Abstract
Innate immunity is a key component in the pathogenesis of oral mucositis, a universal toxicity of chemoradiation therapy (CRT). Dusquetide, a novel Innate Defense Regulator, has demonstrated both nonclinical and clinical efficacy in ameliorating severe oral mucositis (SOM). Long term follow-up studies from the Phase 2 clinical study evaluating dusquetide as a treatment for SOM in head and neck cancer (HNC) patients receiving CRT have now been completed. Extended analysis indicates that dusquetide therapy was well-tolerated and did not contribute to increased infection, tumor growth or mortality. Potential ancillary benefits of duquetide therapy were also identified.
Highlights
Innate immunity is a key component in the pathogenesis of oral mucositis, a universal toxicity of chemoradiation therapy (CRT)
Interim results from a Phase 2 study evaluating a dose of 1.5 mg/kg of dusquetide as a treatment for severe oral mucositis (SOM) in head and neck cancer (HNC) patients receiving chemoradiation therapy (CRT) demonstrated a 50% decrease in the median duration of severe oral mucositis (SOM) in patients receiving at least 55 Gy irradiation [1]
A co-culture system with human multiple myeloma cells was previously investigated and demonstrated that when dusquetide was pre-incubated with stromal cells, those same stromal cells provided reduced support for multiple myeloma cell growth (Fig. 1)
Summary
Interim results from a Phase 2 study evaluating a dose of 1.5 mg/kg of dusquetide as a treatment for severe oral mucositis (SOM) in head and neck cancer (HNC) patients receiving chemoradiation therapy (CRT) demonstrated a 50% decrease in the median duration of severe oral mucositis (SOM) in patients receiving at least 55 Gy irradiation [1]. Long term follow-up studies from the Phase 2 clinical study evaluating dusquetide as a treatment for SOM in head and neck cancer (HNC) patients receiving CRT have been completed.
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