Mont-Saint-Guibert, Belgium, June 4th, 2013 –The biotechnology company, Cardio3 BioSciences SA (Cardio3 BioSciences), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, announces it is considering to raise new funds through an Initial Public Offering on NYSE Euronext Brussels and NYSE Euronext Paris.
Cardio3 BioSciences’ lead product is C-Cure®, a unique therapy that involves taking cells from a patient’s bone marrow. Through a proprietary process called cardiopoiesis, the cells are reprogrammed so that they become heart precursor cells with the aim of replicating the normal process of cardiac development in the embryo and healing the failing heart. The cells, known as cardiopoietic cells, are then injected back into the patient’s heart through a minimally invasive procedure using a proprietary catheter called C-Cathez ® , with the goal of repairing damaged tissue and improving heart function, clinical outcomes and quality of life.
Cardio3 BioSciences is developing C-Cure® for the treatment of heart failure, one of the world’s greatest unmet medical needs. A person living to age 40 years has a one in five risk of developing heart failure and, once the disorder is apparent, a one in three chance of dying within a year of diagnosis (McMurray and Pfeffer 2005 – see below). US$32 billion per annum is spent on heart failure patients in the US alone (Go et al. 2013 – see below).
C-Cure® builds on research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences and Cardiovascular Centre Aalst (Aalst, Belgium). The product is currently being tested in Europe in a Phase III trial (CHART-1 – Congestive Heart failure Cardiopoietic Regenerative Therapy). CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells for the treatment of heart failure.
The CHART-1 study builds on the successful results of Cardio3 BioSciences’ Phase II trial of C-Cure, which were recently published in the Journal of the American College of Cardiology (JACC) (Bartunek et al. 2013 – see below). The study showed an increase of 25% of the Left Ventricular Ejection Fraction (LVEF) which was statistically significant (p
Cardio3 BioSciences intends to start a trial in the USA (the CHART-2 trial) when and if the FDA authorizes its start. The CHART programme is designed as two pivotal studies to obtain marketing authorisation in Europe and in the USA respectively, either alone, or in combination with other clinical trials.
In addition to C-Cure®, Cardio3 BioSciences has developed a proprietary technology aimed at maximising the delivery efficiency of therapeutics into the heart muscle. C-Cathez ® is an intramyocardial delivery catheter, designed to enhance myocardial therapeutic agents’ retention. The Company has obtained CE marking in April 2012 from NSAI (an Irish Notified Body).
Cardio3 BioSciences also has early stage programs in progress aimed at using protein therapeutics to treat acute myocardial infarction (AMI) or “heart attack”. The IPO is expected to consist of an offering of new shares which will be listed on NYSE Euronext Brussels and NYSE Euronext Paris. Kempen & Co has been appointed as Sole Global Coordinator and Kempen & Co and Invest Securities have been appointed as Joint Bookrunners.