Inovio Pharmaceuticals Inc (INO)

[cwwan1]

VGX-3100 Phase II Study
•Placebo-controlled, randomized, doubled blind
•148+ subjects: females 18-55 •Histologically confirmed HPV16 or 18-associated CIN 2/3 or 3
•3:1 VGX-3100/electroporation vs. placebo/electroporation
•Two plasmids: Type 16 and Type 18, each encoded for E6/E7 antigens; 3 mg/ml per plasmid; treatment at months 0, 1, 3
•Primary endpoint month 9
•Regression of CIN 2/3 to CIN 1 or less •80% powered for 27% increase relative to natural regression (25% assumption) in placebo group, i.e 52%
•Secondary endpoints
•Clearance of HPV 16 or 18 •Immunogenicity
•Safety