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Cardio3 Biosciences SA receives IND clearance from the FDA for CHART-2 Phase III heart failure clinical trial


Thursday, 9 Jan 2014 09:00am EST 

Cardio3 Biosciences SA:Says that the U.S. Food and Drug Administration (FDA) has authorized the company's Investigational New Drug (IND) application for clinical testing of the company's regenerative medicine product C3BS-CQR-1 (C-Cure) as a treatment targeting heart failure.Says CHART-2, the company's second Phase III clinical trial, is intended to assess in the US, the efficacy of C3BS-CQR-1 as a treatment for heart failure of ischemic origin.Says CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded study comparing treatment with C3BS-CQR-1 to a sham treatment.Says the trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.Says primary endpoint of the trial is the Six Minute Walk Test post-procedure, a commonly used index of cardiovascular performance.