Resverlogix Commences Phase 2 Atherosclerosis Clinical Trial
News Dec 24, 2009
Resverlogix Corp. has announced that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).
This study is chaired by Dr. Steven Nissen, MD, Chairman of the Cleveland Clinic Department of Cardiovascular Medicine and the principal investigator is Dr. Stephen Nicholls, Medical Director of Intravascular Ultrasound at Cleveland Clinic.
The Cleveland Clinic has named this trial, ASSERT, which stands for ApoA1 Synthesis Stimulation Evaluation in Patients Requiring Treatment for Coronary Artery Disease. A total of 40 investigator sites across the US 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 Dr. Stephen J. Nicholls, MBBS, PhD, 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)."
Cardiovascular disease is the leading cause of death in the US and other developed nations costing the American health care system an estimated $448.5 billion in 2008. A key underlying cause of cardiovascular disease is atherosclerosis, a build-up of plaque in the arteries often referred to as 'hardening of the arteries'.
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.