Cardio3 BioSciences is developing the breakthrough proprietary Cardiopoiesis platform, which is based on fundamental research and proprietary technology from Mayo Clinic. This novel platform is designed to drive the differentiation of multipotent stem cells into new cardiac progenitor cells. Based on this Cardiopoiesis platform, the Company has generated a pipeline of product candidates and research programmes targeting heart failure (HF) and acute myocardial infarction (AMI).
C-Cure® is Cardio3 BioSciences' most advanced product candidate based on the Cardiopoiesis platform. C-Cure® is being developed for HF indications and consists of a patient's own cells harvested from bone marrow, treated with the Cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells which behave identically to those lost in infarction without carrying the risk of rejection.
Modes of Action
C-Cure has two modes of action:
- directly through the proliferation, engrafment and terminal differentiation of the injected cells; and
- indirectly through the beneficial effect of the factors excreted by the transplanted cells on the host's own resident cardiac stem cells.
Positive Phase II results
In the Phase II clinical trial (the C-Cure® trial), heart failure patients treated with C-Cure® showed a highly significant 25% relative improvement of Left Ventricular Ejection Fraction (a measure of heart function) versus baseline compared to a relative improvement of 3.6% versus baseline for the control group who were treated with standard of care alone. Certain other measures of improvement such as the ventricular volumes or measures of ventricular remodelling were also in favour of the C-Cure group. In addition, patients in the C-Cure group had a statistically significantly better exercise capacity as measured by a standard test called the "six minute walking distance test": the C-Cure group's walking distance improved over the control group by 77 meters. On the basis of these positive results, Cardio3 BioSciences filed in spring 2012 for regulatory authorization to carry out a Phase III clinical program. Approval to start the trial in Belgium and UK was obtained in November 2012. With C-Cure, Cardio3 BioSciences aims to become the first company with an approved regenerative product for ischemic HF.
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Further details on Study Summary
Discover more about Phase 3 authorization
Drawing on its understanding of the processes involved in Cardiopoiesis, Cardio3 BioSciences has formulated C3BS-GQR-1, a protein-based product candidate which is aimed at protecting heart tissue from acute injury and promoting activation of resident cardiac stem cells in an AMI setting. A pre-clinical proof-of-concept study in swine showed a 65% decrease in scar size at six weeks post infarction compared to a 25% decrease in scar size following a placebo injection. Cardio3 BioSciences intends to further develop C3BS-GQR-1, including encapsulating the factors in matrices to achieve sustained release over the desired two-week period. The intention of the Company is to seek to partner this programme once the programme is sufficiently advanced.
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Cardio3 BioSciences has developed a proprietary technology aimed at maximizing the delivery efficiency of regenerative therapeutics to the heart. C-Cathez is an intra-myocardial delivery catheter, designed to reduce risk of myocardium perforation, increase needle stability and deliver enhanced fluid dynamics to improve retention. Efforts to set up a quality management system that is conform to ISO 13485:2003 are completed. Final design, that addressed the most recent comments received from key opinion leaders in terms of the ease of handling of the device, is also completed. C-Cathez obtained CE mark in April 2012 and is therefore available for clinical use worldwide and commercial use outside of the U.S.
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