Based on these important findings, the Company now plans to adjust its future dosing. Expanded Phase 2 planning is moving forward to include Phase 2 IVUS trials, a Phase 2 dosing trial and a Phase 2 combination statin trial. The IVUS Steering Committee is chaired by Dr. Steven Nissen, Chairman of the Cleveland Clinic Department of Cardiovascular Medicine, and the principal investigator is Dr. Stephen Nicholls, Medical Director of Intravascular Ultrasound at Cleveland Clinic.
"The results we have observed in our second clinical trial illustrate an important emerging pattern of predictability. To date 162 human subjects have received RVX-208 which has consistently demonstrated itself to be a well tolerated and safe therapeutic," stated Dr. Jan Johansson Senior Vice President of Medical Affairs at Resverlogix. "It is important to note that in addition to the increases in ApoA-I and HDL, we also saw very pronounced increases in alpha-1 HDL, another important marker for CVD risk. The landmark Framingham Offspring Study clearly illustrated that among HDL and LDL, alpha-1 HDL was a more critically important marker for CVD protection," Dr. Johansson added.
Developing small molecules that increase ApoA-I would satisfy a huge unmet medical need because CVD treatment with statins, the current standard of care, only stabilizes atherosclerosis and reduces cardiovascular risk by 30%. A recent cost-benefit pharmacoeconomic analysis of ApoA-I therapy for CVD estimated that a 1% and 5% regression of atherosclerosis would save the U.S. health care system and employers between US $22.9 billion and US $76.8 billion annually over and above statin therapy. The analysis assumes ApoA-I therapy will be
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