Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa

The purpose of this study is to assess the impact of LACTIN-V, a vaginally administered live biotherapeutic product (LBP) that contains the human L. crispatus CTV-05 strain, on the vaginal microbiome of Lactobacillus-deficient young women in the South African FRESH study who are at high risk for HIV acquisition.

开始日期2021-05-10

申办/合作机构

The University of California, San Francisco

[+5]

NCT03992534

/ Unknown status临床1期IIT

Feasibility, Safety, Tolerance and Assessment of LACTIN-V Use in a Cohort of Pregnant Women at Risk of Preterm Birth

Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

开始日期2019-09-16

申办/合作机构

Imperial College London

[+1]

NCT02766023

/ Completed临床2期IIT

Phase II-b Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus Crispatus CTV-05 (LACTIN-V) to Prevent the Recurrence of Bacterial Vaginosis

This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.

开始日期2016-06-03

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 CTV-05 相关的临床结果

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100 项与 CTV-05 相关的转化医学

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100 项与 CTV-05 相关的专利（医药）

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项与 CTV-05 相关的文献（医药）

2025-04-01·Lancet Microbe

Effect of the vaginal live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) on vaginal microbiota and genital tract inflammation among women at high risk of HIV acquisition in South Africa: a phase 2, randomised, placebo-controlled trial

Article

作者: Dong, Krista ; Mbano, Ian ; Demby, Suuba ; Ndung'u, Thumbi ; Brunner, Tess ; Kwon, Douglas S ; Xulu, Nondumiso ; Parks, Thomas P ; Moodley, Jayajothi ; Lagenaur, Laurel ; Cohen, Craig R ; Bergerat, Agnes ; Elsherbini, Joseph ; Shih, Johnathan ; Ngcapu, Sinaye ; Ismail, Nasreen ; Gebremichael, Musie ; Govender, Vaneshree ; Mitchell, Caroline M ; Xu, Jiawu ; Liebenberg, Lenine ; Hemmerling, Anke ; Casillas, Gardenia ; Pillay, Vanessa

BACKGROUND:

Absence of vaginal lactobacilli and accompanying genital inflammation is associated with HIV acquisition. We aimed to assess how a vaginal live biotherapeutic containing Lactobacillus crispatus affects cervicovaginal microbiota and markers of HIV susceptibility in South African women.

METHODS:

This randomised, placebo-controlled, phase 2 trial evaluated LACTIN-V (L crispatus CTV-05), a vaginal live biotherapeutic, compared with placebo in cisgender women in South Africa, aged 18-23 years, recruited at a community-based research clinic. Eligible participants with a Nugent score of 4-10 (indicating intermediate vaginal microbiota or bacterial vaginosis) completed 7 days of oral metronidazole and were randomly assigned (2:1) to LACTIN-V (2 × 10⁹ colony forming units per dose) or placebo (the substrate alone) via an independently generated randomisation sequence. Pharmacists, participants, and investigators were masked to treatment assignment. The study product (or placebo) was dosed daily for 5 days in week 1, then twice per week for an additional 3 weeks. Adverse events were evaluated 4 weeks and 8 weeks after starting the study product. Vaginal swabs (for 16S rRNA sequencing of the vaginal microbiome) and cervicovaginal lavage (for Luminex analysis of immune markers) were collected before metronidazole treatment, before study product (or placebo) administration, and at the week 4 and week 8 follow-up visits. An endocervical cytobrush for flow cytometry analysis of immune cell populations (including CD3⁺CD4⁺ T cells, and presence of CCR5 and the activation markers CD38 or HLA-DR) was collected before study product use and at 4 weeks and 8 weeks after study product use. The coprimary outcomes for the trial were (1) safety and acceptability of LACTIN-V, as measured by number of adverse events and a validated questionnaire; (2) presence of a Lactobacillus-dominant vaginal microbial community by 16S rRNA gene sequencing at week 4 and week 8; and (3) comparison of change in genital tract inflammatory markers from before metronidazole treatment to week 4 and week 8 between groups. Safety analyses were done in the intention-to-treat population and efficacy analyses in a modified intent-to-treat population (ie, excluding one person assigned placebo who erroneously received LACTIN-V). This trial is completed and registered on ClinicalTrials.gov (NCT05022212).

FINDINGS:

45 Black South African women were randomly assigned to receive LACTIN-V (n=32) or placebo (n=13). One woman in each group discontinued the trial during the intervention and two women discontinued during the follow-up. No severe or serious adverse events were observed. Solicited adverse events occurred in 35 (78%) of 45 participants with no significant difference by group (risk ratio 1·17, 95% CI 0·79-1·75; p=0·44). All local solicited adverse events were mild. 32 (71%) of 45 participants strongly agreed or agreed they would use the product again. L crispatus dominant microbiomes were identified in 13 (41%) of 32 participants in the LACTIN-V group at week 4 and eight (26%) of 31 at week 8, compared with none at week 4 and one (9%) of 11 in week 8 in the placebo group (week 4 p=0·0088; week 8 p=0·40). The proportion of activated endocervical HIV target cells out of total T cells increased from after metronidazole treatment to week 4 in the placebo group (median log₂ fold change 1·891, IQR 1·731-4·018) but not in the LACTIN-V group (1·062, 0·449-1·424; p=0·016). Changes in the concentrations of 13 immune markers from before metronidazole treatment to week 4 or week 8 were not significantly different by group.

INTERPRETATION:

The use of LACTIN-V after metronidazole significantly increased vaginal L crispatus colonisation during 4 weeks of use, although this increase was transient, and women in the placebo group had an increase in endocervical CD4⁺ HIV target cells during recovery compared with the LACTIN-V group. These results show that vaginal colonisation with an L crispatus live biotherapeutic is possible in an African context, and that optimisation of this strategy might be a way to decrease risk for HIV.

FUNDING:

US National Institute of Child Health and Human Development and US National Institute of Allergy and Infectious Diseases.

2024-08-06·Microbiology Spectrum

Vaginal fungi are associated with treatment-induced shifts in the vaginal microbiota and with a distinct genital immune profile

Article

作者: Crawford, Emily ; Liu, Rachel ; Armstrong, Eric ; Huibner, Sanja ; Kulikova, Maria ; Cohen, Craig R ; Castañeda, Gloria R ; Coburn, Bryan ; Hemmerling, Anke ; Kaul, Rupert ; Miller, Steve

ABSTRACT:

Vaginal colonization by fungi may elicit genital inflammation and enhance the risk of adverse reproductive health outcomes, such as HIV acquisition. Cross-sectional studies have linked fungi with an absence of bacterial vaginosis (BV), but it is unclear whether shifts in vaginal bacteria alter the abundance of vaginal fungi. Vaginal swabs collected following topical metronidazole treatment for BV during the phase 2b, placebo-controlled trial of LACTIN-V, a Lactobacillus crispatus -based live biotherapeutic, were assayed with semi-quantitative PCR for the relative quantitation of fungi and key bacterial species and multiplex immunoassay for immune factors. Vaginal fungi increased immediately following metronidazole treatment for BV (adjusted P = 0.0006), with most of this increase attributable to Candida albicans . Vaginal fungi were independently linked to elevated levels of the proinflammatory cytokine interleukin (IL) 17A, although this association did not remain significant after correcting for multiple comparisons. Fungal relative abundance by semi-quantitative PCR returned to baseline levels within 1 month of metronidazole treatment and was not affected by LACTIN-V or placebo administration. Fungal abundance was positively associated with Lactobacillus species, negatively associated with BV-associated bacteria, and positively associated with a variety of proinflammatory cytokines and chemokines, including IL-17A, during and after study product administration. Antibiotic treatment for BV resulted in a transient expanded abundance of vaginal fungi in a subset of women which was unaffected by subsequent administration of LACTIN-V. Vaginal fungi were positively associated with Lactobacillus species and IL-17A and negatively associated with BV-associated bacteria; these associations were most pronounced in the longer-term outcomes.

