- To date, six countries have granted authorization for Cardio3 BioSciences’ Phase III (CHART-1)
- CHART-1 trial represents the world’s first Phase III trial for a preprogrammed cellular therapy targeting heart failure
Mont-Saint-Guibert, Belgium - The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a 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 Spanish Agency for Medicines and Health Products (AEMPS) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Spain.
Spain is the sixth country to have authorized this unique study after the United Kingdom, Belgium, Israel, Serbia and Hungary.
To date, 11 internationally-renowned centers have begun recruiting patients in those countries. First patients were treated in June 2013.
The CHART-1 trial represents the world’s first Phase III trial for a pre-programmed cellular therapy targeting heart failure.
Professor Francesco Aviles, the Principal Investigator in Spain commented: “This approval allows Spanish medical institutions to start enrolling patients in the CHART-1 trial and join the group of other distinguished investigators that are already active in the trial. Six clinical centers are ready to start. We are proud to participate in this Phase III trial evaluating the benefit of C-Cure cardiopoietic cells for the treatment of severe heart failure. The Phase II data published in JACC earlier this year provide a strong scientific rationale for this technology and the potential it has to change the standard of care for our patients."
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “The authorization by the Spanish authorities is another important step in our development plan. We believe our unique therapy offers the potential to revolutionize treatment for heart failure, a common and severe illness."
The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C3BS-CQR-1 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.
Studies in additional countries will commence once national regulatory approvals have been received.