Forbes Medi-Tech Inc., a biopharmaceutical company dedicated to the research, announced preliminary results of the Phase II clinical trial of the company's cholesterol-lowering compound, FM-VP4, completed at the Academic Medical Centre in Amsterdam. The trial's primary efficacy endpoint of significantly lowering low density lipoprotein (LDL) cholesterol was met. The reduction in LDL cholesterol, as compared to placebo, was 11 per cent, with 33 per cent of subjects at 400 mg per day achieving a greater than 15 per cent reduction. Additionally, FM-VP4 continued to demonstrate an excellent safety profile with no difference between dosing and placebo groups.
"With these results, we are encouraged to pursue our program to develop an adjunctive therapy to statins," said Charles Butt, president & CEO of Forbes Medi-Tech Inc. "The market for this type of combination therapy is projected to reach $4.7 Billion in 2011."
"The Phase II trial produced statistically significant results, which establishes that the compound lowers cholesterol," said Dr. Eric Topol, chairman, Department of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic Foundation. "Forbes Medi-Tech needs to move forward with the further development of FM-VP4 to ascertain the drug's full potential. In particular, additional trials will be required to explore the drug's optimum dose and duration. I am looking forward to working with Forbes on the next phase of its clinical development program".
The trial was the first human examination, on a limited scale, of the safety and efficacy of FM-VP4 over a 4 week interval. The double blind placebo controlled dose escalation trial consisted of four groups of 25 hypercholesterolemic volunteers treated daily for 28 days with either a placebo or escalating doses of FM-VP4 from 100, 200, 400, and 800 mg per day. A desired effect of FM-VP4 in the Phase II trial was a reduction in LDL cholesterol from the baseline measurement after four weeks of treatment.
The company plans to continue a Phase II program in the United States. Plans for this program include an expanded number of participants, a longer trial duration and a more focused dosage range.
FM-VP4, an amphipathic (water and lipid-soluble) analogue of phytostanols is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs. FM-VP4 has demonstrated dramatic cholesterol-lowering and anti-atherosclerotic properties in pre-clinical studies. The cardiovascular market represents a significant opportunity as sales of cardiovascular pharmaceuticals are expected to exceed US$30 billion by 2007. (Datamonitor, March 2001)