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.
