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INOVIO Interim Results of an Open-Label Phase 2 Trial of VGX-3100 Show Efficacy Against HPV-associated Vulvar Dysplasia
- VGX-3100 DNA medicine reduced qualifying high-risk HPV 16/18-associated precancerous vulvar lesion area in 80% of patients (by 60% on average); completely
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"- VGX-3100 DNA medicine reduced qualifying high-risk HPV 16/18-associated precancerous vulvar lesion area in 80% of patients (by 60% on average); completely curing vulvar dysplasia with no virus detectable in 20% of patients\n - Data to be presented at the 2020 American Society for Colposcopy and Cervical Pathology (ASCCP) meeting\n\n\nPLYMOUTH MEETING, Pa., March 30, 2020 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) today reported interim results from an open-label Phase 2 trial designed to evaluate the safety and efficacy of VGX-3100 in women with vulvar dysplasia, also known as high grade squamous intraepithelial lesion (HSIL), a precancerous condition caused by high-risk human papillomavirus (HPV) types 16 and/or 18. A total of 22 subjects have received all 4 doses and will be evaluated to the end of the study. INOVIO is reporting interim data on the 10 subjects who have completed their primary endpoint evaluation at six months following treatment with VGX-3100. Based upon the available results, 80% (8 out of 10 subjects) had a reduction (2 cm2 on average) in qualifying lesion area (average 60% reduction) of which 20% (2 of 10) completely resolved their vulvar HSIL and had no virus detectable in the healed area, 6 months following treatment. \nTrial results will be presented from April 1st through April 2nd at the annual American Society for Colposcopy and Cervical Pathology (ASCCP) meeting as a virtual session titled: \"Preliminary Results of an Open-Label Phase 2 Study of VGX-3100 for the Treatment of HPV-16 and/or HPV-18 (HPV-16/18) Related Vulvar HSIL.\" Safety results were consistent with the known safety profile of VGX-3100. There were no drug-related serious adverse events. No cases of carcinoma have been observed.\nVulvar HSIL is an orphan condition that usually requires surgery, which has significant physical and psychosocial impacts (e.g. severe pain, disfigurement, sexual dysfunction). The success of such surgery is marginal, as the recurrence rate of high grade vulvar pre-cancer is approximately 30 to 50% three years post-treatment. Overall less than 5% of women with vulvar HSIL exhibit spontaneous resolution. Without adequate treatment vulvar HSIL can progress to vulvar cancer which is projected to claim approximately 1350 lives in the US in 2020 alone.\nDr. Prakash Bhuyan, MD PhD, Vice President a...