JVS-100 / Juventas Therap, Astellas - LARVOL DELTA

Juventas Therapeutics doses first patient in Phase 2 STOP-HF trial (PRNewswire) - P1, N=17; NCT01082094; Juventas reported 12-month results from P1 clinical trial in NYHA class 3 HF pts; In addition to meeting the primary safety endpoint, pts receiving target therapeutic doses demonstrated clinically significant improvement at 12 months in 6MWD & the MLHFQ; P2, N=90; STOP-HF; Juventas reports treating the first patient in STOP-HF trial

P1 data • Trial status • Heart Failure

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure (clinicaltrials.gov) - P1/2; N=72; Active, not recruiting; Sponsor: Juventas Therapeutics, Inc.; Recruiting -> Active, not recruiting ; Trial primary completion date: Oct 2014 ->Aug 2015

Enrollment closed • Trial primary completion date • Acute Coronary Syndrome • Biosimilar • Dyslipidemia • Heart Failure • Reperfusion Injury

Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by trans-endocardial injection in patients with ischemic cardiomyopathy: The POSEIDON randomized trial (JAMA) - P1/2, N=30; NCT01087996; In pts with ICM, transendocardial injection of allogeneic & autologous MSCs without a PBO control were both associated with low rates of treatment-emergent SAEs, including immunologic reactions; In aggregate, MSC injection favorably affected patient functional capacity, QOL & ventricular remodeling

P1/2 data • Heart Failure

Intra-tracheal administration of a naked plasmid expressing stromal derived factor-1 improves lung structure in rodents with experimental bronchopulmonary dysplasia. (PubMed, Respir Res) - "Intratracheal administration of a naked plasmid expressing SDF-1 improves alveolar and vascular structure in an experimental model of BPD. These findings suggest that therapies which modulate lung SDF-1 expression may have beneficial effects in preterm infants with BPD."

Journal • Bronchopulmonary Dysplasia • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Ophthalmology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial. (PubMed, Vasc Med) - P2b; "...Using a novel design, we examined the impact of complementing revascularization therapy with intramuscular JVS-100 - a non-viral gene therapy that activates endogenous regenerative repair pathways...Only one-quarter of CLI wounds healed at 3 months despite successful revascularization, highlighting the need for additional research in therapies that can improve microcirculation in these patients. ClinicalTrials.gov Identifier: NCT02544204."

Clinical • Journal