Tipapkinogen Sovacivec is a therapeutic vaccine candidate which has inserted genes that code for three proteins: human cytokine IL-2 and modified forms of HPV 16 E6 and E7 proteins that have been rendered non-oncogenic. It utilizes the modified vaccinia virus Ankara (MVA) which is a highly attenuated replication-deficient strain of vaccinia virus as the gene-delivery system.
MVA by itself contributes to the immune reaction by the induction of an Interferon-alpha response.
Tipapkinogen Sovacivec is indicated to treat women with high-grade CIN associated with HR-HPV infection.
Tipapkinogen Sovacivec is administered as a sub-cutaneous injection.
Clinical Trial NCT01022346: A Study of RO5217790 in Participants With High-Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High-Risk Human Papillomavirus (HR-HPV) Infection
- This Phase 2 randomized, double-blind, placebo-controlled, parallel-arm study will assess the safety and the efficacy of RO5217790 on the histologic resolution in participants with high-grade CIN associated with HR-HPV infection.
- Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15.
- Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.