# Supplement to Promote Diversity, Inclusion, and Career Development of a Female Scientist

> **NIH NIH R44** · NAVEGA THERAPEUTICS, INC. · 2022 · $134,086

## Abstract

Project Summary/Abstract
The goal of this project is to develop a gene therapy product that relieves chemotherapy-induced
peripheral neuropathy (CIPN) in a non-permanent, non-addictive and long-lasting manner to
improve the quality of life of cancer patients. Current management of CIPN and cancer pain is
very poor, with 1 in 3 patients not receiving pain medication considered appropriate for the
intensity of pain experienced. With the limited efficacious treatment options available, opioids are
often prescribed, however these can lead to addiction. We are in urgent need of novel pain
therapies that would alleviate the side effects of opioids. Voltage- gated sodium channels (NaV
family) have been used in nociceptive transmission and contribution to the hyperexcitability in
primary afferent nociceptive neurons. Additionally, many chemotherapy agents induce ion
channel expression including NaV1.7 and NaV1.8, leading to CIPN. Hence, these sodium channels
have been attractive targets for developing chronic pain therapies. However, the high homology
of human NaV proteins has frustrated most efforts to develop selective protein inhibitors. Instead
of targeting the protein, Navega proposes to develop a non-permanent epigenome regulation
tool to target pain. This novel approach is non-addictive, highly specific, and long-lasting. During
Phase I, we determined that the simultaneous inhibition of NaV1.7 and NaV1.8, was more
efficacious at reversing CIPN than repressing each channel alone. We also demonstrated the
safety of our approach at doses tested in mice. During Phase II we will: 1) perform dose-range
studies in mice to determine the therapeutic window; 2) optimize our reagents to target the human
genome; and 3) perform GLP definitive safety studies in NHPs. We will prepare an IND application
to the FDA, and will submit it at the end of the Phase II project. Our final goal is to develop novel
therapeutics that can mitigate CIPN through the use of a specific gene therapy approach that can
simultaneously target two voltage gated sodium channels (something not possible with small
molecules) and provide an alternative treatment to opioids for patients with chronic pain.

## Key facts

- **NIH application ID:** 10534074
- **Project number:** 3R44CA239940-02S1
- **Recipient organization:** NAVEGA THERAPEUTICS, INC.
- **Principal Investigator:** Fernando Aleman Guillen
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $134,086
- **Award type:** 3
- **Project period:** 2021-12-31 → 2023-08-23

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10534074

## Citation

> US National Institutes of Health, RePORTER application 10534074, Supplement to Promote Diversity, Inclusion, and Career Development of a Female Scientist (3R44CA239940-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10534074. Licensed CC0.

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