Cardiology

Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today it has received authorization from Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Switzerland.

After the recent authorization in Bulgaria, and earlier in Sweden, Ireland, the United Kingdom, Belgium, Israel, Serbia, Hungary, Spain, Italy, and Poland, Switzerland is the 12th country to have authorized this unique study, which aims to treat ischemic congestive heart failure.

The CHART-1 trial (Congestive Heart failure Cardiopoietic Regenerative Therapy) represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure. Earlier this year, the Company received approval from the DSMB (Data Safety and Monitoring Board) to continue CHART-1 without any changes to the original protocol. The members of the DSMB analyzed safety data 1-month post treatment and unanimously concluded that C-Cure® and C-Cathez® show no safety issue. Now in the final stages of this clinical trial, and with recruitment continuing to be strong, Cardio3 BioSciences is expected to finalize the recruitment of the last patients towards end of 2014. In parallel, CHART-2, the FDA-approved Phase III clinical trial, will also start around the end of the year.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are approaching the final recruitment phase of our Phase III clinical study for C-Cure® and remain on schedule to finalize recruitment towards end of 2014. The addition of Switzerland in our clinical study is a very positive sign. It is yet another demonstration that ischemic heart failure is an indication for which there is an urgent need for a truly curative therapy. Our hope that C-Cure® will become that therapy is growing every day.”

The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure.

Mont-Saint-Guibert, Belgium, – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of advanced regenerative therapies for heart disease, announces today that it has enrolled the 120th patient in its phase III clinical study CHART-1, aimed at evaluating the potential of its product candidate C-Cure® for the treatment of heart failure. This represents the half of patients to be recruited into CHART-1.

With over 25 active centers in 10 countries, the Company is in line with its goal of completing the recruitment of all patients by the end of 2014.

CHART-1 is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure. This study represents the world’s first Phase III trial for a pre-programmed cellular therapy targeting heart failure.

To date, no incidents reported in the study call into question the continuation thereof. The safety analysis during the third quarter and futility analysis around the end of this year are the next steps in the study.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: “We are very pleased to announce the recruitment of the 120th patient that keeps us on target with our goal of enrolment. This is an important milestone that demonstrates the momentum seen into the start of 2014. Everyday, thanks to the commitment of our teams and clinical centers that combine enthusiasm and competence, we are coming closer to our goal which is to bring a totally new and different treatment to thousands of patients suffering from heart failure.”

• CHART-1 trial represents the world’s first Phase III trial in regenerative medicine for a pre-programmed cellular therapy targeting heart failure
• To date, ten countries have granted authorization for Cardio3 BioSciences’ Phase III (CHART-1)

Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (Euronext Brussels and Euronext Paris : CARD), leader in the discovery and development of advanced regenerative therapies for heart disease, today announces it has received authorization from the Swedish Medical Products Agency (LÄKEMEDELSVERKET) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Sweden. 

After the recent authorization in Ireland, and earlier in United Kingdom, Belgium, Israel, Serbia, Hungary, Spain, Italy, Poland and Ireland, Sweden is the tenth country to have authorized this unique study, which aims to treat ischemic congestive heart failure. 

The CHART-1 trial (Congestive Heart failure Cardiopoietic Regenerative Therapy) represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased with the progress of our Phase III clinical study. Adding another European country will enable us to pursue the CHART-1 study according to our objectives.”

The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure. 

• CHART-1 trial represents the world’s first Phase III trial in regenerative medicine for a pre-programmed cellular therapy targeting heart failure
• To date, nine countries have granted authorization for Cardio3 BioSciences’ Phase III (CHART-1)

Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (NYSE Euronext Brussels et NYSE Euronext Paris : CARD), leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces it has received authorization from the Irish Medicines Board (IMB) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Ireland. 

After the recent authorization in Poland, and earlier in United Kingdom, Belgium, Israel, Serbia, Hungary, Spain and Italy, Ireland is the ninth country to have authorized this unique study, which aims to treat ischemic congestive heart failure. 

The CHART-1 trial (Congestive Heart failure Cardiopoietic Regenerative Therapy) represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased with the progress of our Phase III clinical study. Adding another European country will enable us to pursue the CHART-1 study according to our objectives.”

