Soligenix has announced that it has received a positive recommendation from the Data Review Committee to continue enrolling patients into its phase II trial studying SGX942.
SGX942, a novel innate defense regulator, is being evaluated as a treatment for oral mucositis in patients receiving chemoradiotherapy for head and neck cancer.
The committee recommended that researchers enroll 20 additional participants that will be randomly assigned to receive a single dose of SGX942 or placebo.
The additional subject enrollment will allow for a better evaluation of the drug’s potential effect and will better inform final dose selection.
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The double-blind, dose-ranging, placebo-controlled, phase II trial was initially planned to enroll about 75 participants and to randomly assign them to receive one of three SGX942 doses or placebo.
The primary efficacy endpoint is the comparison of the incidence and/or duration of both ulcerative and severe oral mucositis across the four groups throughout the 7 weeks of treatment and for 4 weeks after treatment.
SGX942 has both anti-inflammatory and anti-infective activity. It works by modulating host responses, rather than having direct antibiotic activity, which ultimately increases survival after infections and accelerates resolution of tissue damage caused by bacterial pathogens, trauma, chemotherapy, and radiotherapy.