IMPORTANCE:

Vaginal colonization by fungi can enhance the risk of adverse reproductive health outcomes and HIV acquisition, potentially by eliciting genital mucosal inflammation. We show that standard antibiotic treatment for bacterial vaginosis (BV) results in a transient increase in the absolute abundance of vaginal fungi, most of which was identified as Candida albicans . Vaginal fungi were positively associated with proinflammatory immune factors and negatively associated with BV-associated bacteria. These findings improve our understanding of how shifts in the bacterial composition of the vaginal microbiota may enhance proliferation by proinflammatory vaginal fungi, which may have important implications for risk of adverse reproductive health outcomes among women.

2024-06-01·SEXUALLY TRANSMITTED DISEASES

Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease

Article

作者: Armstrong, Eric ; Wierzbicki, Michael R. ; Hemmerling, Anke ; Cohen, Craig R.

Objectives:

Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment.

Methods:

A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks.

Results:

At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35–0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47–2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure.

Conclusions:

LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.

项与 CTV-05 相关的新闻（医药）

2024-08-15

·CPHI制药在线

微生态药物研究进展

关注并星标CPHI制药在线微生态药物（live biotherapeutic products, LBP）又称活体菌药物，是指利用正常微生物或影响微生物生长代谢的物质制成的药物制剂，是继小分子、大分子、细胞治疗和基因治疗之后的另一种新型的药物形式，通过干预人体微生物群落来发挥治疗作用，目前以活体生物药为主。 2016年，美国食品药品监督管理局生物制品评价与研究中心(Food and Drug Administration Center for Biologics Evaluation and Research,FDA/CBER)发布了全球第一部明确将活体生物药作为药物使用的指南，该指南侧重的是活体生物药早期临床阶段化学制造和控制(chemical manufacturing and control, CMC)相关技术要求，明确了活体生物药的定义。活体生物药是一种生物活性药物，具有以下的特点：(1) 含有活的生物体，如细菌；(2) 具有预防、治疗人类疾病或适应证的功能；(3) 不是疫苗。其核心要素是要按新药的标准开发，明确适应症并进行系统的菌株安全性、药效、CMC以及临床评价。