06.21.11
Following pre-clinical results for its PRC-4016, a new chemical entity for the treatment of mixed dyslipidemia, Norway-based Pronova BioPharma is preparing to initiate clinical trials. PRC-4016 is a structurally enhanced omega 3 fatty acid with potent triglyceride and cholesterol-lowering effects.
Mixed dyslipidemia is one of three main types of dyslipidemia, which is caused by an imbalance in the level of blood lipids. Lipids, or fat molecules, include both cholesterol and triglycerides, and dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. Mixed dyslipidemia is characterized by elevated triglycerides (TG) and low high-density lipoprotein-cholesterol (HDL-C) with or without raised LDL cholesterol. The prevalence of dyslipidemia across the seven major pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40%.
Pronova BioPharma is preparing to submit a CTA (Clinical Trial Application) for PRC-4016 in Europe, with the first patients expected to be dosed in September 2011. The Phase I trial will involve 80-120 subjects and be conducted in the U.K. PRC-4016 will be tested in single and multiple escalating doses. Phase II studies are expected to begin in 2012.
Mixed dyslipidemia is one of three main types of dyslipidemia, which is caused by an imbalance in the level of blood lipids. Lipids, or fat molecules, include both cholesterol and triglycerides, and dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. Mixed dyslipidemia is characterized by elevated triglycerides (TG) and low high-density lipoprotein-cholesterol (HDL-C) with or without raised LDL cholesterol. The prevalence of dyslipidemia across the seven major pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40%.
Pronova BioPharma is preparing to submit a CTA (Clinical Trial Application) for PRC-4016 in Europe, with the first patients expected to be dosed in September 2011. The Phase I trial will involve 80-120 subjects and be conducted in the U.K. PRC-4016 will be tested in single and multiple escalating doses. Phase II studies are expected to begin in 2012.