Cardio3 BioSciences Receives Authorization to Enroll Patients in Sweden in its Phase III Clinical Trial CHART-1

Cardio3 BioSciences Receives Authorization to Enroll Patients in Sweden in its Phase III Clinical Trial CHART-1

 

  • 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 (LÄ KEMEDELSVERKET) 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.