Key scientific work in Cardio3 BioSciences' C-Cure stem cell heart failure treatment published in JACC

- Article Described a Landmark Process Generating Cardiac Precursor Cells to Rebuild Heart Tissue

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular disease, today announces that the key scientific work underlying its lead pharmaceutical product C-Cure(R), a revolutionary stem cell treatment for heart failure, has been published in the Journal of the American College of Cardiology (JACC). The findings were described as "landmark work" in the accompanying editorial in today's publication.

The research, carried out at Mayo Clinic in Rochester, Minnesota, USA, and in collaboration with the Cardiovascular Center in Aalst, Belgium led to the development of Cardio3 BioSciences' technological platform designed to reprogram the patient's own stem cells to rebuild the heart.

In this ground-breaking work, researchers were able to identify a process involving a cocktail of growth factors to successfully reprogram mesenchymal (connective tissue) stem cells (MSCs) harvested from the bone marrow of heart failure patients into cardiac precursor cells.

Injected into an animal model of heart disease, these cardiac precursor cells improved heart function by repopulating scar tissue and generating new blood vessels, effectively eliminating the scar and rebuilding the heart with new functional human heart tissue. Treated animals demonstrated improved heart function and were cured from their heart failure.

In their editorial, Eduardo Marban, M.D., Ph.D., and Konstantinos Malliaras, M.D., of Cedars-Sinai Heart Institute, describe the Mayo approach as a "boot camp" for stem cells and that the study "...provides the first convincing evidence that MSCs, at least in vitro, can in fact become functional cardiomyocytes (heart cells)..."

Cardio3 BioSciences has advanced the development of this technology with the recent conclusion of a Phase II clinical trial that recruited 45 heart failure patients in Europe. The Company recently announced that its lead compound C-Cure had an excellent safety profile and observed positive trends in both physiological and clinical heart function, as was anticipated from the animal model data published in JACC. C-Cure's unique repair action on heart muscle is projected to yield clinical benefits in a Phase III trial setting.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: "Publication of this research in a journal as prestigious as JACC highlights the quality of the science underlying our lead product. This trans-Atlantic effort involving leading edge science in both the US and Belgium served to dramatically increase the potency of human stem cells to repair heart tissue and provides the basis for C-Cure, a therapy that could revolutionize the treatment of this devastating disease.

"Based on this world-class science and the insights and confidence we have gained from our first clinical trial, we are now finalising the design of our pivotal clinical program for C-Cure and look forward to continuing to steps needed to bring this much needed treatment to patients."