MedicalResearch.com Interview with:
Diane Harper, M.D., M.P.H., M.S.
Professor of Family Medicine and Obstetrics and Gynecology
Senior Associate Director, Michigan Institute for Clinical and Health Research
Physician Director for Community Outreach, Engagement and Health Disparities,
Rogel Cancer Center
MedicalResearch.com: What is the background for this study?
Response: There is no current cure for women with HPV infection that has progressed to CIN 2/3 disease. The only treatment is for the diseased cervix, and does not eliminate the risk of another CIN 2/3 from the HPV infection 15-20 years later.
This vaccine is made from a live virus that has 3 genes inserted: human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins. When the vaccine is injected subcutaneously, the proteins for HPV 16/E6 and E7 and the cytokine LI-2 proteins are made. These proteins trigger the immune response. This is very different form imiquimod which is topical and not specific for HPV.
MedicalResearch.com: What are the main findings?
- The therapeutic vaccine causes complete resolution of both HPV and CIN 3 in about a third of women
- The therapeutic vaccine is twice as effective as placebo
MedicalResearch.com: What should readers take away from your report?
Response: This is a significant advance towards developing a solution for women infected with HPV that has progressed to CIN 2/3 disease that can be done by a advanced provider practitioner or primary care physician and may not require a surgery that can cause reproductive morbidities.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We know that the HPV circular DNA is broken in many places to insert into the human genome and that the place of insertion in the human genome is quite varied. Future research could look at mechanisms for identifying these insertion sites so that they can be targeted to disrupt continued replication of the oncogenes.
MedicalResearch.com: Is there anything else you would like to add?
Response: This could also be an adjunct to other immune therapy for treatment of other HPV associated cancers, including head /neck as well as anal cancers where surgeries are so disfiguring.
Diane M. Harper, Pekka Nieminen, Gilbert Donders, Mark H. Einstein, Francisco Garcia, Warner K. Huh, Mark H. Stoler, Katerina Glavini, Gemma Attley, Jean-Marc Limacher, Berangere Bastien, Elizabeth Calleja. The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up. Gynecologic Oncology, 2019; DOI: 10.1016/j.ygyno.2019.03.250
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