A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)

The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.

开始日期2025-01-28

申办/合作机构

TR Therapeutics, Inc.

NCT03154619

/ Unknown status临床2期

Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers: a Two-arm, Double-blind, Placebo-controlled, Randomized Controlled Trial.

The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.

开始日期2016-11-01

申办/合作机构

SerenaGroup, Inc.

[+1]

NCT00792688

/ Completed临床2期

Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.

The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.

开始日期2008-10-01

申办/合作机构

TR Therapeutics, Inc.

100 项与 TR-987 相关的临床结果

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100 项与 TR-987 相关的转化医学

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100 项与 TR-987 相关的专利（医药）

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项与 TR-987 相关的文献（医药）

2011-05-01·Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society3区 · 医学

Particulate β‐glucan induces TNF‐α production in wound macrophages via a redox‐sensitive NF‐κβ‐dependent pathway

3区 · 医学

Article

作者: Gayle M. Gordillo ; Chandan K. Sen ; Ryan Dickerson ; Savita Khanna ; Urmila Gnyawali ; Sashwati Roy ; Eric Collard

ABSTRACT:

Glucans are known to promote wound repair. Noncellulosic β‐glucans are recognized as potent immunological activators. β‐Glucans are generally safe and are known to attenuate the rate of postoperative infection. Glyc101 is a particulate β‐glucan isolated from Saccharomyces cerevisiae. In this study, the hypothesis that Glyc101 regulates wound macrophage function was tested. Glyc101 induced tumor necrosis factor (TNF) α transcription in macrophages isolated from murine wound site. Multiplex assay identified interleukin (IL)‐10 and TNFα as two cytokines that are induced by Glyc101 in human blood monocyte‐derived macrophages. Glyc101‐induced TNFα production was observed to be mediated via the TLR‐2 and dectin‐1 receptors, receptor tyrosine kinases and NFκB activation. In murine wound macrophages, Glyc101 potentiated phorbol 12‐myristate 13‐acetate‐induced respiratory burst. In vivo, implantation of Glyc101‐enriched polyvinyl alcohol‐sponges at the wound‐site induced TNFα expression in macrophages. Consistently, Glyc101 induced TNFα expression in wound‐site macrophages isolated from two patients with chronic wounds. These observations establish the translational significance of the net findings of this study. Activation of wound macrophages by Glyc101 represents one of the potential mechanisms by which this β‐glucan may benefit chronic wounds where inefficient inflammatory response is one of the underlying causes of impaired healing.

项与 TR-987 相关的新闻（医药）

2025-08-24

·药明康德

使100%患者获完全缓解的联合疗法；使100%患者产生抗体的新型疫苗…… | 一周盘点

本期看点 1. Tuspetinib联用标准剂量的venetoclax和azacitidine（TUS+VEN+AZA三联疗法）在一项针对新确诊的急性髓系白血病（AML）患者的1/2期临床试验中表现亮眼，在80 mg和120 mg TUS剂量水平下接受治疗的所有受试者均达到了完全缓解（CR）或部分血液学恢复的完全缓解（CRh）。 2. 新型带状疱疹候选疫苗Z-1018在针对50至69岁人群的1/2期临床试验中取得了积极的顶线结果，该疫苗展现出与活性对照疫苗相当的抗体和CD4阳性T细胞免疫应答，且耐受性良好。 Tuspetinib：公布1/2期联合治疗试验的新数据 Aptose Biosciences公司公布了其针对新确诊的AML患者开展的1/2期TUSCANY试验的新数据。这些患者接受了不同剂量的tuspetinib联用标准剂量的venetoclax和azacitidine。该三联疗法正在被开发作为一种安全且不依赖于特定突变的一线治疗方案，用于治疗那些无法接受诱导化疗的新确诊AML患者，这些患者具有多样的突变。此次公布的结果显示，在VEN+AZA中加入TUS可提高缓解率和最小残留病（MRD）阴性率。在80 mg和120 mg TUS剂量水平下接受治疗的所有受试者均达到了CR/CRh，且120 mg TUS剂量组达到缓解的时间比40 mg和80 mg剂量组更早。在对治疗产生应答的患者中，9人中有7人（78%）达到了MRD阴性，预计通过持续的长期治疗，患者的生存期将进一步延长。在FLT3野生型AML患者（占AML患者群体约70%）中，该三联疗法实现了100%的CR/CRh；在TP53、RAS及FLT3-ITD突变型AML患者中，CR/CRh率和MRD阴性率均为100%。安全性方面，该三联疗法的安全性和耐受性良好，在已评估的剂量水平下均未观察到剂量限制性毒性（DLT）。 Z-1018：公布1/2期临床试验数据 Dynavax Technologies公司宣布，其新型带状疱疹候选疫苗Z-1018在针对50至69岁人群的1/2期临床试验中取得了积极的顶线结果。Z-1018是一款在研带状疱疹疫苗，采用Dynavax公司生产的糖蛋白E（gE）抗原，并辅以公司专有的CpG 1018佐剂。基于该部分试验结果，公司计划将Z-1018推进至1/2期临床试验的第二部分，针对70岁及以上的成年人，预计于2025年下半年启动。在第二剂疫苗接种后一个月的评估时间点，Z-1018展现出与活性对照Shingrix（一款已获批的带状疱疹疫苗）相当的抗体和CD4阳性T细胞免疫应答，且耐受性良好。在选定用于第二部分试验的剂量、配方和接种方案下，Z-1018组的体液免疫应答（抗体产生）率达到100.0%，对照组为96.9%；细胞免疫应答（CD4阳性T细胞反应）率为89.7%，对照组为93.5%，两组的综合免疫应答率分别为89.7%和90.3%。在选定方案中，接种Z-1018的受试者中出现2/3级局部和全身注射后反应（PIR）的比例分别为12.5%和27.5%，显著低于对照组的52.6%和63.2%。 BGE-102：1期临床试验完成首例受试者给药 BioAge公司宣布，其用于治疗肥胖症的候选药物BGE-102的1期临床试验已完成首例受试者给药。BGE-102是一种结构新颖、可口服的小分子NLRP3抑制剂，具有高活性及良好的脑渗透性，旨在开发用于治疗肥胖症。NLRP3是驱动与年龄相关炎症的关键因子，与肥胖、神经退行性疾病及心血管疾病密切相关。该公司基于人类衰老队列分析发现，NLRP3活性降低与长寿相关，因此将其确立为潜在治疗靶点。BGE-102通过独特的结合位点和机制抑制NLRP3炎性小体，作用方式区别于其他在研NLRP3抑制剂。在临床前肥胖模型中，BGE-102单药治疗实现了高达15%的剂量依赖性体重减轻，疗效与司美格鲁肽（semaglutide）相当。与司美格鲁肽联用后，动物模型的体重减轻约25%，显示出叠加效应。该化合物具有高效力，且脑渗透性强，支持每日一次口服给药。此外，该化合物在毒理研究中表现出优异的安全性，未见任何不良事件，展现出解决神经炎症（破坏大脑食欲调节）以及与肥胖和心血管风险相关的全身炎症的潜力。 SL-325：IND申请获得FDA许可 Shattuck Labs宣布，其用于治疗炎症性肠病（IBD）的在研新药SL-325的IND申请已获得美国FDA的许可。SL-325是一款潜在“first-in-class”死亡受体3（DR3）阻断抗体，是一种完全Fc段沉默的人源化IgG单克隆抗体，旨在实现对临床验证的DR3/TL1A通路的完全和持久阻断。临床前研究显示，SL-325对人源DR3具有高亲和力结合能力，并能有效抑制TL1A与DR3的结合。在非人灵长类动物研究中，该药物表现出良好的安全性。参考资料： [1] Memo Therapeutics AG Publishes Phase I Safety, Tolerability, and Pharmacokinetics Study for Neutralizing Antibody Targeting BKPyV Infection in Clinical and Translational Science. Retrieved August 22, 2025, from https://memo-therapeutics.com/2025/08/19/memo-therapeutics-ag-publishes-phase-i-safety-tolerability-and-pharmacokinetics-study-for-neutralizing-antibody-targeting-bkpyv-infection-in-clinical-and-translational-science/ [2] COUR Pharma Doses First Patient in Clinical Trial Evaluating CNP-103 in People Recently Diagnosed with Type 1 Diabetes. Retrieved August 22, 2025, from https://www.globenewswire.com/de/news-release/2025/08/19/3135630/0/en/COUR-Pharma-Doses-First-Patient-in-Clinical-Trial-Evaluating-CNP-103-in-People-Recently-Diagnosed-with-Type-1-Diabetes.html [3] ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors. Retrieved August 22, 2025, from https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-doses-first-patient-phase-1-dose-escalation-trial [4] Kelonia Therapeutics Doses First Patient in Phase 1 inMMyCAR Study Evaluating in vivo CAR T-cell Therapy for Relapsed and Refractory Multiple Myeloma. Retrieved August 22, 2025, from https://keloniatx.com/kelonia-therapeutics-doses-first-patient-in-phase-1-inmmycar-study-evaluating-in-vivo-car-t-cell-therapy-for-relapsed-and-refractory-multiple-myeloma/ [5] Opus Genetics Announces FDA Clearance of IND Application for Gene Therapy Candidate OPGx-BEST1. Retrieved August 22, 2025, from https://ir.opusgtx.com/press-releases/detail/495/opus-genetics-announces-fda-clearance-of-ind-application-for-gene-therapy-candidate-opgx-best1 [6] BioAge Labs Announces First Participant Dosed in Phase 1 Clinical Trial of BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor. Retrieved August 22, 2025, from https://ir.bioagelabs.com/news-releases/news-release-details/bioage-labs-announces-first-participant-dosed-phase-1-clinical [7] Athira Pharma Presents ATH-1105 Phase 1 Trial Results at ALS Nexus 2025. Retrieved August 22, 2025, from https://www.globenewswire.com/news-release/2025/08/14/3133303/0/en/Athira-Pharma-Presents-ATH-1105-Phase-1-Trial-Results-at-ALS-Nexus-2025.html [8] Aptose Reports Early Data Demonstrating Tuspetinib Improves Standard of Care Treatment Across Diverse Populations of Newly Diagnosed AML in Phase 1/2 TUSCANY Trial. Retrieved August 22, 2025, from https://www.globenewswire.com/news-release/2025/08/18/3134929/35575/en/Aptose-Reports-Early-Data-Demonstrating-Tuspetinib-Improves-Standard-of-Care-Treatment-Across-Diverse-Populations-of-Newly-Diagnosed-AML-in-Phase-1-2-TUSCANY-Trial.html [9] Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis. Retrieved August 22, 2025, from https://enlivex.com/investors/news-releases/enlivex-announces-positive-topline-data-from-multi-country-randomized-controlled-phase-i-ii-trial-evaluating-allocetra-in-patients-with-moderate-to-severe-knee-osteoarthritis/ [10] Dynavax Announces Positive Topline Phase 1/2 Results Supporting Potential Best-in-Class Shingles Vaccine Profile. Retrieved August 22, 2025, from https://www.prnewswire.com/news-releases/dynavax-announces-positive-topline-phase-12-results-supporting-potential-best-in-class-shingles-vaccine-profile-302535373.html [11] Shattuck Labs Announces IND for SL-325 Is in Effect for the Treatment of Inflammatory Bowel Disease. Retrieved August 22, 2025, from https://www.globenewswire.com/news-release/2025/08/21/3137278/0/en/Shattuck-Labs-Announces-IND-for-SL-325-Is-in-Effect-for-the-Treatment-of-Inflammatory-Bowel-Disease.html [12] SMSbiotech Initiates Groundbreaking Phase 1 Human Clinical Trial for COPD. Retrieved August 22, 2025, from https://www.businesswire.com/news/home/20250821443319/en/SMSbiotech-Initiates-Groundbreaking-Phase-1-Human-Clinical-Trial-for-COPD 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果疫苗临床2期

100 项与 TR-987 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性静脉功能不全	临床3期	美国	TR Therapeutics, Inc.	2025-01-28
静脉曲张溃疡	临床3期	美国	TR Therapeutics, Inc.	2025-01-28
创伤和损伤	临床3期	美国	TR Therapeutics, Inc.	2025-01-28

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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


WCD2023	临床2期	慢性静脉功能不全	82	TR987® 0.1% gel	簾築網窪遞衊鬱鑰艱構(艱蓋憲簾構鹹艱夢觸餘) = 遞蓋願襯廠築遞築簾製壓觸糧淵網選夢鹽獵鏇 (蓋艱衊壓製觸遞鑰築獵 ) 更多	积极	2023-07-03
				Placebo gel	簾築網窪遞衊鬱鑰艱構(艱蓋憲簾構鹹艱夢觸餘) = 糧顧膚遞顧製齋膚齋範壓觸糧淵網選夢鹽獵鏇 (蓋艱衊壓製觸遞鑰築獵 ) 更多
NCT00656474 (CTgov)	临床1/2期	创伤和损伤	12	GLYC-101 (GLYC-101 Active Retro-auricular Site (1 Per Participant))	積鏇膚選顧憲餘夢選鬱(艱繭鹹醖齋遞鏇蓋積鏇) = 積鏇蓋鹹艱鏇獵鬱選觸鹹獵積選網範獵鹽衊淵 (夢齋鏇築鹽窪觸醖製構, 顧遞膚壓觸壓艱衊製鏇 ~ 餘廠窪齋鏇製膚壓衊鹹) 更多	-	2011-07-25
				Placebo (Placebo Retro-auricular Site (1 Per Participant))	積鏇膚選顧憲餘夢選鬱(艱繭鹹醖齋遞鏇蓋積鏇) = 廠廠壓範壓鹽廠遞鬱觸鹹獵積選網範獵鹽衊淵 (夢齋鏇築鹽窪觸醖製構, 繭廠鹽範鹽範鏇繭蓋觸 ~ 遞鏇淵夢構觸觸夢網艱) 更多