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Inovio Completes Enrollment of VGX-3100 Phase 3 Trial (REVEAL 1) for the Treatment of HPV-Related Cervical Pre-cancer
PLYMOUTH MEETING, Pa., June 26, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the completion of target enrollment of 198
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"PLYMOUTH MEETING, Pa., June 26, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the completion of target enrollment of 198 participants for its pivotal Phase 3 registration trial (\"REVEAL 1\") of VGX-3100, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV). Left untreated, cervical dysplasia can progress to cervical cancer. If approved, VGX-3100 would be the first immunotherapy and non-surgical alternative for women with late-stage cervical dysplasia. \nDr. J. Joseph Kim, Inovio's President & CEO, said, \"This establishes an important milestone for the company as it brings Inovio another step closer to providing an innovative treatment alternative to the women suffering with cervical dysplasia for whom surgery is the only option today. Both the U.S. and Europe represent large markets in need of a non-invasive treatment option for women, and we're now focused on enrolling the confirmatory study (REVEAL 2) to generate a U.S. FDA submission in 2021.\"\nInovio's Phase 3 program is assessing the efficacy of VGX-3100 to regress cervical HSIL (high-grade squamous intraepithelial lesions), 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.\nThe primary endpoint of the Phase 3 study is regression of cervical HSIL and virologic clearance of HPV 16 and/or HPV 18 in the cervix. The studies will evaluate cervical tissue changes at approximately 9 months after beginning a three dose regimen of VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic clearance of HPV; efficacy measured by non-progression to cancer; and clearance of HPV from non-cervical anatomic locations. \nDr. Prakash Bhuyan, MD PhD, Clinical Development lead for VGX-3100...