The final results, expected in August, will be used for an application to the FDA to get permission to conduct a phase II trial of the drug in the US. To date, there have not been any significant adverse events that would jeopardize the submission to the FDA. Forbes anticipates being in a position to seek approval in the third quarter of 2005.
“FM-VP4 has consistently demonstrated a favorable safety profile through previous clinical and pre-clinical studies,” said Charles Butt, president and CEO of Forbes. “The incoming study results provide the opportunity to demonstrate FM-VP4’s continued safety profile over a longer period of time than previous studies and to complete the IND application.”
FM-VP4 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.