Inovio Pharmaceuticals has commenced the phase 3 clinical program to evaluate the efficacy of its DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV).
The 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 data will support the potential licensure of VGX-3100 as the first immunotherapy for this disease.
Inovio satisfied the FDA’s request for information relating to its CELLECTRA 5PSP delivery device, resulting in Administration removing the clinical hold on this program. Inovio plans to immediately begin recruiting patients for the phase 3 trial.
The phase 3 program – named REVEAL (Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) – will consist of a primary study (REVEAL 1) and confirmatory study (REVEAL 2), as per FDA general guidance for phase 3 programs, to be conducted in parallel.
The studies will each enroll 198 patients in more than 100 study centres globally. Mark Einstein, MD, MS, FACS, FACOG, Professor and Chair Department of Obstetrics, Gynecology and Women’s Health Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, is Principal Investigator for the studies.
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.
It stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells.
There are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL.