ry.htm">electroporation device in a randomized, placebo-controlled, double-blind Phase II clinical study. We believe that these newly reported Phase I data showing long term persistence of antigen-specific T cells further support our confidence and optimism for ultimately meeting the primary endpoint of this Phase II efficacy study: the clearance of CIN 2/3 lesions, measured at month 9, after three vaccinations at months 0, 1, and 3," concluded Dr. Kim.
This recently initiated Phase II study will enroll 148 patients with CIN 2/3 or CIN 3 at approximately 25 study centers in the US, Korea, South Africa, Australia, and Canada. The study will also assess humoral and cell mediated immune responses to VGX-3100 in blood samples taken prior to the first vaccine dose and periodically thereafter. Cervical samples will be analyzed for evidence of immune responses in the cervix at baseline and subsequent intervals. Subjects will also be monitored for tolerability and safety.
The clinical trial protocol, HPV-003, is available at: http://clinicaltrials.gov/ct2/show/NCT01304524?term=NCT01304524&rank=1.
About Cervical Dysplasias/Cancers
Human papillomavirus (HPV) is the causative agent responsible for most cases of cervical cancer. At any given time, approximately 10% of women worldwide are infected with HPV. While roughly 70% of HPV infections are cleared by the body on its own, persistent HPV can lead to dysplasia, or premalignant changes in cells, of the cervix. Researchers have estimated the global prevalence of clinically pre-cancerous HPV infections at between 28 and 40 million. Persistent dysplasias may then progress to cancer. Every year, 510,000 cases of cervical cancer are diagnosed worldwide, and about 288,000 of the afflicted women, primarily in developing countries, die.
Preventive vaccines such as GARDASIL® and
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