Pennsylvania-based vaccine developer Inovio Pharmaceuticals has released positive Phase I results for its cervical dysplasia and cancer vaccine, VGX-3100. According to Dr. J. Joseph Kim, Inovio's president and CEO, the company will move forward with Phase II testing.
The study included 18 patients with moderate or severe cervical intraepithelial neoplasia, and 72 percent of them had significant T-cell responses to the vaccine within four months of treatment. The T-cell immune response persisted for nine months in 91 percent of those patients. Subjects were inoculated three times, with additional doses at one and three months after the initial vaccination.
The new Phase II study will enroll 148 patients to be treated at one of 25 participating centers in the U.S., Korea, South Africa, Canada and Australia. "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," Dr. Kim said in a release.
- read the Inovio release