Juventas Therapeutics Presents New 12-Month Data Demonstrating Single Administration of JVS-100 Improves Cardiac and Clinical Status in Patients with Severe Ischemic Heart Failure One Year After Treatment
-Final 12-Month Results from Phase 2 STOP-HF Trial Presented in a Late-Breaker at European Society of Cardiology - Heart Failure 2015 and Published in European Heart Journal-
CLEVELAND and SEVILLE, Spain, May 26, 2015 /PRNewswire/ -- Juventas Therapeutics, Inc., a clinical-stage biotechnology company focused on developing non-viral gene therapies to treat advanced cardiovascular diseases, today presented new 12-month data demonstrating that a single administration of Juventas' non-viral DNA plasmid gene therapy, JVS-100, improves cardiac structure, function, serum biomarkers, and clinical status in patients with severe ischemic heart failure one year after treatment. Final 12-month results from the Phase 2 STOP-HF clinical trial were presented in a late-breaking oral presentation at the European Society of Cardiology - Heart Failure 2015 and is in press at the European Heart Journal.
Marc Penn, M.D., Ph.D., FACC, Founder and Chief Medical Officer for Juventas and Director of Cardiovascular Research and Cardiovascular Medicine Fellowship at Summa Health in Akron, Ohio presented the results of the randomized, double-blind, placebo controlled STOP-HF trial that was performed in 93 patients at 16 clinical centers in the United States.
"The results from STOP-HF demonstrate that a single administration of 30 mg of JVS-100 has the potential to improve cardiac function, structure, serum biomarkers and clinical status in a population with advanced chronic heart failure who are symptomatic and present with poor cardiac function," stated Dr. Penn. "These findings combined with our deep understanding of SDF-1 biology will guide future clinical trials in which we plan to prospectively study the patient population that demonstrated the most pronounced response to JVS-100. In addition, we will further our understanding of JVS-100 by determining if a second administration of drug may enhance benefits beyond those we observed with a single administration."
JVS-100 is a non-viral DNA plasmid gene therapy that encodes stromal cell-derived factor 1 (SDF-1), a naturally occurring signaling protein. When delivered directly to a site of tissue injury, JVS-100 induces expression of SDF-1 protein into the local environment for a period of approximately three weeks. The secretion of SDF-1 has been shown to create a homing signal that recruits the body's own stem cells to the site of injury to induce tissue repair and regeneration. Juventas is developing JVS-100 for treatment of advanced chronic cardiovascular disease, including heart failure and late stage peripheral artery disease.
"The magnitude and confluence of improvements in key cardiac parameters as observed in STOP-HF have historically translated to reductions in heart failure hospitalizations and mortality in larger studies," added Dr. Penn. "We believe repairing heart tissue in a way that leads to improved function, as we have done with JVS-100, is critical for improving outcomes for these difficult to treat patients who live with the symptoms of chronic heart failure daily."
In the full study population patients receiving the 30 mg dose demonstrated improvements at 12 months after treatment in objective measures of cardiac function and structure relative to placebo-treated patients as measured by median change in left ventricle ejection fraction, LVEF (3.5% over placebo) and left ventricular end-systolic volume, or LVESV (8.5 ml over placebo). A composite score comprising change from baseline in six-minute walk distance and the Minnesota Living with Heart Failure Questionnaire also showed a trend toward improved clinical status for 30 mg JVS-100 treated patients (2.5 points); however, the increase in the composite score in patients that receive placebo (2.0 points) led to the trial missing its primary end-point at 4 months. Importantly, as in other trials with JVS-100 there were no unanticipated serious adverse events related to the drug reported for the study.
A pre-specified sub-analysis evaluating JVS-100 in patients with the lowest tertile LVEF at the time of enrollment, demonstrated an 11% increase (p<0.01) in LVEF 1 year after patients received 30 mg of JVS-100. In this high risk group of patients, 30 mg of JVS-100 also led to clinically meaningful improvements in LVESV of -34 ml, NTproBNP of -784 pg/ml and stroke volume of 25 ml. These same patients demonstrated a clinically meaningful improvement in composite score of 2.5, compared 1.2 in the placebo treated group. These patients had a baseline LVEF of 26%, placing them in a severe heart failure population with a 40% two year mortality rate.
About Juventas Therapeutics
Juventas Therapeutics is a clinical stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body. Our initial focus is the treatment of advanced chronic cardiovascular diseases with significant unmet medical needs, including advanced heart failure and late stage peripheral artery disease, or PAD. Our lead product candidate, JVS-100, is a non-viral gene therapy that expresses Stromal cell-Derived Factor-1, or SDF-1, a naturally occurring signaling protein that has been shown to recruit the body's own stem cells to promote tissue repair in a broad range of disease states. Juventas was founded in 2007 with an exclusive license from the Cleveland Clinic. Investors include Triathlon Medical Ventures, Venture Investors, Fletcher Spaght Ventures, New Science Ventures, Early Stage Partners, Reservoir Venture Partners, The Cleveland Clinic, Takeda Ventures, Green Cross Holdings Corporation and POSCO Capital. For more information about Juventas please visit www.juventasinc.com.
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