Products pipeline

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).

Cells

C-Cure®(C3BS-CQR-1)

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.  

See more details on this Press Release.

Further details on Study Summary

Discover more about Phase 3 authorization


Proteins

C3BS-GQR-4

C3BS-GQR-4 is being developed for the treatment of heart damage induced by ischemia reperfusion injury (IRI) consequent to acute myocardial infarction. It has been designed to target the co-stimulatory molecules, which have been shown to play a crucial role in T cell proliferation and activation. With C3BS-GQR-4, Cardio3 Biosciences made the hypothesis that blocking the co-stimulatory pathway at the time of reperfusion was a very promising target for the treatment of IRI consequent to AMI. Taking advantage of the availability of products which are commercially accessible as being developed for different indications such as for cancer treatment, creates fast track perspectives in preparation of its proof-of-concept in GLP preclinical animal model in preparation of its firstin-man clinical evaluation. This proof of concept trial will be performed under GLP conditions as regulatory required. Before initiation a Phase I/II clinical trial, large animal trials will be conducted under GLP conditions to support a first human trial.


Device

C-CATHez®

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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