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INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Vulvar Dysplasia Caused by HPV-16/18
- DNA immunotherapy candidate VGX-3100 demonstrated clinically significant reduction of HPV-16/18-associated precancerous vulvar lesions in 63% of treated
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"- DNA immunotherapy candidate VGX-3100 demonstrated clinically significant reduction of HPV-16/18-associated precancerous vulvar lesions in 63% of treated participants six months after treatment\n - Phase 2 results indicate that VGX-3100 can be a safe, tolerable and efficacious adjunct to current standard of care for women with vulvar dysplasia\n - Phase 3 trial planned in 2021\n\n\nPLYMOUTH MEETING, Pa., Jan. 6, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer and HPV-associated diseases, today announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia. A 25% or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based upon these results INOVIO is planning to pursue Phase 3 development.\nDr. Robert Edwards, MD, Milton Lawrence McCall Professor and Chair, Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh and Principal Coordinating Investigator for the Phase 2 clinical trial said, \"These Phase 2 efficacy results are a very promising non-surgical advance for a recalcitrant disease that normally requires repetitive ablation and excision procedures to achieve disease and risk reduction, and may offer a more safe, tolerable and efficacious treatment option for patients.\"\nPrakash Bhuyan, M.D., Ph.D., Senior Vice President and Head of HPV Therapeutic Clinical Development at INOVIO, said, \"The reduction of precancerous disease offers a meaningful improvement in the management of this devastating disease and is a step forward towards the enhancement of women's healthcare.\"\nVGX-3100 Phase 2 Vulvar Dysplasia Trial Highlights\nTrial participants were 24 women between 22 and 70 years of age at entry and other than having HSIL were hea...