除了生物制品的一些共同特征以外，食品药品监督管理局(Food and Drug Administration, FDA)指南突出了活菌药物特有的研究重点，如鉴定菌株的稳定性、抗生素敏感性、耐药性、是否转移以及存在移位的可能，还有产品的生产控制与稳定性等。天然菌株 LBP 研发现状近年来，随着测序与分离技术的发展，人们不断发现了更多与疾病密切相关、但尚无人体应用历史的天然新菌种，并将其按照药物进行开发，成为天然菌株LBP，其包含单菌LBP和复合菌 LBP，这2种类型的LBP 已在多种疾病治疗的临床试验中有所报道。 01 单菌 LBP 的开发单菌LBP已在癌症、消化道疾病等多种疾病的研究领域中有所报道。在癌症治疗方面，英国4D pharma plc公司基于鸡肠球菌(Enterococcus gallinarum)开发了活体生物药MRx0518，该药物可以与pembrolizumab单抗联合治疗实体瘤，其机理是 MRx0518 的鞭毛蛋白可以激活细胞受体TLR5 和核因子(nuclear factor kappa-B, NF-κB)并诱导HT29-MTX细胞产生 IL-8，引发强烈的促炎反应，从而抑制肿瘤细胞的生长。此外，还有研究报道MRx0518可以与放射疗法联合治疗胰腺癌，受试者将在放射治疗开始前一周时每天服用MRx0518，且在整个放射治疗期间一直服用直至患者进行肿瘤切除手术。在消化道疾病方面，广州知易生物科技有限公司基于脆弱拟杆菌(Bacteroides fragilis)开发了SK08 药物，该药物可有效治疗肠应激综合征(irritable bowel syndrome, IBS)和溃疡性结肠炎(ulcerative colitis, UC)，并在临床前研究中展现出了良好的药效与安全性，多项研究表明，脆弱拟杆菌产生的多聚糖可调节辅助性 T 细胞 1(Th1)/(Th2)比例的平衡，增强机体 T 细胞的功能，同时可以诱导 Treg 细胞分化并产生 IL-10，抑制炎症因子 IL-17，从而达到调节机体的免疫功能的效果。4D pharma plc 公司开发了一种治疗克罗恩病(Crohn’s disease, CD)的LBP 药物—thetanix，该药物由一株多形拟杆菌(Bacteroides thetaiotaomicron)构成，其作用机理是抑制与多种炎症性疾病相关的NF-κB 活化，产生的 pirin-like 蛋白已成为候选效应分子，该药物在Ⅰb期临床试验中展现出良好的安全性，达到了预期结果。此外，单菌 LBP 在呼吸系统疾病、妇科疾病以及神经系统疾病的治疗中也有所报道，由短双歧杆菌(Bifidobacterium breve)制成的单菌药物 MRx-4DP0004 可治疗哮喘。OSel 公司基于干酪乳杆菌(Lactobacillus crispatus)开发了一种活体生物药 Lactin-V，该药物可以治疗复发性阴道炎。由马赛巨型球菌(Megasphaera massiliensis)构成的 MRx-0029 以及由狄氏副拟杆菌(Parabacteroides distasonis)构成的 MRx-0005在临床前均表现出治疗帕金森症的潜力，这2种菌株可以降低神经系统炎症反应，保护神经元免受氧化应激损伤并且恢复肠壁屏障完整性，目前这2款 LBP 的在研新药(investigational new drug, IND)申报已获得了FDA 批准，已进入临床试验阶段。 02 复合菌 LBP 的开发 21世纪初以来，艰难梭菌感染（CDI）一直是全球主要的公共卫生问题之一，基于粪菌移植 (fecal microbiota transplantation, FMT)的微生物组疗法在临床试验中对CDI疗效显著。Seres Therapeutics公司研发的复合菌药物SER-109是一种由纯化的厚壁菌门孢子组成的微生物组治疗剂，可以有效治疗 CDI，其核心逻辑是厚壁菌孢子有机体与艰难梭菌竞争性代谢生长所必需的营养素和胆汁酸，从而抑制艰难梭菌的繁殖。类似地，Rebiotix公司研发的复合菌药物RBX2660 是一种广谱微生物群混悬液，也可以治疗 CDI，该复合菌药物中的克劳氏芽孢杆菌和罗伊氏乳杆菌所分泌的化合物能抑制艰难梭菌的生长，此外该复合菌药物中的梭状芽孢杆菌代谢产生的次级胆汁酸能够增强艰难梭菌定殖抗性，同时提供营养生态位竞争的无毒艰难梭菌也会抑制艰难梭菌感染。此外，FinchTherapeutics 公司正在研发的CP-101 是一种胶囊给药的微生物组疗法，基于冻干保存的粪便，也用来防止CDI 复发。还有许多复合菌 LBP 是从唾液或粪便等生物样本中分离出来的微生物组治疗剂，这些细菌被分离以后可以在克隆细胞库中繁殖。VEDANTA公司研发的VE303包含8 种共生梭状芽孢杆菌菌株，可以治疗CDI。该公司的另一款药物VE800 是从健康人类供体粪便中分离出的由11种细菌菌株组成的联合体，这些菌株可以诱导CD8+ T 细胞的激活、增强免疫系统对肿瘤细胞的攻击能力并显著增强抗 PD-1治疗的效果，该药物与Nivolumab 联合治疗多种肿瘤已经取得了一定进展。VE202含有经试验鉴定后的11株粪便来源的菌株，该药物可以通过调节肠道菌群诱导免疫耐受进而治疗自身免疫性疾病，例如炎症性肠病(IBD)。此外，Biomica公司研发的复合菌药BMC128 含有4种来自人类肠道的天然菌株，它能够通过多种生物学过程增强免疫治疗效果并促进机体抗肿瘤免疫活性，从而抑制肿瘤的生长。MRM Health公司基于CORAL 平台开发了一种复合菌 LBP，该药物包含了经过合理搭配的9株肠道共生菌，在动物模型中，它能够改善门静脉高压、胰岛素信号传导、非酒精性脂肪肝活动指数以及预防肝纤维化的发展，还可以改善血管内皮功能、重塑肠道菌群。虽然FMT 疗法已经有诸多临床试验，但科学家始终无法掌握其明确的作用机制，因此具有一定的风险，包括不可预料的副作用、疗效不稳定和监管困难等。相比之下，成分明确的细菌组合体构成的复合菌 LBP 更加安全、可控，作用机制更加明确，人们更容易接受。基因工程菌株工程菌是采用现代生物工程技术加工出来的新型微生物，具有多功能、高效和适应性强等特点。近年来，微生物药物领域有较多工程菌已经进入临床研究阶段。研究表明，特定的酶或包含特定途径的工程益生菌能够缓解生物体的代谢紊乱，工程菌可以合成代谢所必需的酶从而恢复代谢，并且可以抑制有毒产物的合成或将其代谢成无毒产物，进而治疗此类代谢疾病。Synlogic 通过将编码苯丙氨酸解氨酶和 L-氨基酸脱氨酶的基因插入到大肠杆菌(Escherichia coli) Nissle 1917(缩写为“ECN”)的基因组中，得到苯丙酮尿症治疗药物 SYNB1934，在动物试验中，SYNB1618 可显著降低 Pahenu2/enu2小鼠的血浆苯丙氨酸浓度且防止健康的非人类灵长类动物(NHPs)食蟹猴血浆中苯丙氨酸浓度的激增。高尿酸治疗的菌株SYNB1353可消耗蛋氨酸，从而用于治疗高胱氨酸尿症。Advaxis的ADXS-503 (减毒活单核细胞增生李斯特菌)，单用和联合派姆单抗可用于治疗非小细胞肺癌 (NSCLC)。此外，还有多种工程菌用于治疗酶缺乏引起的代谢紊乱疾病、细菌感染、炎症性肠病和癌症等。随着人们对基因工程编辑药物的认识更加全面和客观，工程菌药物将会越来越受到人们的青睐，虽然人们对于转基因的安全性一直心存疑虑，但面对一些严重疾病的治疗剂选择，例如肿瘤治疗上，病人的抗风险能力更高，依从性和接受度更好。且工程菌药物拥有独特的优势，例如靶向性更好，可以增加目标部位的药物积累并最大限度地减少脱靶效应；给药的剂量低，产生的毒副作用也很小，最重要的是它可以通过人为改造，使其具有人们想要的特定功能，能够“因病制宜”，因此它的应用范围更广泛。小分子微生态调节剂小分子微生态调节剂 (small molecule microbiome modulator, SMMM) 是指能选择性地促进宿主肠道内的有益细菌生长繁殖的物质，通过促进有益菌的繁殖，抑制有害细菌的生长，达到调整肠道菌群，促进机体健康的目的。Second Genome的SGM-1019 可用于治疗非酒精性脂肪性肝炎 (NASH)；Enterome的 EB8018 可用于治疗炎症性肠病（IBD）；绿谷制药于2019 年 11 月在我国上市了甘露特钠胶囊(GV-971)，GV-971 可以调节肠道菌群失衡，抑制 α-突触核蛋白的聚集，减少肠道与脑内 α- 突触核蛋白的沉积，减轻神经炎症并保护多巴胺能神经元，改善运动和非运动症状。Intrinsic Medicine使用人乳寡糖小分子微生态调节剂治疗疼痛、调节肿瘤免疫、抗病毒和呼吸道感染等。参考资料： [1]朱永亮.活体菌药物产业化[J].生命科学,2023,35(03):340-346. [2]邹丹阳, 董雨萌, 陈晶瑜. 活体生物药：生物技术推动的创新药研发前沿[J].生物工程学报, 2023, 39(4): 1275-1289. 作者简介：小泥沙，食品科技工作者，现就职于国内某大型药物研发公司，从事营养食品及功能性食品的开发与研究。 END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

