Cervical Dysplasia/Cancer and Human Papilloma Virus (HPV)
Cervical dysplasia is classified by two systems : by histopathology (biopsy) or by cytology (PAP smear). Based on histopathology, three CIN (cervical intraepithelial neoplasia) grades are defined: CIN1 (mild dysplasia), CIN2 (moderate dysplasia) and CIN3 (severe dysplasia) lesions. Based on cytology, two grades are defined: LSIL (low grade squamous intra-epithelial lesions) or HSIL (high-grade squamous intraepithelial lesions). Usually LSIL and CIN-1 overlap, and HSIL and CIN-2 and CIN-3 overlap. About 10% of LSIL/CIN-1 eventually progress to cervical cancer, while about 50% of HSIL/CIN-2/CIN-3 progress to cervical cancer. Effective treatment of cervical dysplasia therefore would prevent development of cervical cancer.
HPV Incidence Remains High in Spite of HPV Vaccine – Need for HPV Treatment Remains
HPV vaccines were introduced over a decade ago (Gardasil® was approved in 2006). While this has clearly resulted in a decrease in HPV incidence in certain age groups (ages 15-24), the impact on HSIL incidence overall remains modest .
Cervical Low- and High-Grade Squamous Intraepithelial Lesions — Prevalence per 1000 Person-Years Among Female Enrollees in Private Health Plans Aged 15–39 Years, by Age Group and Year, 2007–2014. Source: Centers for Disease Control and Prevention
Treatments for HSIL 
- All treatments Invasive (LEEP is the most common procedure used)
- All have risk of significant complications, including:
- Cervical incompetence (which can result in miscarriage and preterm labor)
- Cervical stenosis
- Difficulty getting pregnant
- Invasive treatment procedures (LEEP, etc.) are not always curative (HPV persists)
There is a high unmet need for a new, safe non-invasive treatment especially for HSIL, to resolve cervical dysplasia and become HPV free. Any treatment that would avoid the side effects associated with procedures like LEEP would be significant patient benefit and healthcare cost savings.
- WHO (2014) Comprehensive Cervical Cancer Control: A Guide to Essential Practice. 2nd Edition. Available at: https://www.ncbi.nlm.nih.gov/books/NBK269605/
- WHO. (2018). Human papillomavirus (HPV) and cervical cancer. [online] Available at: http://www.who.int/mediacentre/factsheets/fs380/en/
- NCI: HPV and Cancer [online]. Available at: https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-fact-sheet
- Centers for Disease Control & Prevention. Sexually transmitted diseases (STDs). 2016 sexually transmitted diseases surveillance. Other sexually transmitted diseases. https://www.cdc.gov/std/stats16/other.htm#hpv
- Kaiser Family Foundation. The HPV vaccine: access and use in the US. Fact Sheet. October 2017. http://files.kff.org/attachment/fact-sheet-the-hpv-vaccine-access-and-use-in-the-u-s