Soligenix Initiates Phase 1/2 Clinical Trial Of SGX201

Soligenix, formerly known as Dor BioPharma, has initiated a phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis. The study will be supported in large part by a two-year Small Business Innovation Research (SBIR) grant award, which will provide Soligenix with approximately $510,000 in funding.

The phase 1/2 protocol BDP-ENT-01 is a multicenter, open-label, sequential, dose-escalation study in approximately 36 patients. Patients with rectal cancer who are scheduled to undergo concurrent radiation and chemotherapy prior to surgery will be enrolled in one of four escalating dose groups. The objectives of the study are to evaluate the safety and maximal tolerated dose of escalating doses of SGX201, as well as the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. The study is expected to be completed in the first half of 2011.

Christopher Schaber, president and CEO of Soligenix, said: “The initiation of this new clinical trial in radiation enteritis with SGX201 represents the next step in the expansion of our oral BDP product portfolio,” “Based on its known pharmacology, we anticipate that oral administration of SGX201 may help to prevent or reduce the severity of acute radiation enteritis and other inflammatory diseases of the GI tract. This is now the third active clinical trial underway with orBec or oral BDP. We look forward to working with our Medical Advisory Board and investigational sites to complete this important proof of concept study.”