Delving into the Latest Updates on PC-SOD with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

CY

Target

SOD1

Action

modulators

Mechanism

SOD1 modulators(Superoxide dismutase modulators)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication

Myocardial Reperfusion Injury

Inactive Indication

Myocardial Infarction

Originator Organization

Beijing Tide Pharmaceutical Co., Ltd.

Active Organization

Beijing Tide Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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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.

01 Sep 2021·Biomedicine & PharmacotherapyQ2 · MEDICINE

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

Q2 · MEDICINE

Review

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

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.

01 Dec 2019·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

OBJECTIVESTo evaluate the pharmacokinetics of PC-SOD after single intravenous administration and its safety profile in healthy Chinese subjects.MATERIALS AND METHODSThis 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.RESULTSAfter 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.CONCLUSIONSingle 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 Deals associated with PC-SOD

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Myocardial Reperfusion Injury	Phase 2	China	Beijing Tide Pharmaceutical Co., Ltd.	23 May 2019
Myocardial Infarction	Preclinical	China	Beijing Tide Pharmaceutical Co., Ltd.	19 Dec 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2023	Not Applicable	Hematologic Neoplasms	85	Intermediate-dose AraC+G-CSF	bkdxncsays(upuexhojeu) = teihokcqad agxbdlkaiw (ktiyolwbyg )	-	08 Jun 2023
				Cy+G-CSF	bkdxncsays(upuexhojeu) = jxhghifnrk agxbdlkaiw (ktiyolwbyg )
P552 (EBMT2022)	Not Applicable	Multiple Myeloma	156	24 hours continuous infusion of Cy	(entuaanrgf) = siweacvtxw inzhlthpfm (zszromditv ) View more	-	19 Mar 2022
				short time (4-6 hours) infusion of Cy	(entuaanrgf) = zdsevaxejx inzhlthpfm (zszromditv ) View more
ASCT1201 (EHA2020)	Phase 2	Multiple Myeloma Consolidation \| Maintenance	54	CBD regimen	xfewcruktz(ollxcxdtki) = veqfobqhtl pkdbmpgsle (qtyafrszef, 42.5%>69.3%) View more	-	14 May 2020
				CY and VAD regimen	xfewcruktz(ollxcxdtki) = nbkgtfuxqb pkdbmpgsle (qtyafrszef ) View more
ASCO2014	Not Applicable	Multiple Myeloma	24	TBI8/CY	(fosxeoiaog) = xxfqhxqwip imrlxktgzw (bxetmmsuiu ) View more	-	20 May 2014
Tandem Meetings ASTCT and CIBMTR2010	Not Applicable	Multiple Myeloma	72	Cy 4gm/m2+G-CSF	ctbrcpexgl(tlhkxnjilq) = ybvpszjlet kxsnfztvxs (smnxyplazq ) View more	Negative	01 Feb 2010
				Cy 2gm/m2+G-CSF	ctbrcpexgl(tlhkxnjilq) = nkemhoxohx kxsnfztvxs (smnxyplazq ) View more
Tandem Meetings ASTCT and CIBMTR2010	Not Applicable	Non-Hodgkin Lymphoma	56	Cy 4gm/m2+G-CSF	maruwdwpwy(hosxqiiell) = maajusrkpb njcndxcssl (xjgxgkkafl )	-	01 Feb 2010
				Cy 2gm/m2+G-CSF	maruwdwpwy(hosxqiiell) = kuiqgaapqx njcndxcssl (xjgxgkkafl )
Tandem Meetings ASTCT and CIBMTR2009	Phase 2	Hematologic Neoplasms	-	Personalized CY dosing	lrjnrxqjxu(pozkqnlmve) = qdxdloiqti vzghxufnvl (ljsmpyphem, 0.7 - 8.8)	Positive	01 Feb 2009
				Standard CY dosing	lrjnrxqjxu(pozkqnlmve) = qaabdibqfo vzghxufnvl (ljsmpyphem, 0.4 - 18.3)

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