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.
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., Ph.D., Chief Medical Officer for Juventas and Director of Research, Summa Cardiovascular Institute at Summa Health Systems. "The goal of STOP-HF is to further define the safety and clinical benefits of JVS-100 in heart failure patients who are already receiving the current standard of care."
Earlier this year, Juventas Therapeutics completed enrollment of STOP-CLI, a Phase IIa first-in-human, double-blinded, placebo-controlled, dose-escalation trial of JVS-100 for patients with Rutherford class 4 or 5 critical limb ischemia (CLI). The 48-person trial enrolled CLI patients considered poor candidates for revascularization at four centers in the United States and two centers in India. The primary endpoint for the trial will be safety with efficacy data collected on several key endpoints including amputation rates, Rutherford class, wound closure, and pain management.
"Completing enrollment of STOP-CLI and STOP-HF are significant milestones for the company this year," states Rahul Aras, Ph.D., President and CEO for Juventas Therapeutics. "To date, more than 120 patients have received JVS-100 therapy and we are building a strong safety profile. Next year is an important year for Juventas, with efficacy data results targeted from both Phase II studies and additional trials scheduled to enroll. We are excited to transition JVS-100 into late stage clinical trials and commercialization."
About Juventas Therapeutics
Juventas Therapeutics, headquartered in Cleveland, Ohio, is a privately-held clinical-stage biotechnology company developing therapies for cardiovascular disease. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Triathlon Medical Venture Partners, Takeda Ventures, Early Stage Partners, Fletcher Spaght Ventures, Venture Investors, Reservoir Venture Partners, The Cleveland Clinic, Glengary, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received support through the Ohio Third Frontier funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center, and Center for Stem Cell and Regenerative Medicine.
The company's lead product, JVS-100 encodes Stromal–cell Derived Factor 1 (SDF–1). JVS-100 is a non-viral DNA plasmid that has been shown to protect and repair tissue following organ–injury in a broad range of pre–clinical disease models. The first clinical targets will be treatment of patients with advanced symptomatic heart failure and critical limb ischemia. The company has demonstrated in pre-clinical models that JVS-100 therapy has the potential to repair tissue-damage following ischemic injury by recruiting the body's own stem cells to the damaged region, the prevention of cardiac cell death, and promotion of new blood vessel growth in the heart. In addition to heart failure, Juventas is also developing JVS-100 for additional indications including acute myocardial infarction, chronic angina, and muscle regeneration.