Precancerous Vulvar Dysplasia (HSIL)

Stage (next event)

Expected Date

Phase 2 (Data)

Q4 2020

Catalyst Info & Data Links

TITLE: VGX-3100 for Precancerous Vulvar Dysplasia (HSIL) - Phase 2 Data

  • (NCT03180684): Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)


  • Phase 2 Data




Mechanism of Action


  • VGX-3100 is a DNA medicine under Phase 3 investigation for the treatment of HPV-16 and HPV-18 infection and precancerous lesions of the cervix. INOVIO is in open-label Phase 2 clinical trials evaluating its efficacy for treating HPV-related vulvar and anal dysplasia (HSIL). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions. It works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of precancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical dysplasia (CIN2/3 or HSIL), treatment with VGX-3100 resulted in a statistically significantly greater regression of cervical dysplasia and clearance of HPV-16/18 infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient's own immune system to clear HPV-16 and HPV-18 infection and precancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.


  • If left untreated vulvar pre-cancers can progress to invasive cancer of the vulva. Approximately 27,000 cases of HPV-related vulvar pre-cancers occur in the U.S. each year with a similar number of estimated cases in Europe each year. HPV-16 and/or HPV-18 are involved in about 80% of HPV-related vulvar pre-cancers cases in the U.S. and Europe. Once vulvar pre-cancers develop, spontaneous regression (i.e. natural resolution of the lesion) is rare and occurs in 1.5% to 5% of cases. An estimated 6,000 new cases of vulvar cancer occur in the U.S. each year with about 50% to 80% of those being HPV-associated.

Updated by HC

Prior Data (click to view full image)


Trial Design / Revenue (click to view full image)


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