Cardio3 BioSciences has announced it has received authorisation from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its CHART-1 (Congestive heart failure cardiopoietic regenerative therapy) European phase III trial for C3BS-CQR-1, an autologous stem cell therapy for heart failure, in Belgium.
The phase III trial is a prospective, multicentre, randomised, 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 nine months post-procedure.
The company announced that studies in additional countries will commence once national regulatory approvals have been received.
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, USA), Cardio3 BioSciences and Cardiovascular Centre in Aalst (Aalst, Belgium). This phase III trial builds on the positive outcome of the phase II trial conducted between 2009 and 2010 in multiple clinical sites in Belgium, Serbia and Switzerland. The phase II trial demonstrated improvement in heart function and exercise capacity in heart failure patients following treatment compared to patients receiving current standard of care.
“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,” saidChristian Homsy, CEO, Cardio3 BioSciences.
“Regenerative therapies have the potential to revolutionise 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,”said Jozef Bartunek, principal investigator of the study.