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February 20, 2012
Soligenix issued preliminary results from a phase I/II trial of SGX201, a time-release formulation of oral beclomethasone dipropionate, for the prevention of acute radiation enteritis. This multicenter, open-label, sequential, dose-escalation study, dubbed BDP-ENT-01, enrolled 16 subjects with rectal cancer who were scheduled to undergo concurrent radiation and chemotherapy prior to surgery. The subjects received 1, 2, 3 or 4mg of SGX201 three times daily, with dosing administered throughout the duration of radiation therapy plus one week. Oral administration of SGX201 was safe and well tolerated across all four dose groups. There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis. The incidence of diarrhea was lower than that seen in historical control data.
March 2, 2009
Optimer reported positive results from a phase III trial of Prulifloxacin for the treatment of bacterial gastroenteritis (travelers diarrhea). This randomized, double-blind, placebo-controlled study, dubbed OPT-099-002, enrolled 373 adult subjects who were traveling through India, Guatemala or Mexico and diagnosed with bacterial gastroenteritis. The subjects received either 600mg of oral Prulifloxacin or placebo, once daily over three days. The primary efficacy endpoint was Time to the Last Unformed Stool, defined as the time in hours from the first dose of study medication to the passage of the last unformed stool (TLUS). Prulifloxacin was statistically superior to placebo in TLUS in both the modified intent-to-treat population (n≡200) and microbiologically evaluable population (n≡173). The median TLUS for the Prulifloxacin treatment arm was 32.8 hours; (p-value of <0.0001 versus placebo). Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo.