Enrollment complete in SUSTAIN Phase 2b clinical trial for atherosclerotic CVD

Nov 28 2011

Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that SUSTAIN, a Phase 2b clinical trial comprised of 176 subjects, is fully enrolled. The Cleveland Clinic leads this trial in which all subjects have established atherosclerotic cardiovascular disease (CVD) and low high-density cholesterol (HDL-C). In SUSTAIN, all subjects will receive standard of care therapy that includes up to 40 mg atorvastatin (Lipitor) or 20 mg rosuvastatin (Crestor).  Despite the standard of care therapy in the SUSTAIN population, the risk of recurrent CVD events remains exceedingly high. Thus this patient population presents an ideal opportunity to test the effects of placebo vs. RVX-208 (200 mg/day) an orally active small molecule that raises ApoA-I production and thereby increases HDL-C. SUSTAIN is a 24-week, multi-center, double-blind, randomized, parallel group, placebo controlled clinical trial to assess lipid trends and safety of RVX-208.  Additionally, other biomarkers of reverse cholesterol transport (RCT) will be examined.  The primary endpoint of SUSTAIN is the change in HDL-C from baseline after receiving RVX-208 for 24 weeks vs. placebo. Secondary endpoints include change in ApoA-I, LDL-C, non-HDL-C, apoB, TG and HDL subclasses. Resverlogix expects top line data by late 2012.

"The speed of patient enrollment for SUSTAIN has exceeded our expectations," stated Donald McCaffrey, President and Chief Executive Officer of Resverlogix. "The important goals in SUSTAIN are to show safety and lipid altering effects of RVX-208 in subjects with atherosclerotic CVD and low HDL-C given standard of care therapies. Results from SUSTAIN will help to identify a patient population that will likely benefit the most from the actions of RVX-208 on atherosclerotic CVD", Mr. McCaffrey further commented.