Soligenix, a development stage biopharmaceutical company, has reported the preliminary results from its Phase 1/2 clinical study of SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), used for the prevention of acute radiation enteritis.
SGX201 is a time-release, oral formulation of BDP, and has been granted fast-track designation from the US Food and Drug Administration for the prevention of radiation enteritis.
The open label, randomised, dose-finding Phase 1/2 protocol BDP-ENT-01 enrolled 16 patients with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery.
The primary aim of the study was to demonstrate the safety and tolerability of escalating doses of SGX201, and to evaluate the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis.
The study showed that the administration of SGX201 was found to be safe and well tolerated across all four dose groups.
Soligenix chief medical officer Kevin Horgan said: "This clinical trial in radiation enteritis with SGX201 provided encouraging exploratory data, which we will be submitting for publication."
He added: "Though the numbers are small, the low incidence of diarrhea relative to other similar studies was notable. These findings appear to be consistent with the potential for SGX201 having efficacy for this disorder for which there is currently no available therapy."
William Small, Jr., a principle investigator for the Phase 1/2 clinical study, said: "Based on oral BDP's proven pharmacology in treating severe gastrointestinal inflammation, SGX201 represents a potential prophylactic option that would enable physicians/patients to maintain planned treatment regimens to battle the underlying malignancy."
Small added: "I find these exploratory data encouraging and I look forward to continuing to work with Soligenix on the continued development of SGX201 in this area of great unmet medical need."
National Cancer Institute (NCI) has awarded a two-year Small Business Innovation Research (SBIR) grant of approximately $510,000 as a support to advance the trial.