Inovio, AIDS Malignancy Consortium partner to evaluate VGX-3100
Inovio Pharmaceuticals announced that it has entered into a partnership with the AIDS Malignancy Consortium to evaluate VGX-3100, Inovio's immunotherapy for treating HPV-associated precancerous conditions in HIV-positive adult men and women. AMC will fund a Phase 2 clinical trial to evaluate the efficacy of VGX-3100 in adult men and women with human papillomavirus-related high-grade anal dysplasia or squamous intraepithelial lesions and HIV. Recruitment is already ongoing for patients who are HIV-positive with histologically confirmed anal high-grade squamous intraepithelial lesions associated with HPV-16 and/or HPV-18. The multi-site Phase 2 study is planning to enroll approximately 75 patients who will receive four doses of VGX-3100. Financial details of the agreement were not disclosed. This open-label, multi-center Phase 2 study is designed to evaluate the safety and efficacy of VGX-3100 administered by intramuscular injection with CELLECTRA delivery system in adult men and women who are HIV-positive with anal HSIL associated with HPV-16 and/or HPV-18. Separately, Inovio has already initiated a multi-center Phase 2 study designed to evaluate the safety and efficacy of VGX-3100 in 24 HIV-negative patients with anal HSIL associated with HPV-16 and/or HPV-18. The first patient was dosed in July.