Cardios biosciences allowed to enroll patients in phase 3 clinical trial.
MONT-SAINT-GUIBERT, Belgium, October 13, 2014--Cardio3 BioScicnccs (C3BS) (EURONEXT: CARD has received authorization from Swissmedic, the Swiss agency for the authorization and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase 3 trial for C-Cure in Switzerland.
Switzerland is the 12th country to have authorized this study, which aims to treat ischemic congestive heart failure. Other countries include Bulgaria, Sweden, Ireland, the United Kingdom, Belgium, Israel, Serbia, Hungary, Spain, Italy, and Poland.
The CHART-1 trial (Congestive Heart failure Cardiopoietic Regenerative Therapy) represents the world's first Phase 3 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 Bio-Sciences is expected to finalize the recruitment of the last patients towards end of 2014. In parallel, CHART-2, the FDA-approved Phase 3 clinical trial, will also start around the end of the year.
The Phase 3 trial is a prospective, multicenter, 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.
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|Title Annotation:||In The Clinic|
|Publication:||Stem Cell Lab World|
|Date:||Oct 20, 2014|
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