The DSMB (Data Safety and Monitoring Board), a committee composed of international independent experts, unanimously recommends continuing the study according to the original protocol, after having analyzed safety data relating to C-Cure® and C-Cathez® in the ongoing Phase III clinical trial conducted in Europe and Israel
Mont-Saint-Guibert, Belgium - Cardio3 BioSciences SA (C3BS) (NYSE Euronext Brussels and 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 the recommendation of the Data Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical trial according to the original protocol. The recommendation is based on a planned analysis performed on all patient safety data available as per mid-August 2014.
The Data Safety and Monitoring Board is an independent committee composed of independent international experts in charge of safety evaluation of C-Cure® and C-Cathez® in the CHART-1 Phase III clinical trial currently underway in several countries in Europe and in Israel. The DSMB analyzed safety data 1-month post treatment of all patients randomized in the trial.
The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.
The members of the DSMB approved unanimously the continuation of the trial having concluded that one month post treatment, C-Cure® and C-Cathez® shows no safety issue that compromises the continuation of the CHART-1 Phase III study.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased by the unanimous recommendation of the DSMB to continue to pursue CHART-1. This planned analysis is a significant step in our Phase III program and the positive outcome confirms all the confidence placed in the trial by our partners and investors. CHART-1 continues to progress well and the positive view of the DSMB will add further impetus to recruitment which we look forward to completing on schedule by the end of 2014.”
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 nine months post-procedure.
For more information contact:
Cardio3 BioSciences
Dr Christian Homsy, CEO
Julie Grade, Corporate Communication Manager
www.c3bs.com
Tel : +32 10 39 41 00
Citigate Dewe Rogerson
Chris Gardner
Tel : +44 (0) 207 638 9571
If you want to subscribe to the company newsletter, please fill in the subscription form on the website www.c3bs.com About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium.
The Company’s lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient’s own cells that are harvested from the patient’s bone marrow and engineered to become new heart muscle. This process is known as Cardiopoiesis.
Cardio3 BioSciences has also developed C-Cath®ez, the most technologically advanced injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.
Cardio3 BioSciences’ shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD.
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