Inovio Biomedical Corporation (INO) said Monday that data from an early-stage study of its therapeutic cervical cancer vaccine, VGX-3100, demonstrated that the vaccine was generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered.
VGX-3100 is a proprietary, therapeutic DNA vaccine for the treatment of cervical intraepithelial neoplasias caused by human papillomavirus, or HPV, types 16 and 18. The vaccine includes plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18, and is delivered through vivo electroporation.
The phase I clinical trial was meant to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia 2/3, a precursor lesion prior to the development of cancer. The dose escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg, 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose.
Inovio said it has completed immunizations of the lowest dose cohort, and all six subjects tolerated the vaccine administration and electroporation procedure well over each of the three vaccinations. Adverse events and injection site reactions were noted to be mild to moderate and required no treatment.
Inovio said the VGX-3100 clinical trial is now enrolling the second cohort of patients. Full enrollment of all three cohorts are expected to be in the first half of 2010 and full analysis of immunogenicity and safety data by third quarter of 2010.
INO closed Friday's regular trading at $1.69 per share on the NYSE.
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