Posted by Michael Wonder on 17 Dec 2017
US FDA grants fast track designation to Renova Therapeutics’ RT-100 AC6 gene transfer for the treatment of heart failure
14 December 2107 - FLOURISH Phase 3 clinical trial in patients with heart failure and reduced ejection fraction to begin in Q1 2018.
Renova Therapeutics announced today that the U.S. FDA has granted fast track designation for the company’s lead product candidate, RT-100 AC6 gene transfer (Ad5.hAC6), for the treatment of heart failure with reduced ejection fraction.
Renova Therapeutics will conduct a randomised, placebo-controlled, double-blind multicenter Phase 3 trial of intra-coronary delivery of RT-100 to evaluate safety and efficacy. This pivotal trial – known as FLOURISH (Heart Failure with Reduced Left Ventricular Ejection Fraction: One-time Gene Transfer Using RT-100 – Intracoronary Administration of Adenovirus 5 encoding Human AC6) – is expected to commence in Q1 2018 in the United States.
