There are no known treatments for HPV (human papillomavirus) infection that causes cervical dysplasia, producing cervical High-Grade Squamous Intraepithelial Lesions (HSIL). Although, with the help of surgery, HSIL can be removed, but it does not kill the HPV infection way underneath. It can cause cervical incompetence and birth before time. Consequently, it can lead to fetal morbidity and mortality. If not treated timely, this condition can even progress into cervical cancer. In fact, the underline cause of this cancer is HPV infection.
Seventy percent of cervical cancers are caused by HPV-16 and HPV-18. Each year more than 400,000 new HPV-16/18 cases come forth in the US and Europe, according to the National Cancer Institute.
However, a new DNA-based immunotherapy has been produced by Inovio Pharmaceuticals, who are going to test its efficacy with their REVEAL study program. REVEAL stands for Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL. The effectiveness of VGX-3100 on the grounds of regressing cervical HSIL as well as removal of HPV infection is going to be analyzed by the researchers.
The REVEAL studies are randomized, placebo-controlled, double-blind and prospective trials. Adult women who have HPV-16/18 and cervical HSIL proved positive through biopsy are going to be evaluated in the study. The endpoint of the study is the confirmation of the elimination of both the cervical lesions and HPV infection. If so, VGX-3100 would prove to be the first non-surgical treatment for HSIL and first-ever treatment for HPV.
VGX-3100 has the ability to initiate a particular immune response to HPV-16/18 that can target the infection and kill any cancer-causing cells. In the phase 2b study, VGX-3100 demonstrated this ability.
Inovio’s Chief Medical Officer, Dr. Mark Bagarazzi, terms VGX-3100 as “first-in-class HPV-specific immunotherapy” which can be a better alternative to an invasive surgical procedure that can tarnish the reproductive health of women. With further investigation, hopefully, cervical cancer would be prevented at the best possible level.