# Preventing Cervical Cancer in the First Mile of the Cancer Care Continuum

> **NIH NIH R00** · UNIV OF MARYLAND, COLLEGE PARK · 2020 · $249,000

## Abstract

Cervical cancer is the second leading cause of death for women worldwide with 85% of deaths occurring in
low- and middle-income countries (LMICs), despite the fact that well-established interventions exist for pre-
invasive disease. One of the barriers to cervical cancer prevention is reliable access to treatment. Cryotherapy,
which is the current therapy recommended by the World Health Organization (WHO) for treating cervical pre-
cancer in LMICs, requires a continuous supply of pressurized liquid nitrogen, which is expensive and difficult to
transport, and does not adequately treat advanced lesions. More recently, the thermocoagulator has gained
acceptance for ablation of cervical pre-cancer lesions because of its ability to treat both low-grade and high-
grade pre-cancers. However, thermocoagulation (while effective) has a price point of $1500 to $3,000, which is
inaccessible at the community level. These well-documented shortcomings demonstrate a clear unmet clinical
need to develop new treatment strategies to prevent cervical cancer in LMICs. To meet this unmet need, our
group has recently developed a novel tumor ablation technique based on ethanol ablation. Ethanol ablation
was previously developed as a low-cost treatment for encapsulated, inoperable liver tumors, and involves
manual injection of pure ethanol into malignant tissue. Preclinical studies showed that while manual injection of
pure ethanol is ineffective in treating epithelial lesions, a novel formulation that combines ethanol with an agent
ethyl cellulose substantially improved efficacy and induced complete regression of 7 out of 7 tumors. Ethyl
cellulose not only makes ethanol more viscous (which prevents backflow) but also forms a gel in an aqueous
medium, which sequesters ethanol in the region of interest. Gel ethanol does not require hard-to-supply
consumables and has the potential to be ultra-low-cost and highly portable. The goal of this proposal is to
optimize the injection procedure and delivery mechanism to treat pre-invasive lesions of the cervix as an
alternative to thermocoagulation. To achieve this, the aims are to: 1) establish a method to optimize gel ethanol
delivery, 2) assess the safety and efficacy of optimized delivery in a large animal model, and 3) conduct an
initial assessment of an optimized delivery procedure in the human cervix. The K99 phase includes the
optimization of the gel ethanol injection procedure in Aim 1 and the preclinical studies proposed in Aim 2,
which will lay the groundwork for a pre-investigational new drug (IND) meeting and transitioning to clinical
studies. The R00 phase includes the optimization of a gel ethanol delivery mechanism and translation to
human studies. An independent clinical study is proposed for the R00 portion of the award. These aims will
lead to an optimized gel ethanol delivery procedure whose safety and efficacy are validated in a large animal
model with an initial assessment in human cervices, which will lay the...

## Key facts

- **NIH application ID:** 10201847
- **Project number:** 4R00CA234455-03
- **Recipient organization:** UNIV OF MARYLAND, COLLEGE PARK
- **Principal Investigator:** Jenna Lynne Hook Mueller
- **Activity code:** R00 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $249,000
- **Award type:** 4N
- **Project period:** 2020-09-08 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10201847

## Citation

> US National Institutes of Health, RePORTER application 10201847, Preventing Cervical Cancer in the First Mile of the Cancer Care Continuum (4R00CA234455-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10201847. Licensed CC0.

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