Forbes Medi-Tech has initiated its Phase II trial for its cholesterol-lowering drug, FM-VP4. Fifteen U.S. sites have been selected and have begun to identify potentially eligible subjects. The primary efficacy objective of this trial is to determine the effect of two doses of FM-VP4, 450 mg and 900 mg, given for 12 weeks, compared to placebo, on low density lipoprotein-cholesterol (LDL-C). The goal of this trial is to demonstrate a minimum of 15 percent reduction from baseline in LDL-C at Week 12.
The multicenter Phase II trial with 150 male and female mild-to-moderate hypercholesterolemic subjects is randomized, double-blind and placebo-controlled. Subjects will be eligible if they have a LDL-C of 130-210 mg/dL and a triglyceride of less than 300 mg/dL. After the run-in period, patients fulfilling the inclusion criteria will be randomized for the double-blind period. Randomization will be equal across three groups with approximately 50 subjects in each group. The trial is expected to be completed in the third quarter of 2006.