# Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017

> **NIH FDA R01** · PRIVO TECHNOLOGIES, LLC · 2021 · $99,660

## Abstract

Project Summary
According to the National Cancer Institute, about 50,000 people in the US will be newly diagnosed with oral cancer (OC)
in 2018, causing over 9,700 deaths. OC is a severely neglected orphan disease with a lack of significant treatment advances
in 4 decades and about 64% of patients die within the first 5 years of diagnosis. Historically, OC has been present in heavy
smokers and drinkers. However, more recently OC has also become more prevalent in younger people due to an increase in
cancer-causing human papillomavirus (HPV) spread through oral sex. The current standard of care (SOC) for patients with
early stage disease is surgical intervention. However, this can result in disfiguring side effects that impair oral form and
function such as the ability to speak and swallow. Surgical treatment of OC also has an exceptionally high rate of recurrence,
due in part to tumor margins which are difficult to identify or access.
To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, PRV111 that is applied
directly to the tumor. PRV111 consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded particles (CPs)
and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is
recognized as the gold standard chemotherapeutic for treating oral cancer. However, cisplatin’s efficacy is often hindered
by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration.
CP’s have optimized size, charge, and permeation parameters to ensure that cisplatin is locally retained within the tumor
tissue and not exposed to systemic bodily circulation. Privo has performed 12 sets of in vivo studies in 5 species of animals
to examine the safety and efficacy of PRV111. In all cases, PRV111 has shown robust antitumor effect and no local or
systemic toxicities. The goal of this proposal is the successful completion of Privo’s clinical trial. The results of this study
will be published to share its findings with the scientific and medical community. Privo is confident that its team of expert
scientists, business leaders, and collaborators can execute its defined aims with milestones and deliverables.

## Key facts

- **NIH application ID:** 10204003
- **Project number:** 5R01FD006325-03
- **Recipient organization:** PRIVO TECHNOLOGIES, LLC
- **Principal Investigator:** Manijeh N Goldberg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $99,660
- **Award type:** 5
- **Project period:** 2019-09-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10204003

## Citation

> US National Institutes of Health, RePORTER application 10204003, Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017 (5R01FD006325-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10204003. Licensed CC0.

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