The primary objective of the study is to evaluate the safety and tolerability of SGX201 and assess the preliminary efficacy of SGX201 for prevention of symptoms of acute radiation enteritis.
The open label randomized study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups.
The study has found evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis.
The assessment was according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events.
Soligenix chief medical officer Kevin Horgan said the clinical trial in radiation enteritis with SGX201 provided encouraging exploratory data, which they will be submitting for publication.