Resverlogix RVX-208 exceeds expectations in Phase 1b/2a clinical trial

Oct 1 2009

Powerful effects seen in all subjects including those with low HDL - representing a majority of myocardial infarct patients

Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that results from the Company's Phase 1b/2a clinical trial have met and exceeded expectations by successfully concluding the drug, RVX-208, is safe and tolerable. Most importantly RVX-208 has met its primary endpoint to increase the production of plasma ApoA-I, the key cardioprotective protein in high-density lipoprotein (HDL), often referred to as "good" cholesterol. ApoA-I is generally endorsed as a key protective factor against atherosclerosis and cardiovascular disease with 40% of all first heart attack patients having low ApoA-I.

Resverlogix's Phase 1b/2a study tested RVX-208 for 28 days in three different dosing arms. The most pronounced results were demonstrated among those subjects with low HDL cholesterol levels. Low HDL is an important risk factor in coronary and cardiovascular disease patients. Resverlogix will continue to build upon its world leading position in development of novel small molecules that increase ApoA-l production and reverse cholesterol transport (RCT) markers in patients with high vascular risk profiles. RCT is a path by which cholesterol on the arterial wall is transported back to the liver by ApoA-I lipid complexes for excretion. Additional analysis was performed on other key RCT markers which achieved high levels of statistical significance. The Company has established a dosing range that it deems will be safe, well tolerated and effective for Phase 2 intravascular ultrasound (IVUS) development trials.

"The range of increase in ApoA-l production of all subjects, but in particular low HDL subjects over placebo demonstrated in this study is one of the most significant pieces of data for RVX-208. We have exceeded our original expectation for enhancing ApoA-l production in humans," stated Donald J. McCaffrey, President and CEO of Resverlogix. "We know that the enhancement of ApoA-l and key RCT particles in the body is widely recognized by international experts as the necessary markers to potentially impact atherosclerosis regression. Hence, we have achieved another critically important clinical milestone for our Company," noted McCaffrey.

The Phase 1b/2a trial was a double blind safety and tolerance study which investigated the pharmacokinetics and also early pharmacodynamics effects of RVX-208. A total of 72 subjects enrolled in the trial. The study had three arms, a low dose arm with 24 subjects, a dose-escalation arm with 24 subjects, and a third high dose arm with 24 subjects. This trial also examined early markers for reverse cholesterol transport such as ApoA-l, HDL-c, pre-beta HDL and alpha HDL subparticles. Approximately half of the subjects had low levels of baseline HDL cholesterol.