Cardiology

Mont-Saint-Guibert, Belgium, November 22, 2012 –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-Cathez ® , 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. 

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Innovative Heart-Specified Stem Cell Therapy Opens a New Chapter in Cardiovascular Regenerative Medicine

Mont-Saint-Guibert, Belgium, May 16, 2011 – The Belgian biotechnology company, Cardio3 BioSciences, a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, will present Phase II clinical trial data of the flagship product C3BS-CQR-1 (C-Cure®), at the EuroPCR Meeting in Paris on Wednesday, 18th May. This is the First-in-man use of lineage specified stem cells for the treatment of heart failure.

On behalf of the C-Cure international program, data will be presented by Dr. Dariouch Dolatabadi, Civil Hospital, Charleroi, Belgium and Investigator of the C3BS-CQR-1 (C-Cure) trial.

The trial demonstrates that heart failure patients improved heart function and exercise capacity at 6 months following treatment of C-Cure, an innovative stem cell therapy based on the Company’s “Cardiopoiesis” proprietary technology. Moreover, feasibility and safety of the C-Cure treatment regimen were established.

Data strongly suggest that C-Cure is a promising treatment for heart failure, one of the world’s greatest unmet medical needs. A person living to the age of 40 has a one-in-five risk of developing heart failure and, once the disorder is apparent, a one-in-three chances of dying within a year of diagnosis. 

More detailed information on www.c3bs.com/fr/products-pipeline/clinical.html

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Innovative Heart-Specified Stem Cell Therapy Improves Heart Function and Fitness in Heart Failure Patients

• C-Cure is the next generation heart-specified regenerative product developed from the patients’ own bone marrow cells to enable heart repair
• At 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care
• C-Cure therapy improved heart function with an increase in left ventricular ejection fraction of 18.1%

Mont-Saint-Guibert, Belgium, April 5, 2011 – The Belgian biotechnology company, Cardio3 BioSciences, a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today revealed detailed data from the Phase II clinical trial of its novel stem cell therapy for heart failure, C3BS-CQR-1 (C-Cure®), at the 60th annual American College of Cardiology in New Orleans, USA. This newest innovation builds on a proprietary “cardiopoietic platform”, and the ongoing collaborations with investigators at Mayo Clinic and Aalst Cardiovascular Center.

The clinical study was presented by Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C-Cure trial. The results show that, beyond existing best standard of care, patients saw improvements in heart function and exercise capacity when treated with C-Cure. This novel stem cell therapy involves taking a patient’s own bone marrow stem cells and guides them to repair heart tissue when introduced into a damaged heart area.

Heart failure affects over 117 million people worldwide, and cannot be cured today by currently available therapies. Regenerative therapies, such as C-Cure, offer the potential of a lifesaving treatment providing choice to patients with limited options and potentially avoiding the need for heart transplantation.

The Phase II trial recruited 45 patients with severe heart failure of ischemic origin in Belgium and Serbia who were treated with optimal standard of care (Control group) or optimal standard of care plus C-Cure (C-Cure group). 

Patients receiving C-Cure saw an 18.1% increase in left ventricular ejection fraction (LVEF), a measure of heart function, over baseline, as measured by echocardiography, while the mean LVEF improved only marginally in patients enrolled in the control group. This difference in LVEF between the C-Cure treated and control patients was significant (p

Importantly, signs of functional heart improvement were supported by improved fitness, shown by a clinically meaningful mean difference in the 6-minute walking distance test between the C-Cure treatment and control groups. After 6 months, patients treated with C-Cure were able to walk an average of 52 metres further in six minutes whereas control patients treated with current optimal standard of care were able to walk 21 metres less on average. The difference of 73 meters between both groups suggests heart failure patients treated with C-Cure could expect to return to a more active lifestyle, as they recover their ability to perform daily activities.

Dr. Jozef Bartunek explained: “Data presented today strongly suggest that C-Cure is a promising treatment for heart failure, one of the world’s greatest unmet medical needs. A person living to the age of 40 has a one-in-five risk of developing heart failure and, once the disorder is apparent, a one-in-three chances of dying within a year of diagnosis. With the C-Cure trial, we show improved left ventricular and clinical performance consistent with a generalized therapeutic benefit. Moreover, we proved feasibility and safety of the C-Cure treatment regimen. The overall signs of efficacy in C-Cure treated patients are indeed encouraging and open a new chapter in cardiovascular regenerative medicine.”

Dr. Christian Homsy, CEO of Cardio3 BioSciences, added: “We are very pleased to be presenting this important data at one of the most prestigious cardiology conferences. The positive outcome of the C-Cure study reiterates our belief that C-Cure treatment using heart-specified stem cells can make a real difference to patients suffering from heart failure. We are currently planning the next stages of product development, and are committed to taking the steps needed to successfully bring this new and important treatment to patients with heart failure, a condition where current therapies do not address the underlying cause of disease.”

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