# Support for Registration Enabling Phase 3 Clinical Trial for Nanotechnology-Based Treatment of Carcinoma in Situ of the Oral Cavity (Stage 0 Oral Cancer)

> **NIH NIH R44** · PRIVO TECHNOLOGIES, LLC · 2024 · $2,084,026

## Abstract

RFA-CA-22-025 application entitled “Support for Registration Enabling Phase 3 Clinical Trial for
Nanotechnology-Based Treatment of Carcinoma in Situ of the Oral Cavity (Stage 0 Oral Cancer)”
Project Summary:
According to the American Cancer Society, about 54,000 people in the US will be newly diagnosed with oral
cancer (OC) in 2022, causing 11,230 deaths. Historically, OC has been present in heavy smokers and drinkers,
however OC has also become more prevalent in younger populations due to human papillomavirus (HPV).
Survivors must manage devastating lifelong side effects of treatments which can lead to permanent psychological
damage and physical disfigurement. The diminished quality of life is due to the permanent physical disabilities
resulting from surgery, the first-line treatment regardless of stage. These include permanent speech impairment,
an inability to swallow, and/or the loss of the jawbone due to the surgical removal of the tongue and other oral
tissue. The long-term costs associated with the treatment and these disabilities can range from $100,000-
$250,000, resulting in oral cancer persisting as one of the most expensive of all cancers to treat.
To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, PRV111, capable
of transmucosal drug delivery that is applied directly to the tumor. PRV111 consists of a mucoadhesive polymeric
patch with embedded cisplatin-loaded nanoparticles and a non-permeable backing that facilitates unidirectional
drug release, maintaining locoregional control of the drug application to the tumor site. Cisplatin is recognized as
the gold standard chemotherapeutic agent for treating oral cancer, however its efficacy is often hindered by
significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. PRV111
capitalizes on cisplatin’s cytotoxicity, without systemic side effects, through the localized delivery. The PRV111
nanoparticles are optimized to ensure that cisplatin is locally retained within the tumor tissue and not exposed to
systemic bodily circulation. PRV111 has been investigated in a phase 1/2 trial in patients with early-stage OC.
The trial met all safety and efficacy primary endpoints, with PRV111 having an 87% overall response rate with
an average tumor reduction of 70% in 5.5 days of treatment and labs demonstrating no cisplatin in patient blood.
The goal of this proposal is to support the successful completion of Privo’s Phase 3 clinical trial in Stage 0
OC/Carcinoma in situ (CIS). The goal of this trial is to eliminate the need for standard of care surgical resection
by offering PRV111 as a chemoablative alternative. Surgery for CIS carries high degrees of functional and
cosmetic morbidity, as these tumors are often shallow and widespread necessitating large amount of tissue to be
removed. Data from the previous clinical trial demonstrated that PRV111 was able to chemoablate the epithelium
in all treated patients, so the Comp...

## Key facts

- **NIH application ID:** 10911576
- **Project number:** 2R44CA281020-07A1
- **Recipient organization:** PRIVO TECHNOLOGIES, LLC
- **Principal Investigator:** Manijeh N Goldberg
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,084,026
- **Award type:** 2
- **Project period:** 2024-06-14 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10911576

## Citation

> US National Institutes of Health, RePORTER application 10911576, Support for Registration Enabling Phase 3 Clinical Trial for Nanotechnology-Based Treatment of Carcinoma in Situ of the Oral Cavity (Stage 0 Oral Cancer) (2R44CA281020-07A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10911576. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*