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INOVIO Reports Positive Interim Phase 2 VGX-3100 Results In Patients with HPV-associated Anal Dysplasia
- VGX-3100 DNA medicine cleared high-risk HPV 16/18-associated precancerous lesions in 50% of patients, and reduced the number of lesions in 75% of patients -
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"- VGX-3100 DNA medicine cleared high-risk HPV 16/18-associated precancerous lesions in 50% of patients, and reduced the number of lesions in 75% 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 26, 2020 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) today announced positive interim results from an open-label, Phase 2 study showing its lead DNA medicine candidate VGX-3100 to be safe and effective in treating men and women with anal dysplasia, also known as high grade squamous intraepithelial lesion (HSIL), a precancerous condition caused by high-risk human papillomavirus (HPV) types 16/18. Of the 20 subjects who had results at the time of data review, 50% (10 of 20 subjects) showed clearance of HPV-16/18 associated precancerous lesions and 75% (15 of 20 subjects) demonstrated an overall decrease in the number of lesions 6 months after the start of treatment. No cases of anal cancer have been observed in the trial. The results support the ability of VGX-3100 to effectively treat multiple HPV associated diseases and will be presented in the virtual session of the annual American Society for Colposcopy and Cervical Pathology (ASCCP) meeting titled: Preliminary Results of an Open-label Phase 2 Study of VGX-3100 for the Treatment of HPV16 and/or HPV-18 (HPV16/18) related Anal HSIL.\nAnal dysplasia or anal HSIL, is an orphan disease that affects men and women in both immunocompetent and immunocompromised populations. Fewer than 1 in 5 people with HPV 16/18-associated precancerous dysplasia exhibit spontaneous resolution at one year. Without adequate treatment anal HSIL could progress to anal cancer. HPV 16/18 cause more than 90% of all anal cancer, which is now considered one the most rapidly rising causes of cancer incidence and mortality. According to the American Cancer Society, anal cancer will claim the lives of more than 1,300 people in the U.S. and 8,590 news cases (5,900 in women and 2,690 in men) will be diagnosed in 2020 and according to a study published November 2019 in the Journal of the National Cancer Institute, from 2001 to 2015 the overall incidence of anal cancer increased by 2.7% per year and mortality jumped by 3.1% each year\nPrakash Bhuyan, M.D., Ph.D., INOVIO's Vice President and Head of HPV Therap...