Preclinical development of PPCM vaginal contraceptive to submit IND.

Yaso Therapeutics Inc, Phoenix AZ

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY The goal of this project is to develop a novel vaginal contraceptive gel product containing PPCM sodium salt (PPCM). PPCM is a novel polymer drug that inhibits infection of HSV, HIV, N. gonorrhea and is also contraceptive. This novel drug has an average molecular weight of 3900, is designed to be used topically, and thus far passed all safety studies and does not appear to be systemically absorbed. PPCM has been the subject of several publications. Development of a topical gel containing PPCM as a preventive and treatment product for genital herpes has been funded through three earlier STTR/SBIR grants. We have taken the drug from the bench to a defined drug with a full suite of analytical methods, a defined manufacturing method with a C of A and Reference Standard Batch, conducted two forced degradation studies, numerous formulations and numerous animal safety and efficacy studies. Under this grant proposal we will conduct all tasks required to generate the final Pharmacology/Toxicology, Chemistry Manufacturing and Controls (CMC) information required for IND submission of a vaginal contraceptive gel. 1) The current formula will be modified by Dr. Sanjay Garg to increase viscosity and mucoadhesion. We call this drug product Yaso-CON. The newly formulated Yaso-CON, appropriate for vaginal application will be transferred to our manufacturing partner who will scale up the product under cGMP, producing clinical trial samples, stability study samples and additional lots of drug product for final preclinical toxicology studies. 2) We will evaluate two lab assays developed by the inventors and one commercial assay for future use as a biomarker in Phase 1 clinical trials. We would like to have an assay that can guide us in determining final concentration of the active drug, rather than depending on pregnancy in women to give us that answer. If our research under this grant is fruitful, we will have an assay to determine contraceptive activity of post-coital vaginal secretions collected from women in Phase 1. This will guide our Phase 2 dose range finding study and final formulation. 3) A rabbit contraceptive study and GLP preclinical toxicology studies will be completed at appropriate CROs. 4) Phase 1 and 2 clinical trials will be developed. Feedback on these trials from FDA will be sought. An IND will be prepared and submitted. At the conclusion of this grant work we will have an active IND with clinical trial samples, ready to conduct Phase 1 human clinical trials.