Prophylactic and therapeutic oral gel to prevent and treat radiation-induced mouth ulcers in cancer patients
Official title: cGMP manufacturing the clinical batch of oral gel drug for treating oral mucositis in cancer patients
Funded at Allander Biotechnologies, INC. · NIH-11321353 · Data updated 2026-11-12
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.
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 16, 2026 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $1,210,798 |
| NIH project number | 1R44DE034643-01A1 |
| Project ID | NIH-11321353 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients undergoing radiation or chemoradiation for cancer who are at risk for oral mucositis and would be eligible for future clinical testing.
✕Less likely to help
Patients not at risk for oral mucositis or not enrolled in future clinical trials may not directly benefit.
What this research studies
This grant supports producing a clinical-ready oral gel and the processes needed to start human testing for preventing and treating oral mucositis in cancer patients receiving radiation therapy. The work includes scaling up manufacturing under good engineering practices, establishing release criteria, and validating tests to measure how the gel behaves in the body. Researchers plan to complete the steps required to file an investigational new drug (IND) application and begin first-in-human studies. If successful, patients undergoing cancer treatment could have a new option to reduce or shorten painful mouth ulcers and improve treatment tolerance.
Why it matters
Potential benefit: If successful, patients could experience fewer or less severe oral ulcers during cancer therapy, aiding treatment continuity and comfort.
How similar studies have gone: Prior therapies target prevention (e.g., keratinocyte growth factor) but do not address existing mucositis; this work presents a novel topical gel with both prophylactic and therapeutic potential.
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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First-in-human topical gel for preventing and treating radiation-induced oral ulcers in cancer patients
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.
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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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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.