Cardio3 BioSciences (C3BS) has announced the advanced publication of C-CURE (Phase II) trial results in the on-line edition of the Journal of the American College of Cardiology (JACC).
The publication reported:
• Statistically significant improvement in cardiac function for the treated patients
• Statistically significant improvement in 6-minute walk distance for the treated patients
The publication concluded that the therapy with C3BS-CQR-1 (previously C-Cure) was feasible and safe with signals of benefit in chronic heart failure, meriting further definitive clinical evaluation.
The C-Cure trial was a prospective, multicenter, randomized study to evaluate the feasibility, safety, and efficacy of CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.
CQR-1 consists of the patient’s own stem cells harvested from the bone marrow and engineered to become progenitors of new functional cardiac cells. Those cells behave identically to the cells lost to heart disease.
In the C-Cure trial, all patients received optimal standard-of-care for heart failure, while treated group also received an intra-myocardial injection of CQR-1.
On the basis of these outcomes, C3BS has initiated a Phase III trial for CQR-1, called CHART-1 for Congestive Heart failure Cardiopoietic Regenerative Therapy.
This is the first Phase III trial using organ specified cells for the treatment of ischemic heart failure and will recruit approximately 240 patients, with chronic advanced symptomatic heart failure underlining Cardio3 BioSciences’ dedication and leadership in bringing regenerative therapies to patients.
The primary endpoint of the trial integrates cardiac and clinical endpoints as recommended by the European Medicines Agency.
Dr Jozef Bartunek, Principal Investigator, said: “The Phase II trial demonstrates that cardiopoietic stem cell therapy is feasible, safe and with strong signals of efficacy. These results highlight the promise of such novel technology for optimized regenerative intervention in heart failure, bringing next generation therapies to patients. With Cardio3 BioSciences having started the follow-up Phase III trial, the cardiopoietic approach is at the forefront of this exciting field.”
Dr Christian Homsy, CEO of Cardio3 BioSciences, added: “Publication of the C-Cure trial results in a journal as prestigious as JACC highlights the quality of the science underlying our lead product, CQR-1. We look forward to confirming the promising Phase II results, in our Phase III trial. Worldwide, this is the first pivotal Phase III study assessing such advanced regenerative product for the treatment of heart failure. We believe that the innovative science behind our product has the potential to revolutionize the treatment of this debilitating disease.”
Prof. Dr. André Terzic, lead regenerative medicine specialist at Mayo Clinic in Rochester (MN), USA and Co-Principal Investigator of the C-Cure Clinical Trial, commented: “Heart failure is a major global challenge with the aging of the population and the shortage of donor organs. By introducing lineage guidance into the cell therapy protocol, the C-CURE trial provides initial clinical evidence for a new approach in cardiovascular regenerative medicine. Clinical translation of cardiopoietic stem cell therapy indicates favorable impact on myocardial remodeling, left ventricular ejection fraction, and global wellness. The C-CURE trial thus advances the paradigm of stem cell therapy, providing a rationale for further clinical validation.”