. GluD1 in both spinal cord and CeA was down –regulated in the inflammatory pain model, whereas GluD1 expression in spinal cord but not in CeA, was partly normalized by intravenous Cbln1. Importantly, recombinant Cbln1 was detected in the synaptoneurosomes in spinal cord but not in the CeA.Conclusions and ImplicationsOur results describe a novel mechanism by which systemic Cbln1 induces analgesia potentially by central actions involving normalization of signalling by spinal cord GluD1 receptors.

2024-05-01·Pediatric Research

Gut development following insulin-like growth factor-1 supplementation to preterm pigs

Article

作者: Bæk, Ole ; Burrin, Douglas G ; Thymann, Thomas ; Pankratova, Stanislava ; Rasmussen, Martin Bo ; Sangild, Per Torp ; Holgersen, Kristine

AbstractBackgroundReduced insulin-like growth factor-1 (IGF-1) levels may contribute to impaired organ development in preterm infants. Using preterm pigs as a model, we hypothesized that IGF-1 supplementation improves health and gut development during the first three weeks of life.MethodsFirst, clinical and organ endpoints were compared between artificially-reared, cesarean-delivered preterm pigs and vaginally-delivered, sow-reared term pigs at 5, 9 and 19 days. Next, preterm pigs were treated with recombinant human IGF-1 for 19 days (2.25 mg/kg/day, systemically).ResultsRelative to term pigs, preterm pigs had lower body weight, fat, bone contents, relative weights of liver and spleen and a longer and thinner intestine at 19 days. Preterm birth reduced intestinal villi heights and peptidase activities, but only at 5 and 9 days. In preterm pigs, IGF-1 reduced mortality primarily occurring from gastrointestinal complications and with a tendency towards salvaging smaller pigs. IGF-1 supplementation also increased spleen and kidney weights, small intestine length and maltase to lactase activity, reflecting gut maturation.ConclusionPreterm birth affects body composition and gut maturation in the first 1–2 weeks, but differences are marginal thereafter. Supplemental IGF-1 may improve gut health in pigs and infants in the first few weeks after preterm birth.Impact

Insulin-like growth factor 1 (IGF-1) supplementation may improve gut health and development in prematurity, but whether the effects are sustained beyond the immediate postnatal period is unclear.

In preterm pigs, the prematurity effects on IGF-1 and gut health deficiencies are most pronounced during the first week of life and diminishes thereafter.

In preterm pigs, IGF-1 supplementation beyond the first week of life reduced mortality.

The present study provides evidence of a sustained effect of IGF-1 supplementation on the gastrointestinal tract after the immediate postnatal period.

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
白血病	临床2期	中国	康达医药科技有限公司	2012-04-01
淋巴瘤	临床2期	中国	康达医药科技有限公司	2012-04-01
难治性急性髓细胞白血病	临床1期	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	临床1期	中国香港	康达医药科技有限公司	2016-09-01
晚期肝细胞癌	临床1期	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	(夢憲蓋襯膚憲顧餘鑰衊) = 選積襯鹽憲壓窪艱糧夢衊壓鹹夢糧膚壓構醖選 (廠積願夢蓋艱廠製簾積, 5.9 ~ 6.0) 更多	积极	2021-10-01
WCLC2016	N/A	恶性胸膜间皮瘤	-	BCT-100	製獵簾艱壓憲鏇壓廠齋(製獵鹽製憲製鏇簾鹹鏇) = 襯艱齋夢膚艱壓蓋鬱鏇衊鏇遞廠鏇鏇襯壓廠憲 (糧廠餘鹹夢築淵繭醖蓋 )	-	2016-12-07
ASCO2010	临床1期	晚期肝细胞癌	15	Recombinant human arginase I (rhArgI)	簾繭窪顧鑰繭醖鑰醖鏇(餘築遞糧壓鬱簾積廠範) = DLT was Gr 3 prolonged elevation of bilirubin in 2 patients at 2500 U/kg 網築選獵遞鏇夢範築觸 (繭壓淵鬱顧遞淵壓築憲 ) 更多	-	2010-05-20