Topical Nitric Oxide Therapy to Treat Cervical Neoplasias and Prevent HPV-Associated Cancers
Abstract
The proposed research aligns with the focus area of Fiscal Year 2018 Peer Reviewed Cancer Research Program Impact Award that aims to improve quality of life by decreasing the impact of cancer on active Service members, their families and the American public. Cancer caused by human papillomavirus (HPV) has heightened militarily relevant risk given that HPV, as an infectious agent, is the most common sexually transmitted infection within the U.S. military. Additionally, more than 90% of the active U.S. military members and their families are adolescents and young adults (AYAs) and approximately 70,000 of all AYAs are diagnosed with cancer each year in the U.S. Cervical cancer, caused by persistent high-risk HPV infections, is one of the most common cancers diagnosed in AYAs and is the second most common cancer among military women. In female Service members, HPV prevalence is reported to be up to 51%, whereas the prevalence in the general population of women is less than 30%. HPV vaccination is encouraged and offered to Service members, but it is not mandatory and reported completion of the three-vaccine series in female Service members is low, only 16%. Pap smears are used to detect precancerous lesions of the cervix, or neoplasias, but there are no predictive criteria that will determine which neoplasias will progress to cervical cancer. Alarmingly, there are no Food and Drug Administration-approved therapeutics indicated to treat cervical neoplasias. As a result, there are an estimated 250,000 to 1 million women diagnosed with precancerous cervical neoplasias annually in the U.S. Standard of care includes watch-and-wait for cells to heal on their own or surgical procedures to excise the abnormal tissue. However, invasive procedures are often associated with pain, anxiety and increased risk of pre-term birth in future pregnancies due to cervical incompetence and, since they do not address the underlying HPV infection, may result in recurrence. Once diagnosed with abnormal cervical screening results, female Service members experience difficulties in follow-up care due to military operational complexities such as deployments, relocations, and job duties. The goal of this research proposal is to develop a nitric oxide-releasing vaginal suppository that can be self-administered by female patients as a treatment for precancerous cervical lesions that eradicates latent HPV infection and inhibits disease progression to cancer. Nitric oxide is a potent antimicrobial generated naturally as part of the bodys defense mechanism against invading viruses like HPV. Novans core science enables the delivery of nitric oxide in localized, targeted formulations, which have been demonstrated to kill cancer-causing HPV infected cells. Additionally, the company has demonstrated the ability to achieve complete clearance of all genital warts caused by HPV in a 108 patient clinical trial. A field deployable, self-administered therapy, specifically formulated for women as vaginal suppository that could treat the precancerous once diagnosed, regardless of stage, could allow for a flexible treatment option that: • is safe, based on the bodys natural immune response to fight viruses; • targets the underlying HPV infection to prevent recurrence; • does not require in-office procedures and time away from active duty; • could decrease the transmission of the high-risk HPV infection between partners to protect the Service men and women of the U.S. and the general population; and as a result • could reduce the incidence of cervical cancer associated with high-risk HPV.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910850
Entities
People
- Carri Geer
Organizations
- United States Army