Resverlogix Activates First Site for ASSURE 1 Clinical Trial
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Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has officially activated the first site for the ASSURE 1 trial and commenced enrollment of patients for dosing of RVX-208. ASSURE 1 is the second Resverlogix Phase 2 clinical trial, led by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with acute coronary syndrome (ACS). This preparatory acute coronary syndrome study will ensure that 50 percent of the enrolled patients receive the IVUS (intravascular ultrasound) assessment. The 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, ASSURE 1, an acronym for ApoA-l Synthesis Stimulation in Acute Coronary Syndrome patients. The ASSURE 1 study compliments the ongoing ASSERT trial in patients with stable coronary artery disease.
"For the first time Resverlogix anticipates that it will be able to describe early trends for the relationship between RVX-208 and changes in lipid parameters, changes in measures of atheroma burden and plaque composition," said Dr. Jan O. Johansson, M.D., PhD., Senior Vice President Medical Affairs of Resverlogix. Johansson emphasized, "The unmet medical need in coronary atherosclerosis worldwide is huge. The importance of the reduction of atheroma burden via ApoA-l therapies was highlighted in a recent pharmacoeconomic analysis authored by Destum Partners. Destum's research concluded that by using an ApoA-l increasing therapy in patients as a secondary prevention measure, outcomes could be significantly improved and the potential savings to the US health care system, society, and employers beyond current standard of care are from US $22.9 billion and US $76.8 billion annually, for a 1% to 5% regression of atherosclerosis, respectively."
This IVUS study is comprised of 15-20 US sites will dose approximately 120 ACS patients on standard of care therapy and examine lipid effects by RVX-208 compared to placebo control. In half of the patients a change in atherosclerosis will be assessed, i.e. change in plaque volume and plaque composition. The primary objective of this study is to determine the 3 month effect of RVX-208 on change in the plasma levels of ApoA-l in patients with a recent ACS event who require coronary angiography versus placebo. The secondary objectives for this study include assessing the safety and tolerability of the drug through evaluation of adverse events as well as to evaluate the effect of RVX-208 on other lipid parameters.
"There are a number of people who are very pleased that we are able to announce the beginning of our IVUS study. Much planning has been undertaken with our international experts who reside on our IVUS Steering Committee and Clinical Advisory Committee. We are pleased to be able to bring RVX-208 to acute coronary syndrome patients, a group that presents with high cardiovascular risk," said Dr. Allan Gordon, Senior Vice President Clinical Development of Resverlogix Corp.
"For the first time Resverlogix anticipates that it will be able to describe early trends for the relationship between RVX-208 and changes in lipid parameters, changes in measures of atheroma burden and plaque composition," said Dr. Jan O. Johansson, M.D., PhD., Senior Vice President Medical Affairs of Resverlogix. Johansson emphasized, "The unmet medical need in coronary atherosclerosis worldwide is huge. The importance of the reduction of atheroma burden via ApoA-l therapies was highlighted in a recent pharmacoeconomic analysis authored by Destum Partners. Destum's research concluded that by using an ApoA-l increasing therapy in patients as a secondary prevention measure, outcomes could be significantly improved and the potential savings to the US health care system, society, and employers beyond current standard of care are from US $22.9 billion and US $76.8 billion annually, for a 1% to 5% regression of atherosclerosis, respectively."
This IVUS study is comprised of 15-20 US sites will dose approximately 120 ACS patients on standard of care therapy and examine lipid effects by RVX-208 compared to placebo control. In half of the patients a change in atherosclerosis will be assessed, i.e. change in plaque volume and plaque composition. The primary objective of this study is to determine the 3 month effect of RVX-208 on change in the plasma levels of ApoA-l in patients with a recent ACS event who require coronary angiography versus placebo. The secondary objectives for this study include assessing the safety and tolerability of the drug through evaluation of adverse events as well as to evaluate the effect of RVX-208 on other lipid parameters.
"There are a number of people who are very pleased that we are able to announce the beginning of our IVUS study. Much planning has been undertaken with our international experts who reside on our IVUS Steering Committee and Clinical Advisory Committee. We are pleased to be able to bring RVX-208 to acute coronary syndrome patients, a group that presents with high cardiovascular risk," said Dr. Allan Gordon, Senior Vice President Clinical Development of Resverlogix Corp.
