December 23, 2009 – The Cleveland Clinic this week initiated a phase II trial examining a new oral therapy for the treatment of atherosclerosis in patients with stable coronary artery disease (CAD).
The trial is using the investigational drug RVX-208 from Resverlogix Corp. The new small-molecule therapeutic facilitates endogenous ApoA-I production, thereby raising HDL levels to help reverse cholesterol transport (RCT). RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, which prevents atherosclerosis.
The ASSERT (ApoA1 Synthesis Stimulation Evaluation in patients Requiring Treatment for coronary artery disease). A total of 40 investigator sites across the United States will be participating in the study.
“I am pleased to see the start of this 18 week randomized, outpatient multicenter, double-blind, placebo-controlled study that will administer RVX-208 to approximately 280 patients with stable CAD for 13 weeks,” said Stephen J. Nicholls, MBBS, Ph.D., medical director of the atherosclerosis imaging core laboratories at Cleveland Clinic and cardiovascular director of the Cleveland Clinic coordinating center for clinical research. “This trial is one of two parallel studies, in this particular study the focus is on stable CAD patients, while the second trial will be focused on unstable acute coronary syndrome and will include the use of intravascular ultrasound (IVUS).”
The primary objective of this study is to determine if RVX-208 will produce an increase in plasma ApoA-l levels compared to placebo group after three months of dosing. The secondary objectives are to examine the safety and tolerability of RVX-208, to compare the dose and time response relationships for ApoA-l over time as well as to examine and key reverse cholesterol makers such as alpha 1 HDL.
For more information: www.resverlogix.com