Cardio3 BioSciences is the most advanced company in the treatment of heart failure using regenerative therapies designed for the treatment of cardiac diseases, in particular heart failure (HF) and heart attack (AMI). Founded in 2007 based on research conducted since the early 2000s, Cardio3 BioSciences aims at bringing to physicians and patients worldwide, the first effective regenerative medicine for the treatment of heart failure.
While current therapies address the symptoms rather than the root cause of heart failure, Cardio3 BioSciences intends to literally “repair” the heart trough the use of reprogrammed reparative cells. The Company’s product candidates and research programmes are based on an advanced and exclusive cell re-programming technology, called the Cardiopoiesis technology platform. This technology originated from fundamental research conducted at Mayo Clinic (Rochester, Minnesota, USA). It is using the patient’s own bone marrow derived cells and reprogramming them to become cardio-reparative cells that will re-engage the heart self repair mechanisms.
Christian Homsy, CEO, explains: “To date, this technology is the first and currently only cell programming technology to have undergone conclusive human clinical trials for the treatment of heart failure with regenerative medicine: in the previous Phase II trial, C-Cure® showed a 20% improvement in the “Six Minute Walk Test” for treated patients versus the control group, which literally means that treated patients could walk for a longer period of time without feeling out of breath. This is a significant improvement for these patients as the majority of them are no longer able to walk from their bed to the bathroom.” Similar improvements were also seen in heart function and heart structure.
Cardio3 BioSciences’ product candidate C-Cure® is currently in Phase III trial in Europe (CHART-1) and will shortly also start a Phase III trial in the U.S. (CHART-2). During the course of next year, a CHART-3 clinical trial in China should also start, through the Asian Joint Venture that Cardio3 BioSciences and its investor Medisun International agreed to create, providing the company with a strong platform to become the first global player in the field of cardiac regenerative medicines. Christian Homsy, CEO: “With C-Cure®, Cardio3 BioSciences aims to become the first company with an approved regenerative product for ischemic HF and to commercialize a leading edge cell therapy to patients all across the globe.”
Heart Failure (HF): a frequent disease, a severe prognosis
Cardiovascular diseases are the largest cause of mortality in the world, before cancer and infectious diseases. World Health Organization statistics for 2012 show that close to one in three deaths (29%) in the world is due to cardiovascular diseases, representing more than 17 million lives per year.
On heart failure specifically, it is estimated that out of a world population of 5.2 billion people, currently 117 million people are suffering from heart failure, and that this number is believed to double over the next ten years as the incidence is rising for a variety of reasons including lifestyle factors and the increasing life expectancy of patients. In Europe alone, 3.6 million people are diagnosed annually with HF and out of those patients diagnosed, one in three will die within a year of diagnosis (S Neubauer, N Engl J Med, 2007).
HF is a common disease as it is a natural evolution of most cardiac diseases. It is a serious condition in which the damaged heart is unable to pump blood well enough to meet the body’s metabolic needs.
As blood flowing out of the heart and through the arteries slows down, blood flowing into the heart through the veins backs up and causes fluid to build up in the lungs, leading to shortness of breath and fatigue, and in the legs, causing swelling of the legs. HF patients vary in their symptoms from very mild, through shortness of breath during moderate exercise to severe where daily life activities are impaired. In the most severe stages, patients are exhausted even at rest.
Today, heart failure cannot be cured or repaired, and most of the current therapies only reduce the severity of symptoms: they aim at relieving suffering, reducing the work that the heart has to do to eject the blood, or increasing the contractile efficiency of the remaining muscle. While these therapies have greatly improved the prognosis of patients suffering from heart failure, none are addressing the root cause, which is the lost of contractile tissue. As such, regenerative therapies, like C-Cure®, could offer new hope to these patients.
Stem Cell therapy and cardiac diseases: new hope to patients
Most organs (such as the skin and bone) have a certain capacity for self-repair due to the presence of special stem cells in the body. The heart does not have this capacity: it does not harbor large quantities of cardiac stem cells and therefore, cannot rely on a natural self-repair capacity for damages that other organs to a certain extent have. The challenge is therefore to provide the injured heart with cells that have the capacity to trigger this self repair mechanism. Fundamental research at Mayo Clinic uncovered the mechanisms in the embryo that make an embryonic stem cell become a heart cell. This led to the identification of a set of growth factors signaling the transformation of adult stem cells into cardio-reparative cells. This technology is the exclusive property of Cardio3 BioSciences.
An exclusive cell reprogramming technology to regenerate the heart muscle
The Cardiopoiesis technology platform is designed to drive the differentiation of adult stem cells into new cardiac progenitor cells. This exclusive technology is the first and currently only stem cell programming technology to have undergone conclusive human clinical trials for the treatment of heart failure with regenerative therapies. The goal of these therapies is to protect the heart in the event of myocardial attack, reduce scar volume of the scar and rebuild damaged heart tissue. C-Cure® cell therapy is constituted from stem cells from the heart-failure patient, which transform themselves as part of a patented procedure into “cardiopoietic cells” (cardio-healing cells) able to regenerate damaged heart muscle without risk of rejection.
C-Cathez ez ® – a proprietary injection catheter
Cardio3 BioSciences also developed C-Cathez®, an injection catheter, which provides the company with the ability to also control the delivering system that will bring the cell therapy to the patient’s heart. C-Cathez® is designed to optimize the delivery and improve the retention of stem cells into the myocardium, reducing the risk of perforation, increasing needle stability and delivering enhanced fluid dynamics to improve retention. C-Cure® and C-Cathez® represent Cardio3 BioSciences’ most advanced technologies in the treatment of heart failure of ischemic origin.
Next to C-Cure® and C-Cathez®, Cardio3 BioSciences also develops non-cell protein programs, particularly for the treatment of myocardial infarction and is also active in several other R&D programs. Christian Homsy, CEO, further expands: “Regenerative medicine is only in its early stage and we will undoubtedly build on the expertise we have developed in the cardiac area and the cell biology technologies to pursue our research in organ regeneration by, for example, extending it to other organs, or any cellular related diseases such as cancer.”