Thursday, July 10, 2014 10:04:59 PM
Some background from the Phase I trial.
Taken from the INO company website:
In 2010, Inovio completed a phase I dose escalation study of VGX-3100, its investigational therapeutic cervical dysplasia synthetic DNA vaccine designed to treat pre-cancerous cervical dysplasias and cervical cancers, delivered with its CELLECTRA® electroporation device. Of all phase I trial subjects evaluated to date, 100% of study participants reported antibody positivity to at least two vaccine antigens and 78% of the subjects showed T-cell responses to at least one vaccine antigen. These results indicate that VGX-3100 has the potential to drive robust immune responses to antigens from high risk types of HPV infection as well as generate an immune response powerful enough to initiate a killing effect on cells changed into precancerous dysplasias by HPV. Building on positive outcomes of an 18-subject phase I dose escalation study that achieved best-in-class immune responses, a phase II clinical trial evaluating VGX-3100 for the treatment of cervical dysplasias is ongoing. This randomized, placebo-controlled, double-blind study has enrolled adult females with CIN 2/3 or CIN 3 and biopsy-proven HPV 16 or 18. Inovio expects to report unblinded, top-line data from this trial in mid-2014.
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