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news.Forbes Medi-Tech has started dosing subjects in a US phase II trial for its cholesterol-lowering drug, FM-VP4.
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FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs. The drug may have an application as a monotherapy or as a combination therapy with statins.
Combination therapies allow for a lower statin dose, which may reduce the risk of side effects. According to Datamonitor research the statin combination market is expected to grow at a compound annual rate of 44%, reaching $4.7 billion by 2011.
The trial will randomize 150 male and female mild to moderate hypercholesterolemic subjects into three groups of approximately 50.
The primary efficacy objective of this trial is to determine the effect of two doses of FM-VP4, 450mg and 900mg, given for 12 weeks, compared to placebo, on low density lipoprotein-cholesterol (LDL-C).
The company’s goal for the trial is for the drug to demonstrate a minimum of 15% reduction from baseline in LDL-C at week 12. The trial is expected to be completed in the third quarter of 2006.
“Dosing is a major step forward in the clinical process,” said Charles Butt, president and CEO of Forbes Medi-Tech.