INOVIO has reported that Phase III REVEAL 1 trial of DNA medicine, VGX-3100, to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), met the primary and secondary endpoints in all evaluable subjects.
A pre-cancerous condition of the cervix, Cervical HSIL directly precedes invasive cervical cancer development.
This trial is one among the two ongoing pivotal, randomised, double-blind, multi-centre, placebo-controlled Phase III trials (REVEAL 1 and REVEAL 2).
It is analysing the safety, tolerability and efficacy of VGX-3100 for treating HPV-16/18-associated cervical HSIL using the CELLECTRA 5PSP device.
The REVEAL 1 trial enrolled 201 adult women with histologically confirmed cervical HSIL linked to HPV-16 and/or HPV-18, but who were otherwise healthy. They were randomised into a 2:1 ration to receive either VGX-3100 or placebo at zero, four, and 12 weeks.
At week 36, 23.7% of subjects in the treatment arm achieved statistically significant histopathological regression of HSIL combined with virologic clearance of HPV-16 and/or HPV-18 versus 11.3% in the placebo arm, thereby meeting the primary endpoint.
The trial also met all secondary efficacy endpoints: regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, regression of cervical HSIL alone, regression of cervical HSIL to normal tissue, and HPV-16/18 viral clearance alone.
Treatment-related serious adverse events were not observed in the trial.
INOVIO president and CEO Dr J Joseph Kim said: “INOVIO is very proud to advance VGX-3100 as the first DNA medicine to achieve efficacy endpoints in a Phase III clinical trial in all evaluable subjects.
“We expect VGX-3100, if approved, to be an important therapeutic option for those impacted by HPV-16-/18-related disease.
“The REVEAL 1 efficacy and safety data also represent an important proof-of-platform for INOVIO’s DNA medicines.”
The company will continue to follow up with the trial participants for safety and durability of response for 18 months following the last administration.
Along with Qiagen, INOVIO is working on developing a pre-treatment RNA-based biomarker blood test to detect women likely to respond to VGX-3100.