Delving into the Latest Updates on PC-515 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Carraguard, Lambda-carrageenan, PC 515

Target-

Action

inhibitors

Mechanism

Virus internalization inhibitors

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases+ [1]

Active Indication-

Inactive Indication

Acquired Immunodeficiency SyndromeChlamydia trachomatis infectionGonorrhea+ [5]

Originator Organization

The Population Council, Inc.

Active Organization-

Inactive Organization

The Population Council, Inc.

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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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.

Start Date01 Jun 2002

Sponsor / Collaborator

The Population Council, Inc.

[+2]

NCT00213057

/ CompletedPhase 1IIT

A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

Start Date01 Jun 2001

Sponsor / Collaborator

The Population Council, Inc.

[+2]

100 Clinical Results associated with PC-515

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100 Translational Medicine associated with PC-515

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100 Patents (Medical) associated with PC-515

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166

Literatures (Medical) associated with PC-515

01 May 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Carrageenan-xanthan gum composite gel achieves the elimination of bitterness and easy swallowability of Coptis chinensis based on electrostatic induction and interpenetrating network interaction

Article

Author: Lu, Tai ; Chen, Zhencai ; Han, Li ; Liu, Qian ; Lin, Junzhi ; Han, Xue ; Tian, Yin ; Qiu, Min ; Zhang, Yifan ; Zhang, Dingkun ; Ke, Xiumei ; Song, Jiao

Natural polysaccharides possess the potential function of masking bitterness due to their three-dimensional network structures. However, they also have relatively high mechanical strength, which is not conducive to swallowing. Taking Coptis chinensis as an example, this study developed a composite gel composed of 0.17 % iota-carrageenan, 0.13 % lambda-carrageenan and 0.17 % xanthan gum. This composite gel can eliminate the bitterness and achieve good swallowability. Compared with the Coptis chinensis decoction, the bitterness of this gel is reduced by 60 %. Its hardness and crispness are only 1 % and 0.7 % of those of iota-carrageenan used alone. In addition, 60 % of the berberine in the composite gel can be released in artificial gastric juice within 10 min, and it has no significant impact on the hypoglycemic effects of Coptis chinensis. Further mechanism studies revealed that the sulfate group of iota-carrageenan disperses the electron cloud density of the bitter group of alkaloids through electrostatic induction, thus realizing the masking of bitterness. Meanwhile, the formation of an interpenetrating network structure between xanthan gum and carrageenan improves the swallowability. This study has developed a Coptis chinensis composite gel with excellent taste and easy swallowability, providing evidence for expanding the new applications of polysaccharides in masking taste.

01 Dec 2024·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

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

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.

01 Sep 2024·SEXUALLY TRANSMITTED INFECTIONS

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

Review

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

Background:

Carrageenan-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.

Methods:

We 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.

Results:

Of 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.

Conclusions:

Carrageenan-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.

100 Deals associated with PC-515

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 3	South Africa	The Population Council, Inc.	01 Apr 2004
HIV Seropositivity	Phase 3	South Africa	The Population Council, Inc.	01 Apr 2004
Herpes Simplex	Phase 2	Thailand	The Population Council, Inc.	01 Feb 2000
HIV Infections	Phase 2	Thailand	The Population Council, Inc.	01 Feb 2000
Chlamydia trachomatis infection	Phase 2	South Africa	The Population Council, Inc.	01 Oct 1999
Gonorrhea	Phase 2	South Africa	The Population Council, Inc.	01 Oct 1999
Syphilis	Phase 2	South Africa	The Population Council, Inc.	01 Oct 1999
Trichomonas Vaginitis	Phase 2	South Africa	The Population Council, Inc.	01 Oct 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00213083 (Pubmed \| Lancet)	Phase 3	HIV Infections	6,202	Carraguard	iqyuvuuxeu(dywaexhsdl) = ocasikrqmv cwahmssrtf (tochqmejxa, 2.8 - 3.9) View more	Negative	06 Dec 2008
NCT00213083 (Pubmed \| Lancet)	Phase 3	HIV Infections	6,202	Placebo (methylcellulose)	iqyuvuuxeu(dywaexhsdl) = wqbtjuqaas cwahmssrtf (tochqmejxa, 3.2 - 4.4) View more	Negative	06 Dec 2008
IAS2004	Not Applicable	-	55	Carraguard (2.5% methyl cellulose placebo)	eiblpmhive(tapfkujonl) = tkgkmhnzmn jzxsjdjums (gszsgywzgh ) View more	-	01 Jan 2004
IAS2004	Not Applicable	HIV Infections	194	microbicide (HIV-discordant couples)	zsamcisyfl(cacdowkxdc) = qlxslicfgx zulldcczfk (aobvbwvqwb )	-	01 Jan 2004
IAS2004	Not Applicable	HIV Infections	-	Carraguard	xexhitmxqt(ahideetkut) = ugevepdjku tqzdsxxqtu (rvivjltevb ) View more	-	01 Jan 2004
IAS2004	Not Applicable	HIV Infections	-	Placebo (methyl cellulose)	xexhitmxqt(ahideetkut) = cjynrgobru tqzdsxxqtu (rvivjltevb ) View more	-	01 Jan 2004
IAS2002	Not Applicable	Urinary Retention	-	Carraguard	jptcbxkoze(gtleuaegrq) = jqhpazmsyx fvpmxeoolx (xuwzwthady ) View more	-	01 Jan 2002
IAS2002	Not Applicable	-	400	Carraguard™	atdsmckuhs(qmzpihgtux) = nrkiwcsgrx npphycphvz (ukurtuyrwj ) View more	-	01 Jan 2002
IAS2002	Not Applicable	-	400	Placebo (methyl cellulose)	atdsmckuhs(qmzpihgtux) = snqklhfndn npphycphvz (ukurtuyrwj ) View more	-	01 Jan 2002