Cardio3 BioSciences Announces the Nomination of Three Co-Principal Investigators for Its CHART-2 Phase III Clinical …

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.

*** END ***

To subscribe to Cardio3 BioSciences newsletter, visit http://www.c3bs.com. Follow us on Twitter @Cardio3Bio.

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 patients 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 patients 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 Cardio3BioSciences 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. Cardio3BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium. The Companys lead product candidate C-Cure is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure consists of a patients own cells that are harvested from the patients bone marrow and engineered to become new heart muscle. This process is known as Cardiopoiesis. Cardio3BioSciences has also developed C-Cathez, 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-Cathez, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cathezlogos 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.

Link:
Cardio3 BioSciences Announces the Nomination of Three Co-Principal Investigators for Its CHART-2 Phase III Clinical ...