Belgian biotechnology firm Cardio3 BioSciences has secured approval from the Italian Medicines Agency (Agenzia Italiana del Farmaco) to start its congestive heart failure cardiopoietic regenerative therapy (CHART-1) European Phase III trial for its lead product candidate C-Cure in Italy.
The prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded Phase III trial has been designed to evaluate the effectiveness of C-Cure, compared to a sham treatment.
Around 240 patients with chronic advanced symptomatic heart failure will be enrolled in the CHART-1 trial, which will be carried out at six clinical centers in Italy.
Composite endpoint such as mortality, morbidity, quality of life, six minute walk test and left ventricular structure and function at nine months post-procedure are the primary endpoints of the trial.
The CHART-1 trial is claimed to be the first Phase III trial for a pre-programmed cellular therapy targeting heart failure.
Cardio3 BioSciences CEO Christian Homsy said, "Adding another big European country like Italy, which will open six sites, will enable us to pursue the study according to our development plan."
In addition to Italy, the trial has already been authorized in Spain, the UK, Belgium, Israel, Serbia and Hungary.