The increasing incidence of sexually transmitted diseases (STDs) and women's needs to protect their reproductive health are impetus for development of novel methods of STD prophylaxis. Peptidyl Membrane Interactive Molecules (Peptidyl MIMsTM) from Demeter BioTechnologies, Ltd. are unique peptide antibiotics that kill STD pathogens in vitro at low concentration, while demonstrating minimal intravaginal irritation or systemic toxicity in animal models. Phase I studies will develop gel formulations for intravaginal administration with Demeter's two lead anti-STD compounds. Formulated gels will be tested against gonorrhea and trichomoniasis in in vitro assays. These microbicides will then be tested intravaginally in murine animal models to determine their ability to interrupt gonorrhea and trichomoniasis transmission, without causing significant irritation or toxicity within the vagina. Histopathologic examinations will be conducted to determine local and systemic effects of drugs and disease progress in the animal models. Upon demonstration of significant reduction in STD transmission in the animal models, Phase II studies will be sought to conduct the necessary tests to apply for an Investigational New Drug with the United States Food and Drug Administration (FDA). Human clinical studies would follow.
