Preclinical Development of MucoCept

艾滋病毒杀微生物剂和艾滋病综合临床前和临床方案的总体目标 生物医学预防(IPCP)-MucoCept是为了促进Jensenii乳杆菌的发展 1153-1666作为重组活生物治疗产品(RLBP)，导致检测MucoCept 在一期临床试验中 在完成这一IPCP之后。Osei，Inc.开发的候选杀菌剂MucoCept， 是一种快速溶解的阴道片，含有产生过氧化氢的阴道詹森氏杆菌 一种经过转基因的菌株，可以分泌一种有效的抗艾滋病毒蛋白，经过修改 氰韦林-N(MCV-N)，从而极大地提高了其作为局部杀菌剂的能力。 持续分泌MCV-N的詹森乳杆菌1153-1666有望在阴道内定植 以减少艾滋病毒在女性生殖道的感染。 经过同行审查，NIH DAIDS现在提议为剩余的必要步骤提供资金 完成临床前开发和IND提交，预计后续 U01申请将由研究团队提交，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学。 通过U01资助的项目的新范围将进行新药研究(IND) 使研究符合食品和药物管理局(FDA)对IND的要求 MucoCept，并将优化基于分子的诊断来测量L Jensenii的定植 1153-1666，并分泌MCV-N蛋白。

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.