REVEAL 1 Cervical Cancer Study Ready to Launch

The pivotal Phase 3 clinical trial "REVEAL 1" of the VGX-3100 vaccine, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV), has completed patient enrollment. 

If approved, the VGX-3100 vaccine candidate would be the first immunotherapy and non-surgical alternative for women with late-stage cervical dysplasia. 

VGX-3100 is under investigation for the treatment of HPV 16 and HPV 18 infection and pre-cancerous lesions of the cervix and vulva and anus.   

VGX-3100 works by stimulating a specific immune response to HPV 16 and HPV 18, which targets the infection and causes destruction of pre-cancerous cells. 

This study is important since untreated cervical dysplasia can progress to cervical cancer.   

Inovio Pharmaceutical's Phase 3 program is assessing the efficacy of VGX-3100 to regress cervical high-grade squamous intraepithelial lesions (HSIL), a direct precursor to cervical cancer, and to eliminate 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. 

REVEAL 1 is designed to provide a one-year safety data for a minimum of 198 patients on VGX-3100.   

A confirmatory Phase 3 trial (REVEAL 2) is currently enrolling and is designed to provide a one-month safety data for a minimum of 198 patients.

The primary endpoint of this Phase 3 study is the regression of cervical HSIL and virologic clearance of HPV 16 and/or HPV 18 in the cervix. 

Dr. Prakash Bhuyan, M.D., Ph.D, Clinical Development lead for VGX-3100, said in a press release, "The completion of REVEAL 1 enrollment is a testament to the dedication of our outstanding investigators and their teams, who span 19 countries – a true global effort – to develop a non-surgical treatment for cervical high-grade dysplasia." 

Inovio previously reported that VGX-3100 eliminated high-grade dysplasia in almost 50 percent of women in its Phase 2b randomized, placebo-controlled trial.   

In 80 percent of the women whose high-grade dysplasia was eliminated, the HPV infection was also cleared by VGX-3100.   

Further data analysis revealed that the combination of HPV detection and cervical cytology (Pap smear) following dosing was predictive early during the treatment period for both eliminations of the high-grade dysplasia and clearance of HPV. 

In addition, Inovio continues to pursue the development of pre-treatment biomarker tests in collaboration with QIAGEN that may provide the ability to predict clinical response to VGX-3100, ultimately aiding in patient selection and physician guidance of patient care.   

These pre-treatment biomarkers could identify patients most likely to respond to treatment with VGX-3100, increasing the absolute efficacy of the product. 

Previous news:

• VGX-3100 Named Best Therapeutic Vaccine Candidate for HPV
• Cervical Cancer HPV Vaccine Candidate Launches Phase 3 Study

Cancer often takes years, even decades, to develop after a person gets HPV. CDC recommends HPV vaccination at ages 11-12 to protect against these cancers, says the Centers for Disease Control and Prevention (CDC). 

There is no way to know which people who have HPV will develop cancer or other health problems.   

People with weakened immune systems may be less able to fight off HPV and more likely to develop health problems from it. 

The Gardasil 9 vaccine is the only HPV vaccine approved in the USA and helps protect girls and women ages 9 to 45 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by HPV viruses. 

Additionally, Gardasil 9 helps protect boys and men ages 9 to 45 against anal cancer and genital warts caused by those same HPV types.

Gardasil 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV.

Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases.