Cardio3 BioSciences Receives Authorization to Begin World's First Phase III Clinical Trial in Regenerative Medicine for Heart Failure

MONT-SAINT-GUIBERT, Belgium, November 22, 2012 /PRNewswire/ --

The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces it has received authorization from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium. This represents a world premiere for a regenerative medicine product targeting heart failure to be tested in the context of a Phase III trial. C3BS-CQR-1 is an autologous stem cell therapy for heart failure.

The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C3BS-CQR-1 to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.  The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure.  

Studies in additional countries will commence once national regulatory approvals have been received.

The Cardio3 BioSciences therapy, called C3BS-CQR-1, involves taking stem cells from a patient's own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells so that they go onto becoming heart cells. The cells, known as cardiopoietic cells, are then injected back into the patient's heart through a minimally invasive procedure using a catheter called C-Cath_ez^®, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C3BS-CQR-1 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). This Phase III trial builds on the successful outcome of the Phase II trial conducted between 2009 and 2010 in multiple clinical sites in Belgium, Serbia and Switzerland.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: "Heart failure remains a significant unmet clinical need associated with high morbidity, mortality and escalating healthcare costs. We believe C3BS-CQR-1 has a potential to become an alternative to heart transplantation which is the only curative treatment for heart failure available today. Our Phase III trial is the first to begin anywhere in the world for a regenerative therapy for this indication. We look forward to confirming the promising results we have already seen in our Phase II study."

Dr Jozef Bartunek, Principal Investigator, added: "Regenerative therapies have the potential to revolutionize the treatment of heart disease and other conditions and we are excited to be working with Cardio3 BioSciences on what is a ground breaking study. The results seen in the earlier trials were encouraging and if repeated in this larger study would bring nearer a potentially disruptive treatment for the expanding epidemic of heart failure."

Cardio3 BioSciences has completed a Phase II trial with C3BS-CQR-1, which demonstrated that heart failure patients improved heart function and exercise capacity following treatment compared to patients receiving current standard of care. Moreover, feasibility and safety of the C3BS-CQR-1 treatment regimen were established.

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 cardiac diseases. 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 C3BS-CQR-1 is an innovative pharmaceutical product that is being developed for heart failure indication.  C3BS-CQR-1 consists of a patient's own cells that are harvested from the patient's bone marrow and engineered to become new heart muscle cells that behave identically to those lost to heart disease. This process is known as Cardiopoiesis.

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

C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath 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. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements.  We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information contact:
Cardio3 BioSciences
Dr Christian Homsy, CEO
Anne Portzenheim, Communication Manager
www.c3bs.com
Tel : +32-10-39-41-00
aportzenheim@c3bs.com

Citigate Dewe Rogerson
Chris Gardner/Nina Enegren
Tel : +44(0)207-638-9571
nina.enegren@citigatedr.co.uk

Hill & Knowlton
Katia Delvaille
Tel : +32-2-737-95-00
katia.delvaille@hkstrategies.com