Soligenix reports enrollment stage for its pivotal phase III trial of SGX 942 for oral mucositis in head and neck cancer

Soligenix announced that it has reached a significant milestone in the Phase III clinical study (the "DOM-INNATE" study) for SGX 942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC). Based on the positive and previously published Phase II results (Study IDR-OM-01), the pivotal Phase III clinical trial (Study IDR-OM-02) is designed to be a highly powered, double-blind, randomized, placebo-controlled, multinational trial that seeks to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX 942 or placebo given twice a week during and for two weeks following completion of CRT. 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. Oral mucositis is evaluated using the WHO (World Health Organisation) Grading system. Severe oral mucositis is defined as a WHO Grade of greater than 3. Subjects are followed for an additional 12 months after the completion of treatment.

Comment;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.