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news.Forbes Medi-Tech has commenced a 90-day toxicity study for its cholesterol-lowering drug, FM-VP4, which is required to support an extended US phase II human trial planned for later this year.
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Results from an earlier 28 day European trial of FM-VP4 suggest that LDL cholesterol, or “bad” cholesterol, levels may continue to decrease when FM-VP4 is given to patients for longer than four weeks and that optimal efficacy may not have been achieved.
“The toxicity study is an important precursor to our US phase II trials for FM-VP4 and an opportunity to further demonstrate the drug’s positive safety profile,” said Charles Butt, president and CEO of Forbes Medi-Tech. “An excellent safety profile represents a distinct advantage in potential therapies for cardiovascular and related diseases.”
FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs, and has demonstrated dramatic cholesterol-lowering and anti-atherosclerotic properties in preclinical studies.
According to Datamonitor research, the cardiovascular market represents a significant opportunity, as sales of cardiovascular pharmaceuticals are expected to exceed $30 billion by 2007.