Carotid Artery Disease

September 4, 2017

Amgen announced results from an exploratory virtual histology sub-study of the Repatha (evolocumab) GLAGOV phase III coronary intravascular ultrasound imaging trial that looked at coronary artery plaque composition. GLAGOV was a multicenter, double-blind, randomized, placebo-controlled trial designed to evaluate the effect of Repatha on the change in burden of coronary artery disease (CAD) in 968 patients undergoing clinically indicated coronary angiogram and on optimized background statin therapy. This sub-study included 331 patients enrolled in the GLAGOV trial and explored whether Repatha produced changes in individual plaque components (dense calcium, fibrous, fibrofatty, necrotic core) compared to placebo using virtual histology. Patients in the Repatha arm experienced a +1.0mm3 absolute change in the primary endpoint of normalized dense calcium volume from baseline at week 78, compared to +0.6mm3 in the placebo arm (p=0.49). For the secondary endpoint of absolute change in normalized volume of fibrous, fibrofatty and necrotic core plaque measures, patients in the Repatha arm experienced an absolute change of -3.0mm3 versus -2.4mm3 in the placebo arm (p=0.49), -5.0mm3 versus -3.0mm3 (p=0.49) and -0.6mm3 versus -0.1mm3 (p=0.49), respectively, from baseline to week 78.

August 11, 2014

Taxus Cardium Pharmaceuticals Group reported results of a phase III study of Generx Ad5FGF-4 for myocardial ischemia due to coronary artery disease. The 100 subject, randomized, multi-center, controlled study has two parallel arms (Generx and control) being conducted at medical centers in the Russian Federation. At eight weeks, Generx treatment resulted in a 24% improvement in reversible perfusion defect size (RPDS), a statistically significant response compared to the control group (p=0.01, n=11). The observed improvement in RPDS with Generx in the ASPIRE trial is consistent with RPDS improvement previously reported in the Generx AGENT phase II clinical study (n=52). Furthermore, the improvements in RPDS reported in both the ASPIRE and AGENT clinical studies are similar in magnitude to large vessel revascularization procedures, either bypass surgery or angioplasty (PCI), involving the right coronary artery (RCA), the left anterior descending artery (LAD) and the left circumflex artery (LCx), as reported in patients undergoing these procedures.