Ulcers

August 5, 2013

Pergamum reported results of a phase I/II study of LL-37 in patients with chronic leg ulcers. In the double-blind, multi-center study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37 (0.5mg/ml, 1.6mg/ml and 3.2mg/ml). Top-line results show patients treated with LL-37 for one month experienced an improved healing rate compared to placebo for the two lower doses. The average healing rate in patients receiving 0.5mg/ml or 1.6mg/ml was three to six times higher than in the placebo group, and this difference was statistically significant (p<0.05). The drug was well-tolerated when it was applied to venous leg ulcers at the two lower doses (0.5mg/mL and 1.6mg/mL). However, an increased incidence of local reactions at the treated wounds was observed in the highest dose group (3.2mg/ml) and there was no improvement in wound healing in comparison with placebo.

February 18, 2013

Pozen released results from two phase III trials of PA32540 for the treatment of endoscopic gastroduodenal ulcers. The blinded, randomized, multicenter studies enrolled 1,049 patients with previous cerebrovascular disease, who were prescribed daily aspirin (325mg) for at least three months for secondary prevention of cardiovascular events. Subjects received either once-daily PA32540 or enteric-coated aspirin 325mg. Post-hoc analysis of subjects with a history of transient ischemic attack or stroke, long-term treatment with PA32540, compared to enteric-coated aspirin, was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4%, respectively; p=0.005). Furthermore, 85.1% of subjects on enteric-coated aspirin reported adverse events compared to 71.8% of subjects on PA32540. The drug was well tolerated. The most frequent adverse events were GI tract and include dyspepsia, erosive gastritis and gastritis.