FORBES MEDI-TECH SUBMITS APPLICATION FOR CHOLESTEROL-LOWERING DRUG

Forbes Medi-Tech has submitted an investigational new drug application to the FDA to initiate a Phase II clinical trial for its cholesterol-lowering drug, FM-VP4. The application provides the FDA with clinical and preclinical safety and manufacturing data in support of clinical evaluation of FM-VP4 in humans.

The design of the upcoming trial incorporates the knowledge gathered from both preclinical studies and a European proof of concept trial in humans. The planned trial includes enhancements to the dosing regime, length of trial and patient population with an end target of 15 percent reduction in LDL-cholesterol.