# Proprietary drug to treat radiodermatitis

> **NIH NIH R44** · ALLANDER BIOTECHNOLOGIES, INC. · 2020 · $1,157,986

## Abstract

Summary
Radiodermatitis is skin tissue damage that occurs in 95% of cancer patients receiving radiotherapy (RT).
Although modern RT, e.g., intensity-modulated RT (IMRT) or stereotactic body RT (SBRT), spares more skin
areas from RT damage than regular RT, radiodermatitis is still the major toxicity in skin cancer patients treated
with SBRT as well as in other cancer patients treated with regular RT where IMRT/SBRT are either unavailable
or not suitable, e.g., breast cancer patients. Severe radiodermatitis causes skin erosion, opiate-resistant pain
and long-term fibrosis. Current treatments largely aim to ameliorate “skin burn” rather than promoting healing.
Allander Biotechnologies, LLC. has developed a proprietary drug to treat radiodermatitis via anti-inflammation,
anti-fibrosis, promoting DNA damage repair, and promoting re-epithelialization. To date, we have established a
drug production platform, feasibility for efficacy, safety, and pharmacodynamics (PD) markers to develop our
drug into a topically applied drug product. In this Phase II application, we will develop Good Manufacturing
Practice (GMP)-scalable production and establish reference standards for our drug substance and drug product.
We will perform IND (investigational new drug)-enabling PD and pharmacokinetics (PK) studies. We will evaluate
potential toxicity of our drug during topical treatment of radiodermatitis in mice and dogs. We will also perform
Good Laboratory Practice (GLP) compliant systemic toxicology studies in rodents via intentional systemic
delivery of our drug. By the end of Phase II funding, we will have IND data for CMC (Chemistry, Manufacturing
and Controls), preclinical PD/PK, potential cutaneous and systemic toxicities in mice and dogs resulted from
topical treatment doses, and GLP systemic toxicology in rodents. These data will allow us to design GLP
toxicology studies in a larger species, which will be completed with additional funding for IND filing before
initiating a Phase I clinical trial.

## Key facts

- **NIH application ID:** 10147400
- **Project number:** 1R44AR078669-01
- **Recipient organization:** ALLANDER BIOTECHNOLOGIES, INC.
- **Principal Investigator:** Xiao-Jing Wang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,157,986
- **Award type:** 1
- **Project period:** 2020-09-24 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10147400

## Citation

> US National Institutes of Health, RePORTER application 10147400, Proprietary drug to treat radiodermatitis (1R44AR078669-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10147400. Licensed CC0.

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