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Status: Phase II start planned for 2020

 

• Oral mucositis is a major, acute complication of radiotherapy and chemotherapy

 

• Radiation-induced oral mucositis (RIOM) is a well-described, debilitating toxicity affecting up to 80% of Head and Neck Cancer patients treated with radiotherapy. An estimated 56% of patients with RIOM develop a severe form of the complication.

 

• Approximately 95,000 Head and Neck Cancer patients in the US are at risk of developing RIOM every year (VasoDynamics estimate based on published sources).

 

• RIOM starts as an acute inflammation of the mouth, tongue and pharynx mucosa, followed by multiple erosions as a result of epithelial and basement membrane damage. 

 

• Symptoms include oral pain and swallowing difficulty leading to weight loss and frequent opioid use (>50% of patients): 70% of patients with Grade 3-4 RIOM require a feeding tube.

 

• RIOM represents a major clinical challenge, including radiation-dose limitations and changes in the dose fractionation protocol (with a potential negative impact on treatment outcomes) coupled with a dramatic, negative effect on the patient’s quality of life

 

• RIOM is associated with significant additional healthcare cost, estimated at $17,000 per patient with Head & Neck Cancer.

 

• Current therapy is palliative (dietary change, pain relief medication and oral care) and no topical preventative therapy currently exists.