PC-515(PC-515) - _专利_临床

概要

基本信息

药物类型

小分子化药

别名

Carraguard、Lambda-carrageenan

靶点-

作用机制

病毒内化抑制剂

治疗领域

免疫系统疾病感染泌尿生殖系统疾病+ [1]

在研适应症-

非在研适应症

获得性免疫缺陷综合征淋病单纯疱疹+ [4]

原研机构

The Population Council, Inc.

在研机构-

非在研机构

The Population Council, Inc.

最高研发阶段无进展临床3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

6

项与 PC-515 相关的临床试验

ISRCTN15435307

/ RecruitingN/AIIT

Effects of carrageenan nasal spray as additive therapy on quality of life and clinical outcome in patients diagnosed with chronic rhinosinusitis

开始日期2017-09-01

申办/合作机构

Medical University of Vienna

NCT00213083

/ Completed临床3期IIT

Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women

The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

开始日期2004-04-01

申办/合作机构

The Population Council, Inc.

[+1]

NCT00213005

/ Completed临床1期IIT

A Phase 1 Safety and Acceptability Study of Carraguard® Among HIV Positive Women and Men in Durban, South Africa

The study objectives were to assess the mucosal safety of Carraguard® gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported by female and male participants during the study may be related to the use of Carraguard® gel; and to examine dimensions of the acceptability of, and compliance with, the study and placebo products.

开始日期2002-06-01

申办/合作机构

The Population Council, Inc.

[+2]

100 项与 PC-515 相关的临床结果

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100 项与 PC-515 相关的转化医学

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100 项与 PC-515 相关的专利（医药）

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189

项与 PC-515 相关的文献（医药）

2024-12-01·International Journal of Biological Macromolecules

Lambda carrageenan displays antiviral activity against the infectious pancreatic necrosis virus (IPNV) by inhibiting viral replication and enhancing innate immunity in salmonid cells

Article

作者: Espinoza, Daniela ; Moenne, Alejandra ; Imarai, Mónica ; Sandino, Ana María ; Martínez, Fabián ; Valdés, Natalia ; Laporte, Daniel

Sulfated polysaccharide lambda carrageenan (λ-CGN) was evaluated for its antiviral effect against IPNV using the in vitro infection model of CHSE-214 salmonid cells. A plaque reduction lysis assay revealed that λ-CGN has an IC₅₀ of 0.9 μg⋅mL^-1, CC₅₀ > 128 μg⋅mL^-1 and a Selectivity Index (SI) > 142. In comparison, iota, kappa carrageenans and lambda oligo-carrageenan (λ-OC) were less effective than λ-CGN against IPNV. λ-CGN showed no virucidal activity when applied directly to viral particles. Time of addition experiments showed that pre-treatment, co-treatment, and post-treatment with λ-CGN significantly reduced viral RNA copies in the cell supernatant. Additionally, a decrease in intracellular viral RNA was observed with pre-treatment and post-treatment, indicating an impact on different stages of viral replication. Polyacrylamide gel electrophoresis of IPNV genomic RNA in presence of λ-CGN showed a reduction in the level of viral genomic RNA. Confocal microscopy confirmed the intracellular localization of λ-CGN, suggesting that λ-CGN may inhibit the synthesis of IPNV genomic RNA. Moreover, cells pre-treated with λ-CGN showed an increased expression of innate immunity genes CXCL11, IL1β, IFNa, and IRF3. These findings highlight the need for further research to confirm the in vivo pharmacological potential of λ-CGN as a new antiviral agent in salmonids.

2024-09-01·Sexually Transmitted Infections

Safety of carrageenan-based gels as preventive microbicides: a narrative review

Review

作者: Laurie, Cassandra ; Franco, Eduardo L ; El-Zein, Mariam

BackgroundCarrageenan-containing gels researched for the prevention of sexually transmitted infections (STIs) have shown promising results for human papillomavirus prevention in women, but not in men. We conducted a narrative review to assess the safety of these gels for genital use.MethodsWe searched PubMed using MeSH terms and keywords on 5 November 2023. Title/abstract of articles were screened to identify relevant ones. Full-text screening determined eligibility: empirical study evaluating safety of carrageenan-containing gel(s) for genital use.ResultsOf the 125 identified records, 15 were eligible, comprising 14 (10 randomised controlled trials and 4 cohorts) unique study populations. Studies included women only (n=11), men only (n=1) or both (n=3); number of participants ranged from 4 to 6202. Safety was assessed for vaginal (n=13), penile (n=3) and anal use (n=2). Most studies assessed safety of Carraguard (53%), followed by Divine9 (14%), and one each of iota-carrageenan gel, lambda-carrageenan gel, Carvir, PC-6500 (griffithsin and carrageenan) and PC-1005 (MIV-150/zinc acetate/carrageenan). Safety assessment relied on self-report (80.0%), testing for STIs (53.3%), investigator-identified genital findings (93.3%) and/or testing for changes in genital flora (60.0%). Adverse events (AEs) were described by investigators as mostly mild, (mostly) comparable between groups, not observed and/or not significant for vaginal and penile use. Only one study, assessing anal use of carrageenan, reported a significantly higher proportion of AEs in the carrageenan compared with placebo group.ConclusionsCarrageenan-based gels are generally well tolerated for vaginal and penile, but not anal use. Studies on carrageenan gel’s safety for anal use are scarce.

2022-08-01·American Journal of Veterinary Research

Evaluation of weight-bearing, locomotion, thermal antinociception, and footpad size in a carrageenan-induced inflammatory model in the cockatiel (Nymphicus hollandicus)

Article

作者: Beaufrere, Hugues ; Paul-Murphy, Joanne ; Sanchez-Migallon Guzman, David ; Mikoni, Nicole A.

AbstractOBJECTIVESTo evaluate a carrageenan-induced inflammatory model in the cockatiel (Nymphicus hollandicus) using weight-bearing load, rotational perch locomotion, thermal threshold withdrawal, and footpad dimensions.ANIMALS16 adult cockatiels (8 males and 8 females).PROCEDURESCockatiels were randomly assigned into 2 groups as either treatment (carrageenan injection; n = 8) or control (handling only; 8). Treatment of cockatiels involved unilateral subcutaneous injection of 0.05 mL of 1% lambda carrageenan solution into the left footpad. Control birds were handled in a similar manner without an injection. Following baseline measurements and treatment or control procedures, posttreatment measurements at multiple time points involving weight-bearing perch load (for up to 336 hours), locomotive abilities when placed on a rotating perch (for up to 96 hours), thermal withdrawal threshold (for the 24- to 30-hour period), and both vertical and horizontal left footpad size and degree of swelling (for up to 84 days) were obtained.RESULTSTreatment cockatiels had a significant decrease in left foot weight-bearing load and increase in left footpad dimensions and swelling grade over time compared to control cockatiels. Rotational perch locomotion and thermal withdrawal threshold, conversely, did not differ significantly between groups. Cockatiels injected with carrageenan returned to normal weight-bearing within 2 weeks; however, left footpad dimensions did not return to baseline.CLINICAL RELEVANCECarrageenan footpad injection prompts a measurable and grossly visible inflammatory response in the cockatiel. Additionally, it induces alterations in weight-bearing distribution in injected birds. This model provides a method to evaluate inflammation and lameness in small psittacine species.

100 项与 PC-515 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
获得性免疫缺陷综合征	临床3期	南非	The Population Council, Inc.	2004-04-01
HIV血清阳性	临床3期	南非	The Population Council, Inc.	2004-04-01
单纯疱疹	临床3期	泰国	The Population Council, Inc.	2000-02-01
HIV感染	临床3期	泰国	The Population Council, Inc.	2000-02-01
淋病	临床3期	南非	The Population Council, Inc.	1999-10-01
梅毒	临床3期	南非	The Population Council, Inc.	1999-10-01
滴虫性阴道炎	临床3期	南非	The Population Council, Inc.	1999-10-01

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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


NCT00213083 (Pubmed \| Lancet)	临床3期	HIV感染	6,202	Carraguard	襯蓋廠蓋構廠餘鹹齋鏇(顧衊鬱鹽鏇衊鑰淵衊範) = 膚繭簾淵糧繭鹽鏇繭艱構簾築壓壓構憲鹹鹽顧 (醖繭範餘夢積簾餘淵網, 2.8 ~ 3.9) 更多	不佳	2008-12-06
				Placebo (methylcellulose)	襯蓋廠蓋構廠餘鹹齋鏇(顧衊鬱鹽鏇衊鑰淵衊範) = 蓋憲構製憲淵窪觸壓齋構簾築壓壓構憲鹹鹽顧 (醖繭範餘夢積簾餘淵網, 3.2 ~ 4.4) 更多
IAS2004	N/A	HIV感染	-	Carraguard	壓鹽鏇繭構鑰範蓋範襯(襯鏇製憲構蓋窪願鏇網) = 壓築構積網鑰遞廠範顧範選壓積餘簾構簾積糧 (鏇製鏇築夢顧構積淵艱 ) 更多	-	2004-01-01
				Placebo (methyl cellulose)	壓鹽鏇繭構鑰範蓋範襯(襯鏇製憲構蓋窪願鏇網) = 廠窪壓繭網鏇憲鹹夢鹹範選壓積餘簾構簾積糧 (鏇製鏇築夢顧構積淵艱 ) 更多
IAS2002	N/A	尿潴留	-	Carraguard	築製繭鹽壓鏇鏇廠淵築(襯鹹製醖衊壓餘網積繭) = 構積鑰窪製範衊襯襯憲簾襯鑰鬱鬱觸願範顧鏇 (積壓蓋繭膚蓋鏇鬱繭餘 ) 更多	-	2002-01-01
IAS2002	N/A	-	400	Carraguard™	齋衊憲夢糧鹹淵鏇餘積(餘構醖蓋齋衊顧醖憲齋) = 艱鏇範願艱觸憲選糧醖襯願襯遞醖鏇艱艱願繭 (鑰鬱鏇齋蓋艱蓋遞壓繭 ) 更多	-	2002-01-01
				Placebo (methyl cellulose)	齋衊憲夢糧鹹淵鏇餘積(餘構醖蓋齋衊顧醖憲齋) = 廠鑰願簾製觸鏇願簾廠襯願襯遞醖鏇艱艱願繭 (鑰鬱鏇齋蓋艱蓋遞壓繭 ) 更多