Phase II efficacy study on-going
Inovio continues patient recruitment for its phase II study of VGX-3100, which is designed to enroll 148 patients with cervical dysplasia at multiple study centers. This randomized, double-blinded, placebo-controlled study will assess regression of cervical lesions from CIN 2/3 or CIN 3 to CIN 1 or complete regression of the lesions. The secondary endpoint is to assess the clearance of HPV 16 or 18. Subjects will also be monitored for tolerability and safety. Inovio expects results from this trial late next year. See the HPV-003 clinical trial
About Cervical Dysplasias/Cancers
Human papillomavirus (HPV) is the causative agent responsible for most cases of cervical cancer. At any given time, approximately 10% of women worldwide are infected with HPV. While roughly 70% of HPV infections are cleared by the body on its own, persistent HPV can lead to dysplasia, or premalignant changes in cells, of the cervix. Researchers have estimated the global prevalence of clinically pre-cancerous HPV infections at between 28 and 40 million. Persistent dysplasias may then progress to cancer. Every year, 510,000 cases of cervical cancer are diagnosed worldwide, and about 288,000 of the afflicted women die.
Preventive vaccines such as GARDASIL® and CERVARIX® are playing an important role in limiting new HPV infections. However, preventive vaccines cannot provide protection for those already infected, which is a large population. In addition, a significant number of the girls and women eligible to be vaccinated are not receiving these preventive vaccines. There is no viable therapeutic vaccine or drug to treat HPV, nor dysplasias and cancers caused by HPV. Current ablative or surgical procedures to remove cervical dysplasias and cancers are unappealing due to their potential for disfigurement, the perceived negative impacts on childbirth, and the stress of the watch-and-wait approach that typically precedes these procedures.