Presented by: Tom McCarthy. Starpharma Pty Limited, Melbourne, VIC, Australia.

Genital herpes caused by herpes simplex virus type 2 (HSV-2) is one of the most common sexually transmitted infections. In the USA, one in five teenagers and adults is infected with HSV-2, while one in four women are infected. Genital herpes is characterized by high rates of clinical and subclinical reactivation in the genital mucosa and the associated risk of sexual transmission. While genital herpes is a significant global epidemic, the link between genital herpes infection and HIV acquisition is also now indisputable. For example, a meta-analysis of the risk of HIV infection in HSV-2-seropositive persons showed that HSV-2 infection is a significant risk factor for HIV acquisition. This association between HSV-2 and HIV acquisition drove the antiviral drug discovery programme at Starpharma to identify dendrimers that inhibited both HIV and HSV-2 viral entry. This work has culminated in the clinical development of SPL7013 Gel (VivaGel™) as a microbicide intended to prevent the sexual transmission of both HSV-2 and HIV to women under individual Investigational New Drug applications with the US Food and Drug Administration. This presentation will discuss key nonclinical and clinical data for VivaGel™ under this development program.