(RTTNews) - Inovio Pharmaceuticals Inc. (INO) on Wednesday announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia.
The company said that a reduction of 25 percent or more in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63 percent, or 12 of 19 trial participants treated with VGX-3100 at six months post-treatment.
Three out of the twenty participants with histology data, or 15 percent, 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 percent. The trial also showed VGX-3100 to be safe and well-tolerated, the company noted.
INOVIO said that based upon these results, it plans to pursue Phase 3 development of VGX-3100.
VGX-3100 is a DNA medicine in clinical trials for the treatment of three HPV-16/18 related disease states - anal dysplasia, vulvar dysplasia and cervical dysplasia.
Vulvar dysplasia is a rare disease that affects women in immunocompetent and immunocompromised populations. Less than 2 percent of women with HPV-16/18-associated precancerous vulvar dysplasia exhibit spontaneous resolution.
HPV-16/18-associated precancerous vulvar lesions, or vulvar HSIL, are known to be difficult to treat, and typically require repeat ablation and excision procedures to achieve disease and risk reduction.
Vulvar HSIL can progress to vulvar cancer without adequate treatment. In 2017, vulvar cancer was diagnosed in 1354 women in the U.S. and 411 died from vaginal cancer.
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