Soligenix announced positive results from the Phase 2 clinical trial of SGX942, for the treatment of oral mucositis in patients treated with chemoradiation therapy (CRT) for head and neck cancer.

The Phase 2 study evaluated three doses of SGX942 (1.5mg/kg, 3mg/kg, 6mg/kg) compared to placebo in 111 patients undergoing CRT for head and neck cancer. Results showed that SGX942 successfully achieved all objectives and identified 1.5mg/kg as the best dose.

Patients treated with SGX942 1.5mg/kg had a decrease in the median duration of severe oral mucositis by 50%—from 18 days to 9 days (P=0.099). In addition, the greatest reduction of severe oral mucositis (67%) was seen in patients receiving the most aggressive CRT in this treatment group—from 30 days to 10 days (P=0.040). Detailed results of the trial will be submitted for future presentations and publications.

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Currently, there are no FDA-approved preventative or therapeutic agent for oral mucositis in head and neck cancer. SGX942 had previously received Fast Track designation from the FDA for the same indication.

SGX942 is a first-in-class Innate Defense Regulator (IDR). This is a new class of short, synthetic peptides with a novel mechanism of action that modulates the body’s innate immune response to injury and infection through anti-inflammatory and anti-infective properties.

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