Cervical Cancer HPV Vaccine Candidate Launches Phase 3 Study

A new immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV) has launched a phase 3 clinical study.

Inovio Pharmaceuticals, Inc. announced that it has commenced its REVEAL (Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) study to evaluate the efficacy of its DNA-based immunotherapy, VGX-3100.

This study is important since there are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL.

While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries an increased risk of cervical incompetence and pre-term birth, which can result in fetal morbidity and mortality.

Left untreated, women diagnosed with cervical HSIL are at an increased risk of developing cervical cancer.

HPV types 16 and 18 are responsible for 70% of cervical cancers, with more than 400,000 new cases of HPV 16/18 cervical HSIL annually in the US and Europe, says the National Cancer Institute. 

Inovio’s study will assess the efficacy of VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions.

The REVEAL studies are prospective, randomized (2:1), double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3.

The primary endpoint is a regression of cervical HSIL AND virologic clearance of HPV-16 and/or HPV-18 in the cervix.

VGX-3100 has the potential to be the first treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions.

VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells.

VGX-3100 demonstrated in a phase 2b study its ability to clear HPV-16 and HPV-18 infection and pre-cancerous lesions.

Dr. Mark Bagarazzi, Inovio’s Chief Medical Officer, said, “VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health.”

For more information, visit www.inovio.com.