Inovio Pharmaceuticals has started a Phase ll clinical trial designed to assess the safety and efficacy of VGX-3100 for the treatment of adult men and women with human papilloma virus (HPV)-related anal dysplasia.
The open-label, multi-centre trial aims to enrol about 24 patients who are HIV-negative with histologically confirmed anal or perianal high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 and/or HPV-18.
Inovio has already started enrolling patients for the trial.
As part of the study, at least three doses of VGX-3100 will be administered to patients through intramuscular (IM) injection w CELLECTRA delivery system.
The Phase ll trial coordinating principal investigator Dr Céline Bouchard said: “The large burden of disease rests in the general population.
“As more than 70% of anal cancers in the United States occur among HIV-negative men and women, a non-surgical immunotherapy to eradicate precancerous perianal and/or anal lesions caused by HPV types 16 or 18 infection would represent a major breakthrough for the treatment of this disease and the prevention of anal cancer.”
Anal HSIL or dysplasia is the precursor to anal cancer, which so far this year has estimated to cause more than 1,100 deaths in the US.
The only treatments available for anal dysplasia include surgical excision, electro-cautery or laser therapy, but more than 50% of the patients treated with these current treatments experience recurrence of the disease.
VGX-3100, which is an investigational DNA-based immunotherapy, has the potential to be used as an approved treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions.