Juventas Therapeutics to Present Top-Line Interim Results from Phase II STOP-HF Trial in Late-Breaking Oral Presentation at European Society of Cardiology Heart Failure Congress
CLEVELAND, May 6, 2014 /PRNewswire-USNewswire/ -- Juventas Therapeutics today announced that top-line interim data from its ongoing Phase II STOP-HF study will be presented in a late-breaking oral presentation at the European Society of Cardiology Heart Failure Congress (ESC-HF) taking place May 17 – 20, 2014 in Athens, Greece. The STOP-HF trial is a randomized, placebo-controlled, doubleblinded study conducted at 15 centers in the United States to evaluate safety and efficacy of JVS-100 in patients with symptomatic ischemic cardiomyopathy. Co-Principal Investigators for the trial are Drs. Warren Sherman, Director of Stem Cell and Regenerative Medicine, Cardiovascular Research Foundation, Columbia University Medical Center, Leslie Miller, Pepin Heart Institute, and Eugene Chung, Director of Heart Failure, the Ohio Heart and Vascular Center.
The STOP-HF study was designed to evaluate safety and efficacy of JVS-100 in patients with systolic heart failure of ischemic etiology. Ninety-three patients were enrolled under the inclusion criteria of having an ejection fraction ≤40%, six-minute walk distance (6MWD) ≤400 meters and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score ≥20 points. Upon enrollment, patients were randomized to receive one of two JVS-100 doses or placebo. The study drug was administered directly to the heart via the BioCardia Helical Infusion Catheter (HIC).
"The patients studied in STOP-HF comprise a population that are already on optimal medical therapy and whose heart failure is rapidly progressing," states Marc Penn, M.D., Ph.D., Founder and Chief Medical Officer for Juventas Therapeutics and Director of Cardiovascular Research at Summa Health System. "JVS-100 has been shown in multiple pre-clinical and Phase I studies to slow or reverse disease progression. We look forward to sharing our findings from this most recent Phase II study."
JVS-100 is a non-viral DNA plasmid that expresses human Stromal cell-Derived Factor 1 (SDF-1). SDF-1 has been shown by several independent laboratories to improve cardiac function following a heart attack through recruiting endogenous stem cells to the damaged region, promoting new blood vessel growth and preventing ongoing-cell death. In a Phase I study, Juventas previously demonstrated safety and preliminary clinical benefit for JVS-100 in patients with NYHA Class III heart failure.
Dr. Penn will present the STOP-HF four-month safety and efficacy results as a late-breaking clinical trial at ESC-HF on May 19, 2014.
"We are excited by the results from STOP-HF, which demonstrate for the first time in a randomized, double-blinded, placebo controlled trial that JVS-100 has therapeutic potential for patients with advanced heart failure," states Rahul Aras, Ph.D., President and CEO for Juventas Therapeutics. "It is an honor to share these findings at a prominent international conference such as ESC-HF. We look forward to advancing our clinical study of this novel therapy."
About Juventas Therapeutics
Juventas Therapeutics, headquartered in Cleveland, Ohio, is a privately held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat life–threatening diseases. Founded in 2007 with an exclusive license from Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to through mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include Triathlon Medical Venture Partners, New Science Ventures, Fletcher Spaght Ventures, Tak eda Ventures, Venture Investors, Early Stage Partners, Reservoir Venture Partners, and Cleveland Clinic. The company has also received financial support through the Ohio Third Frontier-funded Global Cardiovascular Innovation Center, Center for Stem Cell & Regenerative Medicine and the National Center for Regenerative Medicine.