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Juventas Therapeutics completes enrollment of Phase II STOP-HF study of JVS-100 in patients with symptomatic heart failure
Date:10/28/2013

CLEVELAND, Oct. 28, 2013 /PRNewswire-USNewswire/ -- Juventas Therapeutics, a privately-held clinical-stage company developing novel therapies for treatment of cardiovascular disease, announced today that the company has completed enrollment of the STOP-HF trial. STOP-HF is a double-blinded, placebo-controlled, multi-center trial of its non-viral DNA plasmid therapy JVS-100 for patients with symptomatic heart failure. A total of 93 patients have been enrolled in this trial at 16 academic and community hospitals throughout the United States.

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Patients enrolled in STOP-HF had a prior history of a heart attack and years later developed symptomatic heart failure as defined by an ejection fraction less than 40 percent and poor quality of life and exercise tolerance as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHQ) and six minute walk distance (6MWD), respectively. Patients were randomized to placebo or treatment with two different doses of JVS-100.  Therapy was directly delivered to the heart via endo-ventricular injection using the BioCardia Helical Infusion CatheterTM.  In addition to safety, data for several efficacy endpoints is being collected at four months and one-year post-treatment including heart failure related hospitalizations, major adverse cardiac events, and changes in 6MWD, MLWHQ scores, and ejection fraction.

"The patients studied in this trial, on average, have experienced their most recent heart attack nearly a decade prior to treatment and their heart failure symptoms have progressed to a point that their health and ability to perform the activities of daily living are significantly deteriorating despite receiving optimal medical management," states Marc Penn M.D.,
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SOURCE Juventas Therapeutics
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