First-in-human topical gel for preventing and treating radiation-induced oral ulcers in cancer patients
Official title: First-in-human clinical trial of proprietary oral gel to treat radiation-induced oral mucositis in cancer patients
Funded at Allander Biotechnologies, INC. · NIH-11411493 · Data updated 2026-11-12
A new oral gel applied to the mouth is being tested to prevent and treat painful mouth ulcers caused by cancer radiation therapy, with early safety and dosing data gathered in people.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Allander Biotechnologies, INC. NIH-funded |
| Lab location | 1 site (Aurora, United States) |
| Project start | September 15, 2025 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,066,148 |
| NIH project number | 5R44CA310522-02 |
| Project ID | NIH-11411493 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with head and neck cancer undergoing radiation therapy who are at risk for developing oral mucositis and are eligible for a first-in-human topical therapeutic trial.
✕Less likely to help
Patients not at risk for mucositis or who have contraindications to the topical gel may not derive direct benefit.
What this research studies
This project tests a proprietary oral gel designed to protect and heal the lining of the mouth in patients receiving radiation therapy for head and neck cancer. The gel is applied topically to the oral mucosa and has shown protective and therapeutic effects in animal studies, with manufacturing, dosing, and safety testing completed to support a first-in-human trial. The study will monitor safety, pharmacodynamics, and pharmacokinetics as the gel is given to participants, aiming to establish an appropriate dose and observe potential reductions in mucositis severity. If successful, this approach could reduce treatment interruptions and improve quality of life for patients undergoing RT or CRT for cancer.
Why it matters
Potential benefit: If successful, patients may experience fewer or less severe mouth ulcers during cancer radiotherapy, potentially allowing fuller, more effective treatment with less discomfort.
How similar studies have gone: Animal studies showed protective and therapeutic effects of the gel; human data are being generated in this first-in-human trial.
Where this research is happening
-
Allander Biotechnologies, INC.
Aurora, United States Active
Researchers
- Principal investigator: Young, Christian — Allander Biotechnologies, INC.
- Study coordinator: Young, Christian
Related research
Other NIH-funded projects on the same topics.
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Understanding how biological sex affects radiation-induced oral mucositis
This grant explores why women and men experience different severity of mouth sores during head and neck cancer radiotherapy and how to tailor treatments to reduce pain and healing time.
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New medicine to prevent or lessen painful mouth sores from radiation
This project develops a potential drug to prevent or shorten painful mouth sores that happen after radiation therapy for head and neck cancer.
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Protecting the mouth from radiation in head and neck cancer
A Duke University-based study looks at how the p53 protein may guard the mouth from radiation-related damage in people with head and neck cancer.
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Prophylactic and therapeutic oral gel to prevent and treat radiation-induced mouth ulcers in cancer patients
A new topical gel shown in animals may prevent or treat painful mouth ulcers caused by cancer radiation therapy, with plans to move toward human testing.
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A new medicine to prevent and treat radiation-related mouth sores
A new oral drug is being developed to prevent or shorten painful mouth sores in people getting radiation to the head and neck.
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Understanding and treating pain and mouth sores from radiation for head and neck cancer
This work explores new ways to relieve the burning pain and mouth sores that often happen after radiation therapy for head and neck cancer.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.