Resverlogix Corp. has announced the formation of an international Clinical Steering Committee for the RVX-208 "apabetalone" Phase 3 clinical trial BETonMACE assessing major adverse cardiac events (MACE) in high-risk vascular patients with diabetes mellitus and a recent Acute Coronary Syndrome event. BETonMACE is expected to start in the fall of 2015.
Members of the Phase 3 BETonMACE Clinical Steering Committee include:
Chairman: Kausik K. Ray, BSc (hons), MBChB, MD, MPhil (Cantab), FACC, FAHA, FESC, FRCP
Kausik K. Ray is Professor of Public Heath, Department of Primary Care and Public Health, School of Public Health, Imperial College London, UK. Professor Ray's research interests focus on the prevention of cardiovascular disease using observational methods and intervention studies including large trials. Recently Professor Ray has established the first global registry of Familial Hypercholesterolaemia in conjunction with the European Atherosclerosis Society (EAS) called the FH studies collaboration (FHSC) and is PI for the TOGETHER study looking at cardiometabolic risk factors and clinical outcomes in approximately 250,000 people using electronic health records in London.
Henry N. Ginsberg, MD, FAHA
Henry N. Ginsberg is the Irving Professor of Medicine at Columbia University College of Physicians and Surgeons, Associate Dean for Clinical and Translational Research, and Director of the Irving Institute for Clinical and Translational Research at Columbia University Medical Center. Dr. Ginsberg's research focuses on the regulation of lipoprotein metabolism, particularly in relation to insulin resistance and diabetes. He has published over 230 peer-reviewed articles. He was the Principal Investigator in the landmark ACCORD Lipid Trial.
Kamyar Kalantar-Zadeh, MD, MPH, PhD, FAAP, FACP, FASN, FAHA, FNKF
Kam Kalantar-Zadeh is a Professor of Medicine, Pediatrics, Public Health and Epidemiology, and Chief of the Division of Nephrology and Hypertension at UC Irvine School of Medicine. Dr. Kalantar's research focuses on kidney disease outcomes and cardiovascular risks in CKD and diabetes. Dr. Kalantar has authored or coauthored over 400 peer reviewed research articles and scientific papers and 15 book chapters. He is the President Elect of the International Society of Renal Nutrition and Metabolism, and an Associate Editor of several journals including the American Journal of Kidney Diseases and Nephrology Dialysis Transplantation.
Stephen J. Nicholls, MBBS, PhD
Stephen J. Nicholls is Professor of Cardiology at the University of Adelaide and Deputy Director at the South Australian Health and Medical Research Institute. Dr. Nicholls has published more than 500 original medical and scientific manuscripts, conference proceedings and book chapters. He is the Principal Investigator of the SATURN, AQUARIUS, ACCELERATE, STRENGTH and GLAGOV trials. He is a fellow of the Royal Australasian College of Physicians and American College of Cardiology and a member of the American Heart Association.
Gregory G. Schwartz, MD, PhD
Gregory G. Schwartz is Professor of Medicine in the Division of Cardiology of the University of Colorado Denver. Dr. Schwartz has been the lead investigator in global trials in acute coronary syndrome including MIRACL (atorvastatin), dAL-OUTCOMES (dalcetrapib), and ODYSSEY Outcomes (alirocumab). Dr. Schwartz is a fellow of the American Heart Association and the American College of Cardiology and a member of the American Physiological Society and the International Society for Heart Research.
Peter P. Toth, MD, PhD, FAAFP, FICA, FAHA, FNLA, FCCP, FACC
Peter P. Toth is the Chief of Medicine for CGH Medical Center and Clinical Professor at the University of Illinois School of Medicine and associate Professor of Medicine at Johns Hopkins University School of Medicine. Dr. Toth has authored and coauthored over 220 publications in medical and scientific journals and textbooks. Dr. Toth is a member of the American College of Cardiology Foundation Council on Cardiovascular Disease Prevention and the American Heart Association's Council on Lipoproteins, Lipid Metabolism, and Thrombosis.
"This is a very significant step for the Company and we are honored to have an experienced and highly esteemed group of internationally recognized cardiologists, nephrologists, and endocrinologists to lead this important MACE reduction study," stated Mr. Donald J. McCaffrey, president and chief executive officer of Resverlogix. "Select BET inhibition has been observed in our past Phase 2 studies to reduce MACE over short duration of treatment of up to 26 weeks. We will now test the hypothesis that longer treatment of RVX-208, "apabetalone" in a larger number of high-risk vascular patients will improve multiple risk pathways and as a consequence hopefully reduce MACE."
The role of the Clinical Steering Committee (CSC) is to advise on the trial design, provide overall supervision of the trial and ensure that it is being conducted in accordance with the principles of Good Clinical Practice. The CSC has oversight on protocol, any protocol amendments and to provide advice to the investigators on all aspects of the trial.