Pivotal Therapeutics Inc. announced the publication of results of a prospective randomized controlled trial in the U.S. that evaluated the effects of VASCAZEN® in the correction of Omega-3 deficiency in patients with one or more risk factors associated with CVD and evaluated VASCAZEN®'s concomitant effects on these risk factors including triglycerides, VLDL cholesterol, LDL cholesterol, and HDL cholesterol. Of the 655 patients screened 89% were Omega-3 deficient. The VASCAZEN®-REVEAL trial was the first to determine levels of Omega-3 in plasma and in red blood cells using the Omega-Score and Omega-Index diagnostics.

Omega-Score measures blood levels of EPA, DHA and DPA and Omega-Index measures EPA and DHA in red blood cells. VASCAZEN® was demonstrated to be highly effective in correcting an Omega-3 deficiency in CVD patients with normal and high triglycerides. In eight weeks of treatment with 4 capsules/day of VASCAZEN® there was a 121% improvement in the Omega-Score and 112% improvement in Omega-Index in CVD patients with hypertriglyceridemia (200-500 mg/dL).

The VASCAZEN® formulation had a profound effect on correcting an Omega-3 deficiency and positive effect on lipid profiles, mainly the reduction of triglycerides and raising HDL in as little as eight weeks of treatment. Treatment with VASCAZEN® was associated with a 48% reduction in triglycerides, a 30% reduction in VLDL-C and a 9% increase in HDL-C without adversely affecting LDL-C in patients with hypertriglyceridemia. The safety profile of VASCAZEN® was similar to placebo with no treatment related serious adverse events reported in the trial.