Forbes Medi-Tech begins phase 2 trial of cholesterol-lowering drug FM-VP4

By Angela McDaniels

Seattle, Dec. 2 - Forbes Medi-Tech Inc. said it has started dosing subjects in a U.S. phase 2 trial for its cholesterol-lowering drug FM-VP4.

The primary efficacy objective of this trial is to determine the effect of two doses of FM-VP4, 450mg and 900mg, on low-density lipoprotein-cholesterol (LDL-C). The trial goal is to demonstrate a minimum 15% reduction from baseline in LDL-C at week 12.

The multi-center, randomized, double-blind and placebo-controlled trial has enrolled 150 subjects with mild to moderate hypercholesterolemia: LDL-C of 130-210 mg/dL and a triglyceride of less than 300 mg/dL.

The trial will also evaluate safety, tolerability and the effects of FM-VP4 on total cholesterol, high-density lipoprotein-cholesterol (HDL-C), HDL to LDL ratio, triglycerides and C-reactive protein.

The trial is expected to be completed in the third quarter of 2006, the company said.

FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drug, the company said. It may have an application as a monotherapy, an adjunct therapy or, perhaps even more importantly, as a combination therapy with statins.

Combination therapies are significant, as they allow for a lower statin dose, which in turn may reduce the risk of side effects, the company said. According to Datamonitor, the statin combination market is expected to grow at a compound annual rate of 44%, reaching $4.7 billion by 2011. Sales of cardiovascular pharmaceuticals are estimated to grow to more than $40 billion in the same period.

Forbes Medi-Tech is a Vancouver, B.C.-based life sciences company that develops products for the prevention and treatment of cardiovascular disease.

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