Preclinical development of PPCM vaginal contraceptive to submit IND.

PROJECT SUMMARYThe goal of this project is to develop a novel vaginal contraceptive gel product containing PPCM sodium saltPPCMPPCM is a novel polymer drug that inhibits infection of HSVHIVNgonorrhea and is also contraceptiveThis novel drug has an average molecular weight ofis designed to be used topicallyand thus far passed all safety studies and does not appear to be systemically absorbedPPCM has been the subject of several publicationsDevelopment of a topical gel containing PPCM as a preventive and treatment product for genital herpes has been funded through three earlier STTR SBIR grantsWe have taken the drug from the bench to a defined drug with a full suite of analytical methodsa defined manufacturing method with a C of A and Reference Standard Batchconducted two forced degradation studiesnumerous formulations and numerous animal safety and efficacy studiesUnder this grant proposal we will conduct all tasks required to generate the final Pharmacology ToxicologyChemistry Manufacturing and ControlsCMCinformation required for IND submission of a vaginal contraceptive gelThe current formula will be modified by DrSanjay Garg to increase viscosity and mucoadhesionWe call this drug product Yaso CONThe newly formulated Yaso CONappropriate for vaginal application will be transferred to our manufacturing partner who will scale up the product under cGMPproducing clinical trial samplesstability study samples and additional lots of drug product for final preclinical toxicology studiesWe will evaluate two lab assays developed by the inventors and one commercial assay for future use as a biomarker in Phaseclinical trialsWe would like to have an assay that can guide us in determining final concentration of the active drugrather than depending on pregnancy in women to give us that answerIf our research under this grant is fruitfulwe will have an assay to determine contraceptive activity of post coital vaginal secretions collected from women in PhaseThis will guide our Phasedose range finding study and final formulationA rabbit contraceptive study and GLP preclinical toxicology studies will be completed at appropriate CROsPhaseandclinical trials will be developedFeedback on these trials from FDA will be soughtAn IND will be prepared and submittedAt the conclusion of this grant work we will have an active IND with clinical trial samplesready to conduct Phasehuman clinical trials