Inovio Pharmaceuticals has initiated its Phase III REVEAL clinical programme of VGX-3100 for the treatment of cervical dysplasia associated with human papillomavirus (HPV), following a clinical hold removal by the US Food and Drug Administration (FDA).
VGX-3100 is a DNA-based immunotherapy that induces a specific immune response to HPV-16 and HPV-18 for targeting the infection and killing pre-cancerous cells.
Inovio is said to have provided the required information on its CELLECTRA 5PSP delivery device to FDA, leading to the removal of hold on the Phase III programme.
The firm plans to immediately commence the enrolment of patients for the trial, which will evaluate the efficacy of VGX-3100 in regressing cervical high-grade squamous intraepithelial lesions (HSIL) and eliminating the HPV infection.
The REVEAL programme is designed to simultaneously conduct a primary REVEAL 1 trial and confirmatory REVEAL 2 trial.
The prospective, randomised, double-blind, placebo-controlled REVEAL trial will recruit 198 patients each at up to 100 centres.
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Subjects with HPV 16/18 positive biopsy-proven cervical HSIL, also known as cervical intraepithelial neoplasia (CIN) 2 or 3, will be included in the programme.
Inovio chief medical officer Dr Mark Bagarazzi 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.”
The primary endpoint of the trials is regression of cervical HSIL and virologic clearance of HPV-16 and / or HPV-18 in the cervix, while secondary endpoints include safety, tolerability, efficacy, regression of CIN 2/3, virologic clearance of HPV and clearance of HPV from non-cervical anatomic locations.
The cervical tissue changes will also be assessed following a three-dose regimen of VGX-3100 given at zero, one, and three months.