Preclinical Development of MucoCept

MucoCept 的临床前开发

基本信息

批准号：
9121468
负责人：
CRAIG R COHEN
金额：
$ 95.01万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-06 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9121468
关键词：
Acute Advanced Development Bacteria Behavioral Research Biological Assay Biological Response Modifier Therapy Blood Chronic Clinical Clinical Research Clinical Trials Cyanovirin-N Cyclic GMP Detection Development Development Plans Diagnostic Dose Enzyme-Linked Immunosorbent Assay Female Formulation Freeze Drying Funding Goals HIV Hydrogen Peroxide Laboratories Life Local Microbicides Measures Methodology Molecular Oryctolagus cuniculus Peer Review Phase I Clinical Trials Placebos Prevention Process Proteins Rattus Recombinants Research Tablets Testing Tissues Toxic effect United States Food and Drug Administration United States National Institutes of Health Vagina Work analytical method base cGMP production cell bank expectation improved irritation manufacturing process meetings method development microbicide novel therapeutics pre-clinical preclinical safety preclinical study product development programs reproductive tract safety study scale up vaginal fluid

项目摘要

The overall goal of the Integrated Pre-Clinical & Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP)-MucoCept is to advance the development of Lactobacil/us jensenii 1153-1666 as a recombinant live biotherapeutic product (rLBP), leading to the testing of MucoCept in a Phase 1 clinical trial following the completion of this IPCP. MucoCept, a candidate microbicide developed by Osei, Inc., is a fast dissolving vaginal tablet containing the hydrogen peroxide-producing vaginal L. jensenii strain that has been genetically modified to secrete a potent anti-HIV protein, modified cyanovirin-N (mCV-N), thus greatly improving its capabilities as a topical microbicide. Colonization of the vagina by L. jensenii 1153-1666 with continuous secretion of mCV-N is expected to reduce HIV acquisition in the female genital tract. After peer review, NIH DAIDS is now proposing to fund the remaining steps necessary for the completion for the preclinical development and IND submission, with the expectation that subsequent U01 applications will be submitted by the research team to fund the subsequent early clinical studies, behavioral research and laboratory methodology necessary for the clinical trials. The new scope of the project to be funded through a U01will conduct lnvestigational New Drug (IND) enabling studies to comply with Food and Drug Administration (FDA) requirements for an IND for MucoCept, and will optimize molecular-based diagnostics to measure colonization of by L jensenii 1153-1666 and secreted levels of mCV-N protein.

HIV菌皮和综合临床前和临床计划的总体目标生物医学预防（IPCP）-Mucocept是提高乳酸乳杆菌/美国Jensenii的发展 1153-1666作为重组生物治疗产品（RLBP），导致粘液cocce测试在第1阶段临床试验中此IPCP完成后。 Mucocept，由OSOI，Inc。开发的候选菌心，是一种快速溶解的阴道片经过遗传修饰以分泌有效的抗HIV蛋白的菌株，修饰 Cyanovirin-N（MCV-N），因此大大提高了其作为局部菌心的能力。 L. jensenii 1153-1666对阴道的殖民地殖民地殖民地殖民地MCV-N的连续分泌。减少女性生殖道中的HIV获取。经过同行审查后，NIH daids现在建议为临床前开发和提交的完成，期望随后 U01申请将由研究小组提交，以资助随后的早期临床临床试验所需的研究，行为研究和实验室方法。该项目的新范围将通过U01WILL行为lnvestigational New Drug（IND）资助使研究能够符合食品和药物管理局（FDA）的要求粘液concept，并将优化基于分子的诊断，以测量L Jensenii的定殖 1153-1666和MCV-N蛋白的分泌水平。