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

News provided by

Nov 26, 2014, 04:00 ET

MONT-SAINT-GUIBERT, Belgium, November 26, 2014 /PRNewswire/ --

Dr Bernard J. Gersh, Dr Thomas Povsic and Dr Gerasimos Filippatos will be Co-Principal Investigators of the phase III clinical trial CHART-2, authorized by the FDA in January
CHART-2 is expected to start by the end of 2014

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 trialis further recognition ofthe 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.

To subscribe to Cardio3 BioSciences' newsletter, visit http://www.c3bs.com.

About CHART-2

CHART-2, the Company's second Phase III clinical trial, is intended to assess in the US, the efficacy of C-Cure® as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is the Six Minute Walk Test post-procedure, a commonly used index of cardiovascular performance.

About C-Cure®

Cardio3 BioSciences' C-Cure® therapy involves taking stem cells from a patient's own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells to become heart cells. The cells, known as cardiopoietic cells, are then injected back into the patient's heart through a minimally invasive procedure, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C-Cure® is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre in Aalst (Aalst, Belgium).

About Mayo Clinic

Recognizing 150 years of serving humanity in 2014, Mayo Clinic is a non-profit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit http://www.150years.mayoclinic.org ; http://www.mayoclinic.org ; and http://www.newsnetwork.mayoclinic.org .

Mayo Clinic has a financial interest in Cardio3 Biosciences.

About Cardio3 BioSciences

Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of unmet medical needs. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium.

The Company's lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient's own cells that are harvested from the patient's bone marrow and engineered to become new heart muscle. This process is known as Cardiopoiesis.

Cardio3 BioSciences has also developed C-Cath_ez®, the most technologically advanced injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.

Cardio3 BioSciences' shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD.

C3BS-CQR-1, C-Cure, C-Cath_ez, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath_ez logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities.

For more information, please contact:
Cardio3 BioSciences
Christian Homsy, CEO
Julie Grade, Corporate Communications Manager
http://www.c3bs.com
Tel. : +32-10-39-41-00
[email protected]

For Europe: Citigate Dewe Rogerson
Chris Gardner
Tel : +44(0)207-638-9571
[email protected]

For the U.S: Rx Communications Group
Eric Goldman
Tel: +1-917-322-2563
[email protected]