Date: 2015-06-16
Type of information: Clinical trial autorization
phase: 2b
Announcement: clinical trial authorization
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. Study drug was administered directly to the heart via the BioCardia Helical Infusion Catheter (HIC), which is being developed by BioCardia, Inc., of San Carlos, Calif. The system is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart.
Disease: advanced ischemic chronic heart failure in patients with a prior history of heart attack
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: The STOP-HF2 trial is expected to enroll up to 180 patients at as many as 40 clinical centers in a double-blinded, 1:1 randomized, sham-controlled study evaluating the impact of two administrations of 30 mg doses of JVS-100 in heart failure patients with low ejection fraction (≤ 35%) and elevated serum biomarkers (NTproBNP ≥ 500 pg/mL). The first dose will be delivered at the time of patient enrollment and the second will be delivered six months later, each by endomyocardial injection catheter to the left ventricle of the heart.
Latest
news: * On June 16, 2015, Juventas Therapeutics, a clinical-stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body announced that the FDA has also allowed the protocol for the company’s Phase 2b double-blinded, randomized clinical trial of JVS-100 for the treatment of advanced ischemic chronic heart failure in patients with a prior history of heart attack, referred to as STOP-HF2. The STOP-HF2 trial is expected to enroll up to 180 patients at as many as 40 clinical centers in a double-blinded, 1:1 randomized, sham-controlled study evaluating the impact of two administrations of 30 mg doses of JVS-100 in heart failure patients with low ejection fraction (≤ 35%) and elevated serum biomarkers (NTproBNP ≥ 500 pg/mL). The first dose will be delivered at the time of patient enrollment and the second will be delivered six months later, each by endomyocardial injection catheter to the left ventricle of the heart.
