Soligenix reaches enrollment milestone in Phase 3 trial of SGX942
Soligenix has reached an enrollment milestone in the Phase 3 clinical study for SGX942 - dusquetide - in the treatment of oral mucositis in patients with head and neck cancer, or HNC. Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee. Approximately 90 subjects have been enrolled into the study. Soligenix has been working with oncology centers internationally, a number of which participated in the Phase 2 study, to advance this Phase 3 clinical trial. Based on the positive and previously published Phase 2 results, the pivotal Phase 3 clinical trial seeks to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Patient recruitment is anticipated to be completed 2019 with top-line results available in the first half of 2020, pending the outcome of the interim analysis.