Cervical intraepithelial neoplasia (CIN) is the abnormal growth of precancerous cells in the cervix, usually caused by infection with human papillomavirus (HPV). In addition to the key objective of assessing safety and tolerability, a secondary objective of the study is to assess T-cell and B-cell specific HPV-E7 immune responses.
“Advancing our lead therapeutic vaccine program back into human clinical trials represents a major milestone for Nventa,” said Peter Emtage, vice president, R&D at Nventa. “Based on the impressive preclinical data collected to date using HspE7 combined with multiple adjuvants, we expect this trial to produce invaluable safety, tolerability and immunological biomarker data of new HspE7 for use in designing future efficacy trials.”
Following successful completion of this Phase I trial, the company anticipates launching a Phase II clinical trial with new HspE7 in patients with high-grade cervical intraepithelial neoplasia (CIN 2/3). The company is also in discussions with clinical investigators regarding the design and implementation of a second Phase II trial with new HspE7 in patients that are HIV-positive with low-grade CIN.