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amlexanox · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 0.5% amlexanox oral rinse | EXPERIMENTAL | Patients treated with an oral rinse containing the active 0.5% amlexanox |
| Vehicle | PLACEBO_COMPARATOR | Patients treated with an oral rinse containing no active |
| Name | Type | Description |
|---|---|---|
| amlexanox | DRUG | 0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks. |
| Vehicle rinse | DRUG | use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed. |
Inclusion Criteria: 1. Patient is 18 years of age or older; 2. Patient has a histologically documented diagnosis of cancer of the head and neck region; 3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over ...
Amlexanox is being studied as a 0.5% oral rinse solution for oral mucositis associated with radiation therapy in patients with head and neck cancer. It is an investigational small molecule developed by Abeona Therapeutics Inc. and is not yet approved for this use.
Amlexanox is a small molecule inhibitor of the phosphodiesterase 4 (PDE4) family, specifically targeting PDE4A, PDE4B, PDE4C, and PDE4D. By inhibiting these enzymes, amlexanox modulates inflammatory signaling pathways, which is the basis for its investigation in inflammatory conditions such as oral mucositis.
Abeona Therapeutics Inc. (ticker: ABEO) is the developer of amlexanox for oral mucositis. The company is evaluating the drug as a 0.5% oral rinse solution in a clinical program focused on radiation-induced oral mucositis in head and neck cancer patients.
Amlexanox is in Phase 2 development for oral mucositis. The program includes one completed Phase 2 trial, and the drug remains investigational and has not been approved by the FDA for this indication.
One Phase 2 trial has evaluated amlexanox for oral mucositis: NCT01083875, titled "Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region." The trial was completed, enrolled 58 participants, and was conducted in the United States.
Yes. The Phase 2 trial NCT01083875 was randomized, double-blind, and placebo-controlled. It enrolled 58 participants aged 18 years and older of all sexes, and it did not use biomarker selection. The study has been completed.