Preparation and submission of an IND for PPCM Gel contraceptive
Preparation and submission of an IND for PPCM Gel contraceptive
批准号:
10483274
负责人:
Mary B Weitzel
金额:
$29.85万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-04-06 至 2023-03-31
关键词:
AIDS preventionAnti-Infective AgentsBindingBiological AssayBiological MarkersClinical TrialsCollaborationsConsultContraceptive AgentsContraceptive methodsEconomicsFemaleFertilizationGelGlycosaminoglycansGrantGuidelinesHIVHyaluronanIndividualNational Institute of Allergy and Infectious DiseaseNational Institute of Child Health and Human DevelopmentNeisseria gonorrhoeaeNo-Observed-Adverse-Effect LevelOral AdministrationOryctolagus cuniculusPamphletsPersonsPharmacologic SubstancePhasePhase I Clinical TrialsPreclinical TestingPreparationPrevalencePreventionProtocols documentationRattusReproductive HealthResearch PersonnelSafetySexually Transmitted DiseasesSimplexvirusSmall Business Innovation Research GrantSodiumSodium ChlorideTechnologyTherapeuticToxicologyUniversitiesVaginaVaginal GelVaginal Route of Drug AdministrationViralViral Sexually Transmitted DiseasesWomanWritingantimicrobialarmeffectiveness testingexternal genitaliafirst-in-humanmalemeetingsmennovelpenispreclinical evaluationpreclinical studyprematureresearch and developmentresearch clinical testingsocialsperm cellsperm qualityunintended pregnancy
中文摘要
项目总结
英文摘要
PROJECT SUMMARY
Polyphenylene carboxymethylene sodium salt (PPCM) is being developed by Yaso Therapeutics as a
woman-controlled, on-demand vaginal contraceptive gel (PPCM-GEL) with a unique, non-cytotoxic mechanism
that triggers premature acrosomal loss of sperm, rendering them incapable of fertilization. Since PPCM also
binds highly conserved glycosaminoglycans, this novel gel has additional potential to function as a
multipurpose prevention technology (MPT) that protects against important bacterial and viral sexually
transmitted infections (STIs). Under this grant we propose to complete one last packaging compatibility and
stability study of PPCM-GEL, complete writing the IND per eCTD and FDA guidelines, and have a regulatory
consulting firm electronically submit the IND to FDA.
With the support of prior NIAID and NICHD grants (R42AI069659, R43/44AI084225,5R44HD092206), we have
advanced PPCM through preclinical evaluation and have successfully formulated a mucoadhesive, non-
irritating vaginal gel that is ready for clinical evaluation. The mechanism of action on sperm has enabled us to
conduct pre-clinical studies using a commercially available sperm quality biomarker, hyaluronan binding assay
(HBA®) to assess potential contraceptive activity. In pre-clinical testing, we have also demonstrated potent
activity against Neisseria gonorrhoeae, herpes simplex virus, and HIV. PPCM-GEL is formulated for non-
systemic topical use, is non-hormonal, and has potential to be one of the first successful MPT products with
contraceptive and broad STI/HIV prevention efficacies. The prevalence of unplanned pregnancy and STIs
among women in all economic, social, and cultural circumstances has remained high despite existing
prevention options. There is a long-standing paucity of available on-demand and nonhormonal broad-spectrum
prevention options. Availability of a dual-purpose product for contraception and STI/HIV prevention will arm
people with an important option for reproductive health.
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