Date: 2014-08-12
Type of information: Completion of patient enrollment
phase: 1-2
Announcement: completion of patient enrollment
Company: Juventas Therapeutics (USA - OH)
Product: JVS-100
Action
mechanism: gene therapy. JVS-100 is non-viral DNA plasmid that encodes Stromal–cell Derived Factor 1 (SDF-1). JVS-100 has been shown to protect and repair tissue following organ-injury in a broad range of pre-clinical disease models. Juventas Therapeutics 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.
Disease: ischemic heart failure
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: The phase I/II study will evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.(NCT01961726)
Latest
news: * On August 12, 2014, Juventas Therapeutics, a private clinical-stage company developing a drug-based approach to regenerative medicine today announced that it successfully completed the Phase I arm of the RETRO-HF clinical trial, and fully enrolled the Phase II arm that is evaluating the safety and preliminary clinical efficacy for retrograde infusion of JVS-100 in patients with heart failure. "The Phase I RETRO-HF trial is the first FDA-allowed study to demonstrate that retrograde infusion can be used to safely deliver gene therapy to the heart," states Dr. Amit Patel Director of Cardiovascular Regenerative Medicine at University of Utah and co-Principal Investigator for the trial. In addition to meeting its safety endpoint, the Phase I RETRO-HF study demonstrated preliminary signs of clinical efficacy across several key parameters at four months post treatment. Clinically meaningful trends in improvement were observed over baseline in left ventricular end systolic volumes, left ventricular end diastolic volumes, left ventricular ejection fraction (LVEF), 6-minute walk distance (6MWD) and the Minnesota Living with Heart Failure Questionnaire (MLWHFQ). * On February 4, 2014, Juventas Therapeutics announced that it has initiated enrollment of the Phase II RETROHF clinical trial to evaluate safety and efficacy of JVS-100 delivered via retrograde infusion to patients with symptomatic heart failure. Coprincipal investigators for the trial are Drs. Amit Patel, M.D., Director of Cardiovascular Regenerative Medicine at the University of Utah, and Eugene Chung, M.D., Director of Heart Failure Program at the Ohio Heart and Vascular Center. This Phase II study follows the successful enrollment of the open-label, dose-escalation Phase I portion of the RETRO-HF program. The multi-center trial enrolled 12 patients with heart failure who received JVS-100 at 30 mg or 45 mg via retrograde infusion. RETRO-HF is the first clinical trial in the world to use the minimally invasive technique of retrograde infusion via the coronary sinus for delivery of a gene therapy to the heart. The randomized, double-blinded, placebo-controlled Phase II RETRO-HF trial will enroll 60 patients with symptomatic heart failure to receive JVS-100 at 30 mg or 45 mg or placebo. Heart failure affects nearly six million Americans, with an estimated annual cost to our healthcare system of $40 billion. The patients targeted for treatment with JVS-100 have advanced stages of heart failure where their therapeutic options are usually limited to a heart transplant or a mechanical assist device. The trial will enroll at 15 centers across the United States.
