Cardio3 Biosciences announces the nomination of three co-principal investigators for its chart-2 Phase iii clinical trial of C-Cure® for the treatment of heart failure

Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today the appointment of its three Co-Principal Investigators for the CHART-2 study (Congestive Heart Failure cArdiopoietic Regenerative Therapy), authorized in the United States by the FDA in January, and anticipated to start by the end of 2014.

CHART-2 is Cardio3 BioSciences’ second Phase III trial for C-Cure®, the first and only stem cell therapeutic using guided stem cells for the condition of congestive heart failure. C-Cure® is currently in a Phase III clinical trial in Europe (CHART-1). The CHART-2 Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial is designed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure

In a clinical trial, the Principal Investigator (“PI”) is responsible for the scientific and medical supervision of the trial. The PI reviews the protocol, oversees the implementation of the trial at all the investigational sites, and provides guidance as to the integrity and the interpretability of the data generated during the trial.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “Cardio3 BioSciences is very proud to count three such prominent physicians as the Co-Principal Investigators of its phase III clinical study for
C-Cure® authorized in the United States. The medical community is eagerly waiting for a solution for the treatment of heart failure patients, and CHART-2 is a promising avenue towards treating this disease. We selected three prominent cardiologists with established reputations and their acceptance to lead our clinical trial is further recognition of the potential of C-Cure® as future treatment of heart failure.”

Dr Bernard J. Gersh – Professor of Medicine at Mayo Clinic College of Medicine, Rochester, Minnesota, and Consultant in Cardiovascular Diseases and Internal Medicine

Dr Bernard J. Gersh received his MD, Ch.B, from the University of Cape Town in South Africa. He then received his Ph.D from Oxford University where he was a Rhodes Scholar. Dr Bernard J. Gersh is currently Professor of Medicine at Mayo Clinic College of Medicine. Author, co-author and editor of several articles, books and publications about cardiovascular medicine, Dr Gersh has a wide interest in the natural history and therapy of acute and chronic coronary artery disease. In 2014 he was named in the Thomson Reuters list of individuals with the greatest number of cited scientific papers 2002-2012. Dr Gersh is also Chairman of the World Health Organization Cardiovascular Working Group on the 11^th edition of the International Classification of Diseases (ICD) Reclassification.

Dr Thomas Povsic – Associate Professor of Medicine at Duke University, Durham, North Carolina

Dr Thomas Povsic received his Ph.D. in bioorganic chemistry from the California Institute of Technology and his MD at Harvard Medical School. Since 2004, he has been on the faculty of Medicine at Duke University. Dr Povsic has an extensive experience in clinical trials in the field of regenerative medicine, having served as principal investigator on a number of clinical trials for the treatment of cardiovascular diseases as well as in the field of cellular therapies for those diseases. Dr. Povsic brings to the trial leadership team extensive interventional cardiology experience.

Dr Gerasimos Filippatos – Head of the Heart Failure Unit at the Athens University Hospital Attikon, President of the Heart Failure Association of the European Society of Cardiology (ESC)Dr Gerasimos Filippatos received his MD Degree from the University of Patras, Greece. He then obtained his Doctoral Degree in Physiology-Critical Care from the University of Athens. Dr Filippatos is at the head of the heart failure unit at the Department of Cardiology of the Athens University Hospital. He has been Chairman of the Clinical Section as well as of the Committee on Acute Heart Failure of the Heart Failure Association of the ESC and member of the Practice Guidelines Committee. An expert in heart failure and acute coronary syndromes, Dr Filippatos has written extensively on the subject in several publications and scientific journals. Dr Filippatos brings world-class heart failure expertise to the trial leadership team.

C-Cure®, Cardio3 BioSciences’ candidate therapy, is currently in a Phase III clinical trial in Europe (CHART-1). The second Phase III trial CHART-2, authorized in the U.S. by the FDA, is a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial is designed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.