INOVIO announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia. A 25% or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based upon these results INOVIO is planning to pursue Phase 3 development. VGX-3100 Phase 2 Vulvar Dysplasia Trial Highlights: Trial participants were 24 women between 22 and 70 years of age at entry and other than having HSIL were healthy; 80% (20/25) had VIN3 disease (the more severe form of VIN) and 88% (22/25) had a history of 1 or more recurrences; There were no discontinuations due to adverse events; five participants elected to withdraw for reasons unrelated to adverse events; 19 participants had digital photography data, and 12 (63%) had clinically significant lesion reduction as defined by a reduction of lesion area of more than 25%; 20 participants had histology and virology data and 3 (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area; Histology was assessed by up to two independent pathologists and non-detectability of HPV-16/18 from lesion tissue using PCR (polymerase chain reaction)-based testing, at six months following the administration of VGX-3100; Efficacy endpoints were measured six months post-treatment; Safety will continue to be assessed for 18 months following the last dose; The most observed adverse event was injection site pain, the majority of which were mild-to-moderate; No cases of vulvar cancer have been observed in the trial.