DNA Medicine Found Effective Against HPV 16/18 Cancers

INOVIO VGX-3100 found safe and effective in treating men and women with anal dysplasia
couple kissing

A Pennsylvania based pharmaceutical company announced positive interim results from a Phase 2 clinical study showing its 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).

HSIL a precancerous condition caused by high-risk, human papillomavirus (HPV) types 16/18, which affects men and women in both immunocompetent and immunocompromised populations.

HPV 16/18 causes more than 90 percent of all anal cancer, which is now considered one of the most rapidly rising causes of cancer incidence and mortality, according to the American Cancer Society.

Announced in a press release on March 26, 2020, Inovio Pharmaceuticals’ study included 20 subjects who had results at the time of data review, 50 percent (10 of 20 subjects) showed clearance of HPV-16/18 associated precancerous lesions and 75 percent (15 of 20 subjects) demonstrated an overall decrease in the number of lesions 6 months after the start of treatment. 

This study’s results support the ability of VGX-3100 to effectively treat multiple HPV associated diseases.

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.

And, 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. 

Prakash Bhuyan, M.D., Ph.D., Inovio's Vice President and Head of HPV Therapeutic Clinical Development said in the press release, "These initial proof-of-concept efficacy results show that VGX-3100 has the potential to enable the immune system to clear HPV 16/18 HSIL that cause precancerous anal dysplasia.”

Currently, the treatments for anal dysplasia are surgical excision, electro-cautery or laser therapy. 

Up to 50 percent of those treated with these invasive options experience disease recurrence within one year of treatment and nearly 70 percent experience recurrence within 3-years. 

Therefore, many patients with this condition need multiple invasive treatments.

Dr. Céline Bouchard, Gynecologist/ Anoscopist at Centre Médical Santé Femme in Québec City, Canada, and Coordinating Principal Investigator for the study, said in a press release "Having a DNA medicine that can destroy and clear lesions without the burden of repetitive, multiple, and painful surgical or invasive treatments would change the standard of care and provide patients with a meaningful benefit.”

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases associated with HPV, cancer, and infectious diseases.

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