Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) presented detailed data from the Phase II clinical trial of C3BS-CQR-1 (“C-Cure”), a novel stem cell therapy for ischemic cardiomyopathy, at the recent American College of Cardiology annual meeting.
The data were presented by Dr. Jozef Bartunek, associate director of the Cardiovascular Center in Aalst, Belgium and co-principal investigator of the C-Cure trial.
The trial demonstrates that heart failure patients improved heart function and exercise capacity at six months following treatment with C-Cure, a stem cell therapy based on the company’s “cardiopoiesis” technology.
The cardiopoiesis platform is based on fundamental research conducted at Mayo Clinic and is designed to drive the differentiation of adult bone marrow-derived stem cells into cardiac progenitor cells that have the potential to promote heart regeneration when re-injected into the heart of patients suffering from ischemic heart failure.
Forty-five patients with heart failure secondary to ischemic heart disease were recruited in Belgium and Serbia, and randomized to optimal medical care or optimal medical care plus C-Cure treatment.
Demographic and clinical baseline data were similar between 24 controls and 21 patients treated with C-Cure.
The study showed that delivery of C-Cure is feasible without peri-procedural complications. No evidence of cell-induced systemic toxicity or pro-arrhythmogenicity was observed.
Cardiac structural and functional parameters, assessed by echocardiography at six months versus baseline showed the benefit of C-Cure treatment.
– On average, left ventricular ejection fraction (LVEF) was significantly augmented over baseline in the C-Cure versus control cohort (5.2 plus or minus 0.6 percent versus 1 plus or minus 0.7 percent, p!!!!0.01), translating into a 18.1 plus or minus 2.3 percent relative increase in systolic function afforded by cell therapy.
– Reduction of end-systolic volume was 3-times larger in the C-Cure group compared to the control group (from 171 plus or minus 9 to 150 plus or minus 9mL, and from 167 plus or minus 8 to 159 plus or minus 8mL, p=0.01, respectively).
– In contrast to the control cohort, which displayed inter-individual variance, C-Cure treatment invariably led to a pattern of improved left ventricular function in all individuals at 6 months follow-up.
The beneficial effects on cardiac structure and function in the C-Cure group translated into meaningful improved fitness.
The 6-min walk test, an index of overall performance, increased from 396 plus or minus 26 at baseline to 449 plus or minus 35 m at six months in C-Cure (+52 plus or minus 19 m) patients while it decreased from 412 plus or minus 19 to 391 plus or minus 25 m (-21 plus or minus 14 m) in the control group between the same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care.
“Data presented today strongly suggest that C-Cure is a promising treatment for heart failure, one of the world’s greatest unmet medical needs,” Bartunek said. “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.”
Heart failure affects 117 million people and cannot be cured today as current therapies only reduce the severity of disease symptoms.
“Regenerative therapies, such as C-Cure, may offer new hope to patients who currently have limited choices and potentially avoid the need for heart transplantation,” said CEO Dr. Christian Homsy. “The positive outcome of this study reiterates our belief that C-Cure can make a real difference to patients suffering from heart failure. Indeed, we are currently planning the next stages of C-Cure development and are committed to taking the steps needed to successfully bring this new and important treatment to patients. With C-Cure, we aim to become the first company with an approved regenerative product for ischemic heart failure.”
C-Cure is based on a comprehensive strategy developed by Cardio3 BioSciences and leveraging technology licensed from Mayo Clinic. The C-Cure development program is designed to direct the patient’s own stem cells into new heart cells with the potential to rebuild the heart.