# Development of ablative therapy for the destruction of cervical neoplasia

> **NIH NIH R43** · GYNION, LLC · 2024 · $367,472

## Abstract

PROJECT SUMMARY
Cervical intraepithelial neoplasia (CIN) is caused by the sexually transmitted Human Papilloma Virus (HPV),
which infects 14 million women in the US every year and is the most common viral infection of the reproductive
tract. Over 3 million US women are infected with oncogenic types of HPV that most commonly lead to CIN, and
up to 1 million women are diagnosed with CIN each year in the US. CIN is a precancerous lesion that, if left
untreated, can develop into cervical cancer. There are about 604,000 new cervical cancer cases and over
342,000 attributable deaths in 2020. This constitutes 9% of the global burden of cancer among women. Despite
improvements in screening and vaccination, the rates of cervical cancer have increased globally by 45% in the
last 30 years. Current treatment strategies against CIN are defined by the World Health Organization and include
both ablative (cryotherapy) and excisional (loop electrosurgical excision and cold knife conization) procedures.
While both have proven beneficial in treating CIN, they are associated with different limitations: cryotherapy lacks
effectiveness and is limited because of the logistic constraints associated with gas cost, procurement, and
storage; excisional procedures carry the risk of adverse obstetric outcomes. The need for capital equipment and
the shortage of providers with the skills to use it, result in up to 80% of women diagnosed with CIN never receiving
the recommended treatment. This issue of undertreatment also specifically affects black women in the US. There
is thus, an unmet need for a simple, effective, and affordable technology capable of deploying treatment
at point-of-care as soon as the woman is diagnosed with CIN. Gynion will address this unmet need with the
Clarablex™ gel which is formulated with Trichloroacetic Acid (TCA) as the active ingredient and indicated for the
destruction of oncogenic HPV and CIN. Clarablex does not require capital equipment. It will be provided in
prefilled syringe cartridges and will be available for immediate use at any cervical cancer screening facility. TCA
has been successfully used as a low-viscosity “water-like” solution in clinical trials as a chemical ablative agent
against CIN lesions. Clarablex has an improved proprietary formulation that has a gel-like viscosity, enabling
precise application to the target tissue and predictable ablation depth. This improves efficacy, enhances safety,
prevents accidental spillage and damage to healthy tissue, and simplifies the procedure. The formulation is
delivered with a single-use applicator that safely applies Clarablex topically on the surface of the cervix and
chemically destroys neoplastic lesions during a quick 10-minute procedure. The treatment has a cost of goods
of less than $10 per treatment. Preliminary research demonstrates the ability of the Clarablex to ablate cervical
tissues up to 7-8 mm penetration, which is expected to be sufficient to treat even high-grade CIN lesi...

## Key facts

- **NIH application ID:** 10919966
- **Project number:** 1R43CA285184-01A1
- **Recipient organization:** GYNION, LLC
- **Principal Investigator:** Oleg United States Shikhman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $367,472
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10919966

## Citation

> US National Institutes of Health, RePORTER application 10919966, Development of ablative therapy for the destruction of cervical neoplasia (1R43CA285184-01A1). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10919966. Licensed CC0.

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