Date: 2014-11-12
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: CSL (Australia)
Product: CSL112
Action
mechanism: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I), the primary functional component of high-density lipoprotein (HDL). It is purified from human plasma and reconstituted to form HDL particles suitable for intravenous infusion. Studies have shown that the infusion of CSL112 rapidly elevates markers of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance. CSL112 may offer a novel option for rapidly stabilizing atherosclerotic lesions and is being studied for reduction in the risk of early atherothrombotic events in acute myocardial infarction patients.
Disease: coronary heart disease
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: AEGIS-I is a Phase 2b, global, randomized, placebo-controlled, dose-ranging study investigating the safety and tolerability of multiple dose administration of CSL112 in 1,200 patients who experienced an acute myocardial infarction or heart attack. Secondary outcome measures include time-to-first occurrence of a major adverse cardiovascular event (MACE) defined as cardiovascular death, myocardial infarction (MI), ischemic stroke and hospitalization for unstable angina. Results of the study are expected in 2016.i
Latest
news: * On November 12, 2014, CSL announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly infusions, CSL112 is designed to rapidly remove cholesterol from the arteries and stabilize lesions at risk of rupture. This represents a new approach to reduce the high incidence of early recurrent cardiovascular events in the days and weeks following a heart attack. AEGIS-I will also allow CSL to select the dose to take into the phase 3 outcomes trial where the company will test the hypothesis that rapid removal of cholesterol with CSL112 will stabilize plaque and thereby reduce the incidence of early recurrent cardiovascular events.
