磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical)(PC-SOD)

概要

基本信息

药物类型

酶

别名

CY

靶点

SOD1

作用方式

调节剂

作用机制

SOD1调节剂(超氧化物歧化酶调节剂)

治疗领域

心血管疾病其他疾病

在研适应症-

非在研适应症

心肌梗塞心肌再灌注损伤

原研机构

北京泰德制药股份有限公司

在研机构-

非在研机构

北京泰德制药股份有限公司

权益机构-

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

6

项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 相关的临床试验

JPRN-jRCT2031210466

/ Completed临床2期IIT

Placebo-controlled, double-blind, randomized phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy

开始日期2022-01-19

申办/合作机构-

NCT03995732

/ Unknown status临床2期

Efficacy and Safety Evaluation of Phosphatidyl Choline Cu/Zn Superoxide Dismutase (PC-SOD) for Injection in Reducing Myocardial Reperfusion Injury: a Multicenter, Randomized, Single-blind, Placebo-controlled Dose-finding Study

The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.

开始日期2019-06-18

申办/合作机构

北京泰德制药股份有限公司

[+1]

CTR20160765

/ Completed临床1期

CY单中心、随机双盲、安慰剂平行对照、剂量递增单次静脉给药健康志愿者耐受性及药代动力学临床试验

评价CY在健康成年志愿者中，单次静脉推注给药的耐受性和药代动力学行为。

开始日期2016-12-19

申办/合作机构

北京泰德制药股份有限公司

100 项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 相关的临床结果

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100 项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 相关的转化医学

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100 项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 相关的专利（医药）

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42

项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 相关的文献（医药）

2022-01-01·Life sciences3区 · 医学

Novel pharmacological effects of lecithinized superoxide dismutase on ischemia/reperfusion injury in the kidneys of mice

3区 · 医学

Article

作者: Shimoda, Mikako ; Kubota, Maho ; Tanaka, Ken-Ichiro ; Takafuji, Ayaka ; Kawahara, Masahiro ; Mizushima, Tohru

Renal ischemia/reperfusion (I/R) injury is a major clinical problem because it can cause acute kidney injury (AKI) or lead to the transition from AKI to chronic kidney disease (CKD). Oxidative stress, which involves the production of reactive oxygen species (ROS), plays an important role in the development and exacerbation of I/R-induced kidney injury. However, we have previously reported that lecithinized superoxide dismutase (PC-SOD), a SOD derivative with high tissue affinity and high stability in plasma, has beneficial effects in various disease models because of its inhibitory effect on ROS production. Therefore, we aimed to determine the effects of intravenous PC-SOD administration in a mouse model of renal injury induced by I/R. PC-SOD markedly ameliorated the I/R-induced increases in markers of renal damage (urea nitrogen, creatinine, neutrophil gelatinase-associated lipocalin, and interleukin-6) and tubular necrosis 48 h after the intervention. We also found that PC-SOD significantly ameliorated the I/R-induced increase in ROS production, using an ex vivo imaging system. Furthermore, PC-SOD inhibited the increases in expression of markers of fibrosis (α-smooth muscle actin and collagen 1A1) 96 h after, and renal fibrosis 25 days after I/R was induced. Finally, we found that PC-SOD ameliorated the I/R-induced AKI in mice with high-fat diet-induced prediabetes. These results suggest that PC-SOD inhibits AKI and the transition from AKI to CKD through the inhibition of ROS production. Therefore, we believe that PC-SOD may represent an effective therapeutic agent for I/R-induced renal injury.

2021-09-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie2区 · 医学

Lecithinized superoxide dismutase in the past and in the present: Any role in the actual pandemia of COVID-19?

2区 · 医学

Review

作者: Capozza, Manuela ; Panza, Raffaella ; Laforgia, Nicola ; Farella, Ilaria

The Coronavirus disease 19 (Covid-19) pandemic is devastating the public health: it is urgent to find a viable therapy to reduce the multiorgan damage of the disease. A validated therapeutic protocol is still missing. The most severe forms of the disease are related to an exaggerated inflammatory response. The pivotal role of reactive oxygen species (ROS) in the amplification of inflammation makes the antioxidants a potential therapy, but clinical trials are needed. The lecitinized superoxide dismutase (PC-SOD) could represent a possibility because of bioaviability, safety, and its modulatory effect on the innate immune response in reducing the harmful consequences of oxidative stress. In this review we summarize the evidence on lecitinized superoxide dismutase in animal and human studies, to highlight the rationale for using the PC-SOD to treat COVID-19.

2019-12-01·International journal of clinical pharmacology and therapeutics4区 · 医学

Pharmacokinetics and safety of PC-SOD, a lecithinized recombinant superoxide dismutase, in healthy Chinese subjects: A phase 1, randomized, placebo-controlled, dose-escalation study

4区 · 医学

Article

作者: Liu, Chunyan ; Chen, Rui ; Wu, Ni ; Jin, Xin ; Zhu, Zhenyu ; Zhao, Qian ; Hu, Pei ; Zhong, Wen

OBJECTIVES:

To evaluate the pharmacokinetics of PC-SOD after single intravenous administration and its safety profile in healthy Chinese subjects.

MATERIALS AND METHODS:

This was a phase 1, randomized, double-blind, placebo-controlled, sequential, single-dose, and dose-escalation study. The study was done in 4 cohorts and a total of 40 subjects received a single dose of PC-SOD (from 20 to 160 mg). There were 12 subjects in each dose group (10 active treatments and 2 placebos), except a 20-mg group, in which all 4 subjects were given active treatment. Serial venous blood samples were collected up to 168 hours after dosing. Serum samples were analyzed using an enzyme-linked immunosorbent assay. Pharmacokinetic parameters of PC-SOD were calculated via noncompartmental analysis using the WinNonlin.

RESULTS:

After intravenous administration, PC-SOD reached the peak concentration quickly with a median t_max of 0.5 - 1.3 hours across all dose cohorts. After reaching C_max, the mean T_1/2 was 35.9 - 42.3 hours, which was independent of dose. The CL and V_z were 0.13 L/h and 6.72 L, 0.13 L/h and 7.33 L, and 0.11 L/h and 6.88 L for the 40, 80, and 160 mg dose cohorts, respectively. Over the dose range of 20 - 160 mg, the mean C_max increased from 5,546.6 to 44,145.2 h×ng/mL and AUC_last increased from 117,464.5 to 1,348,209.4 h×ng/mL. The 90% CI for β of AUC or C_max slightly exceeded the criterion, indicating that there was approximate dose proportionality over the range of 20 - 160 mg or 40 - 160 mg of PC-SOD. Generally, PC-SOD was well tolerated in doses up to 160 mg in healthy Chinese subjects. Reversible elevated blood triglyceride levels were reported in 2 subjects as moderate adverse events, and all other reported adverse events were considered to be mild. The possibility of a drug hypersensitivity syndrome was not high for PC-SOD in Chinese subjects based on current data.

CONCLUSION:

Single intravenous administrations of PC-SOD in doses up to 160 mg were well tolerated in healthy Chinese subjects. The prolonged half-life of PC-SOD was confirmed and independent of dose. Over the range of 20 - 160 mg, PC-SOD showed approximate dose proportionality. These findings suggest that it is worthwhile to investigate PC-SOD in clinical conditions characterized by a high radical overload.

100 项与磷脂化重组人铜锌超氧化物歧化酶(Beijing Tide Pharmaceutical) 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
心肌再灌注损伤	临床2期	中国	北京泰德制药股份有限公司	2019-06-18
心肌梗塞	临床1期	中国	北京泰德制药股份有限公司	2016-12-19

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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


EHA2023	N/A	血液肿瘤	85	Intermediate-dose AraC+G-CSF	糧蓋範醖製遞積鬱鬱窪(願淵鹽鹽襯鬱鏇餘選顧) = 簾餘繭範廠鏇餘夢廠鬱築襯繭膚願願襯壓餘積 (鬱窪鏇廠襯憲顧鑰糧鹹 )	-	2023-06-08
				Cy+G-CSF	糧蓋範醖製遞積鬱鬱窪(願淵鹽鹽襯鬱鏇餘選顧) = 觸憲製鑰蓋範顧繭膚壓築襯繭膚願願襯壓餘積 (鬱窪鏇廠襯憲顧鑰糧鹹 )