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Immunotherapy that significantly impacts the clinical status of advanced cervical
intraepithelial neoplasia (CIN) has the potential to provide physicians an important
alternative to surgery to treat CIN 2/3 disease. Our previous two Phase I studies
of VGX3100, a highly optimised DNA immunotherapy for HPV16/18, drove seroconversion
to HPV antigens in 100% of patients while 78% of patients mounted an Interferon Gamma
(IFNg) ELISpot response. Flow analysis revealed IFNg production from both CD4+ and
CD8+ T cells, as well as the induction of patient CD8s with antigen specific CTL activity.
This randomized, placebo-controlled, double-blind Phase II study assessed the safety
and efficacy of VGX3100 in 167 women with biopsy-proven CIN 2/3 with concurrent HPV16
or 18 infection. The study evaluated cervical tissue changes after three 6 mg intramuscular doses of VGX-3100 with Inovio’s CELLECTRA® 2000 electroporation device
at weeks 0, 4, 12. Cervical tissue was examined before starting blinded treatment
and 9 months later.
The study met its primary efficacy endpoint; Significantly higher percentage of VGX3100
treated patients versus placebo showed regression of CIN 2/3 to CIN 1 or no disease
(p = 0.017). In addition, VGX3100 recipients demonstrated significantly stronger post-vaccination
IFNg ELISpot responses and cleared HPV infection concurrent with regression of CIN
lesions.
The efficacy data with VGX3100 support the exciting possibility of treating HPV-associated
cancers.
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