Resverlogix Corp. 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 key reverse cholesterol markers such as Alpha 1 HDL.
“The initiation of the ASSERT Trial is another important milestone that Resverlogix has achieved this year. Our clinical trials to date have produced very encouraging results for our lead drug, RVX- 208, for the treatment of atherosclerosis. Currently, there is a void in therapies that can regress atherosclerosis. The current standard of care is statin therapies, which can only stop atherosclerosis from progressing but in almost all cases is unable to remove it. If RVX-208 is able to achieve this goal it would be an important step toward the reduction of disease risk and lower health system costs. We are delighted to have this trial dose its first patients two months ahead of schedule,” said Donald J. McCaffrey, president and CEO of Resverlogix.
RVX-208, a novel small molecule therapeutic that facilitates endogenous ApoA-I production, is positioned to be one of the most promising emerging drugs in the treatment of atherosclerosis. To the Company’s knowledge RVX-208 is the only novel small molecule that is specifically designed to increase ApoA-I production and thereby raise HDL levels thus enhancing HDL functionality to augment reverse cholesterol transport (RCT). RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus preventing atherosclerosis.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs.