RXI-109: Additional Phase I data

Data from 3 healthy volunteers in the fourth cohort of the double-blind, placebo-controlled, Honduran Phase I 1202 trial showed that 3 intradermal injections of 10 mg RXI-109 over 2 weeks directly following incision led to a reduction of about 50% in CTGF mRNA from baseline to day 3 after the last dose vs. placebo. Data from the fifth cohort showed that multiple intradermal injections of 10 mg RXI-109 starting 2 weeks following incision led to no additional benefit in CTGF mRNA reduction, but did result in fewer local skin effects. All doses and treatment regimens of RXI-109 were well tolerated.

The trial enrolled 5 cohorts of 3 patients each to receive multiple injections of 2.5, 5, 7.5 or 10 mg RXI-109. Subjects received small skin incisions on their abdomen and were treated with 3 intradermal injections of RXI-109 over a 2-week period. Subjects received RXI-109 on 1 side of the abdomen and placebo on the other side. Last July, RXi reported data from 9 subjects in the trial (see BioCentury, July 29, 2013). ...