The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure. 

Editorial highlights next generation stem cell solutions optimized for heart failure therapy 

Mont-Saint-Guibert, Belgium, – Cardio3 BioSciences (C3BS) (NYSE Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, announces today the referencing in the European Heart Journal, the official journal of the European Society of Cardiology, of lineage-specified cardioreparative stem cells as next generation regenerative biotherapeutics.

The editorial sets out the principles of regenerative cardiology, conceived to halt or reverse disease progression. As the heart has a limited self-renewal capacity, stem cell therapies are applied essentially as adjuvants to standard of care with the goal of fortifying reparative mechanisms. The editorial emphasizes that the inter-trial unevenness and inter-patient variability observed to date with conventional stem cell options has prompted the pursuit of optimization strategies, and lists optimization modalities under consideration, such as the principle to condition the myocardial environment prior to cell delivery, the principle to match regenerative cell source with the target organ, and the principle of rational design of cardioreparative biotherapeutics equipped with an upgraded regenerative potential.

The Cardio3 Biosciences’ C-Cure® product is the first-in-class cardioreparative biotherapeutics derived by the method of lineage-specification for use in heart failure. In the Phase II C-CURE clinical trial, heart failure patients were treated with C-Cure® which consists of patient-derived mesenchymal stem cells oriented into lineage-specified cardiogenic progenitor (cardiopoietic) cells. The C-CURE study indicates that the use of cardiopoietic cells is feasible and safe and documents significant benefit on Left Ventricular Ejection Fraction, a measure of heart function, versus baseline compared to no change for the control group treated with standard of care. C-Cure® is now tested in a Phase III study in Europe and Israel (CHART-1) and has been authorized by the FDA to be tested in the U.S (CHART-2). These phase III therapeutic studies highlight advances in regenerative science.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: “Recognition in this editorial published in the prestigious European Heart Journal underscores Cardio3 BioSciences’ continuous advances and leadership in regenerative medicine, progressively bringing innovative science-driven therapeutic options to patients. By choosing the route of lineage specification, we lay the foundation for future standard of care in cardiology.”

Review highlights C-Cure as a next advance in regenerative science

Mont-Saint-Guibert, Belgium, – Cardio3 BioSciences (C3BS) (NYSE Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces the referencing in the journal Nature Reviews Cardiology of lineage-specified cardiac progenitor (Cardiopoietic) cells as a next generation advancement in the science of cardiac regeneration.

The review retrospectively evaluates and correlates the different approaches employed in cardiac regeneration over the past decade and underscores the recent advances in the purification and lineage specification of stem cells.

The review points to the safety and feasibility of cell-based therapy as worldwide, thousands of patients to date have been treated using autologous approaches. The authors state that the main factors limiting adoption of cell therapies comprise the poor definition of cell types used, diversity in cell handling procedures and functional variability intrinsic to autologouslyderived cells.

The outcomes of the various trials analyzed in the review suggest that cardiac-progenitors confer therapeutic benefit. Cardiac progenitors could be either derived from the heart or be cardiac lineage–specified, the latter a method used to generate C-Cure. Cardiac lineagespecified cells are guided ex vivo to differentiate into cardioreparative cells.

In the C-Cure trial, heart failure patients were treated with C-Cure® which consists of cardiac progenitor (cardiopoietic) cells. The findings of the study indicate that the use of cardiac progenitor cells (CP-hMSC) is feasible and safe and documents a statistically significant improvement of Left Ventricular Ejection Fraction, a measure of heart function, versus baseline compared to no change for the control group who were treated with standard of care. Based on these results, C-Cure® is being tested in a Phase III study in Europe and Israel (CHART-1) and has been authorized by the FDA to be tested in the U.S (CHART-2). These phase III therapeutic studies highlight advances in regenerative science.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: “Being recognized in this review published in Nature Reviews Cardiology highlights Cardio3 BioSciences’ technology and leadership in bringing new therapeutic options to patients. By choosing the route of lineage specification, we once again demonstrate that we are at the forefront of the cardiac regenerative medicine industry.”