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Inovio Completes Enrollment of VGX-3100 Phase 2 Trial for the Treatment of HPV-Related Vulvar Dysplasia (VIN)
Biotech company will report interim data later this year PLYMOUTH MEETING, Pennsylvania, July 8, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc.
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Biotech company will report interim data later this year\n PLYMOUTH MEETING, Pennsylvania, July 8, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has completed enrollment in its Phase 2 trial with VGX-3100 in patients with precancerous lesions of the vulva or vulvar intraepithelial neoplasia (VIN). VGX-3100 is an immunotherapy that targets human papillomavirus (HPV) 16 and 18 and is being studied for the treatment of HPV-related precancerous lesions and the HPV infection that causes these lesions. Inovio is already evaluating VGX-3100 in two Phase 3 registration trials (REVEAL 1 and REVEAL 2) to treat cervical dysplasia caused by HPV.\nThis randomized, open-label Phase 2 study will assess the efficacy of VGX-3100 in 33 women with high-grade HPV-related vulvar lesions. The immunotherapy is administered with Inovio's CELLECTRA® device. The primary endpoint of the study is histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate safety and tolerability of VGX-3100. The company intends to report interim clinical data from this study before year's end. \nDr. Prakash Bhuyan, MD PhD, VP, Clinical Development and the Lead for the VGX-3100 Program, said, \"Inovio is developing VGX-3100 to be the first, comprehensive non-surgical treatment option for HPV-related precancer. Surgical treatment of VIN is often disfiguring, and recurrence occurs in approximately one third of women. The enrollment of our US-based Phase 2 study of VIN exemplifies the outstanding commitment of our Investigators and their patients to making it possible to improve the current standard of care for VIN and ultimately reduce the occurrence of vulvar cancer.\" \nVIN has a very low rate of spontaneous, or natural, regression − below 5%. Currently there are no FDA-approved non-surgical treatments for precancerous lesions of the vulva. Surgery, the most common treatment, is associated with high rates of disease recurrence and can cause disfigurement, long-term pain, and psychological distress for the women who undergo the procedure. VIN recurs in approximately one of every two patients who undergo surgical treatment.\nInovio's immunotherapy aims to address the unmet medical need for VIN by providing a non-surgical option for women with this disease. I...