放射疗法疫苗基因疗法微生物疗法

2021-02-03

·BioSpace

Osel Obtains Exclusive License from Danish Research Consortia for IP Related to Osel’s LACTIN-V in Women Undergoing In-Vitro Fertilization

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced that it has entered into a definitive agreement with a consortia comprising Aarhus University, Skive Hospital and Statens Serum Institut of Denmark, and obtained the exclusive worldwide license to inventions resulting from an investigator-initiated Phase 2 trial of Osel’s investigational LBP, LACTIN-V, in women undergoing in-vitro fertilization (IVF). Financial terms were not disclosed. Osel is developing LACTIN-V, a proprietary formulation of Lactobacillus crispatus being studied in IVF, in addition to bacterial vaginosis (BV) and pre-term birth. Last year, Osel and colleagues published data in The New England Journal of Medicine demonstrating that LACTIN-V significantly reduced the recurrence of BV versus placebo in a Phase 2b trial. “Dysbiosis, or disruption of the vaginal microbiome, can lead to many problems in women’s health including BV and decreasing the success rate of IVF,” said Peter P. Lee, MD, Founder and Executive Chairman of Osel. “LACTIN-V, which contains the protective vaginal bacterial strain L. crispatus CTV-05, could help promote a healthier vaginal microbiome for IVF.” Under the agreement, the ongoing Phase 2 IVF trial is being conducted at four fertility clinics in Denmark and led by Professor Peter Humaidan, MD, Aarhus University and Skive Regional Hospital. The primary endpoint of the trial is clinical pregnancy at seven weeks post-embryo transfer in women with documented abnormal vaginal microbiota, which lowers the probability of successful IVF. “The vaginal microbiome and its importance for fertility is an intriguing new field of research. In the near future we hope to be able to define the most optimal vaginal microbiome – and importantly, to be able to modify the abnormal to normal,” said Professor Humaidan. “The ultimate goal of our research is to improve success rates of not only IVF, but also spontaneous pregnancy.” “LACTIN-V holds promise as the first treatment to increase the possibility of pregnancy from IVF, especially in women with vaginal dysbiosis,” said Thomas Parks, PhD, Director of Product Development at Osel. “While the trial’s progress was impacted by COVID-19, we expect to complete enrollment by the end of 2021/early 2022.” About Osel, Inc. Osel, Inc., a privately held biopharmaceutical company based in Mountain View, California, is focused on the development and commercialization of a portfolio of live biotherapeutic products (LBPs) to prevent or treat medical conditions resulting from disruption of the human microbiome (dysbiosis). The company is a pioneer in the field of LBPs, with a primary focus in women’s health. While many current microbiome treatments involve microbial transplants that are collected and processed from donor pools, Osel focuses on rigorously selected single strain products that are highly reproducible, scalable, and safe. Visit oselinc.com to learn more.

合作引进/卖出

100 项与 CTV-05 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
细菌性阴道炎	临床3期	美国	Osel, Inc.	2022-07-22
泌尿道感染	临床3期	美国	University of Washington	2015-09-01
HIV感染	临床2期	南非	Osel, Inc.	2021-05-10
女性生殖道感染	临床2期	美国	The Medicines Co.	2000-08-17
早产	临床1期	美国	Osel, Inc.	2022-07-22
念珠菌病	临床前	美国	Osel, Inc.	2011-08-31

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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


NCT05022212 (phase 2 placebo-controlled trial, CTgov)	临床2期	HIV感染 \| 细菌性阴道炎	45	LACTIN-V (LACTIN-V)	顧獵醖夢壓蓋膚襯憲鏇 = 獵鏇築網獵餘顧憲築構積糧選醖艱觸觸鹽蓋衊 (淵廠製鏇觸積廠衊壓網, 鹹遞願獵淵衊繭餘艱壓 ~ 衊獵醖積艱餘壓齋膚膚) 更多	-	2024-08-13
				Placebo (Placebo)	顧獵醖夢壓蓋膚襯憲鏇 = 襯憲窪構繭繭網繭觸獵積糧選醖艱觸觸鹽蓋衊 (淵廠製鏇觸積廠衊壓網, 糧願鹹選壓淵齋夢蓋網 ~ 夢鑰繭築選膚壓製構繭) 更多
NCT03151967 (CTgov)	临床2/3期	泌尿道感染	27	Lactobacillus crispatus CTV-05 (Applicator With LACTIN-V Treatment)	鑰艱糧觸顧網網構顧獵 = 襯積繭蓋簾鹽窪壓糧鏇製膚襯鹹顧糧膚窪鹹窪 (醖遞顧範網願襯夢餘齋, 選選獵鏇齋製廠築醖觸 ~ 構簾衊構鑰餘鹹顧廠構) 更多	-	2023-03-01
				Placebo (Applicator With Placebo)	鑰艱糧觸顧網網構顧獵 = 網鑰網膚築艱憲鏇餘範製膚襯鹹顧糧膚窪鹹窪 (醖遞顧範網願襯夢餘齋, 範鑰簾餘製醖願顧醖繭 ~ 鹹夢蓋憲窪鏇憲壓範壓) 更多
NCT02766023 (Pubmed) 人工标引	临床2期	细菌性阴道炎	228	Lactin-V	膚網膚選繭鏇艱鹽範鏇(鬱窪獵顧製淵憲蓋鬱鬱) = 壓積鹽膚觸憲網觸窪網餘簾鏇糧淵積夢鹽艱襯 (窪顧餘觸夢醖觸積選蓋 ) 更多	积极	2020-05-14
				Placebo	膚網膚選繭鏇艱鹽範鏇(鬱窪獵顧製淵憲蓋鬱鬱) = 襯鏇積獵醖鏇鹹蓋窪壓餘簾鏇糧淵積夢鹽艱襯 (窪顧餘觸夢醖觸積選蓋 )
NCT02766023 (CTgov)	临床2期	细菌性阴道炎	228	Metronidazole+Lactobacillus crispatus CTV-05 (LACTIN-V)	蓋顧襯鬱蓋觸簾願製齋 = 膚憲積廠襯範鹹憲獵選願積繭夢製鹹遞糧顧餘 (鬱遞憲構顧鏇鏇鏇膚積, 築鑰鬱簾選製襯膚鹹糧 ~ 鹽壓鹹鏇艱積廠願壓鹽) 更多	-	2020-02-11
				Placebo+Metronidazole (Placebo)	蓋顧襯鬱蓋觸簾願製齋 = 鹹襯衊廠構廠醖齋遞蓋願積繭夢製鹹遞糧顧餘 (鬱遞憲構顧鏇鏇鏇膚積, 鏇獵糧顧積窪獵鏇廠餘 ~ 網鹽選網窪鑰鹹醖夢衊) 更多
NCT00305227 (CTgov)	临床2期	泌尿道感染	100	Lactin-V (Lactin-V)	簾夢願鬱鬱鏇選餘鏇醖 = 艱遞廠鑰顧壓遞鹽衊築觸蓋鑰鹽鹹蓋製艱簾顧 (遞築鹽窪願廠淵淵襯齋, 壓齋網製憲繭顧鬱鏇鬱 ~ 構窪憲齋構鏇顧築築鹹) 更多	-	2014-07-04
				Placebo (Placebo)	簾夢願鬱鬱鏇選餘鏇醖 = 鏇範膚簾觸顧觸憲獵餘觸蓋鑰鹽鹹蓋製艱簾顧 (遞築鹽窪願廠淵淵襯齋, 築壓構糧鏇糧壓網築淵 ~ 構積糧鬱鑰襯簾餘鏇餘) 更多