Date: 2014-11-18
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Heart Association Scientific Sessions 2014
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: critical limb ischemia (CLI)
Therapeutic area: Cardiovascular diseases
Country: India, USA
Trial
details: This double-blind, placebo controlled study is designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).(NCT01410331)
Latest
news: * On November 18, 2014, Juventas Therapeutics, a privately-held, clinical-stage company developing novel therapies for treatment of cardiovascular disease, had clinical data presented at the American Heart Association Scientific Sessions 2014 that show JVS-100 was safe and well tolerated while demonstrating clinically meaningful improvement in patients with critical limb ischemia (CLI). Melina Kibbe, MD, of Northwestern University Feinberg School of Medicine, presented the data, marking the first public presentation of this data. The primary objectives of the study were to evaluate the safety and tolerability of escalating doses of JVS-100, a non-viral gene therapy expressing stromal cell-derived factor 1 (SDF-1), delivered via direct intramuscular injection to patients with CLI. STOP-CLI is a phase IIa, randomized, double blind, placebo-controlled dose escalation study to evaluate the safety and initial efficacy of JVS-100 in patients with CLI. With 48 subjects enrolled, JVS-100 met its primary safety endpoint and demonstrated consistent, dose-dependent improvement relative to placebo across multiple clinical efficacy parameters. STOP-CLI data shows: JVS-100 delivery by intramuscular injection to subjects with CLI was safe with no unanticipated drug-related serious adverse events (SAEs). Patients treated with JVS-100 demonstrated consistent dose-dependent improvement across multiple clinical efficacy parameters, including quality of life (QoL), pain reduction and ulcer closure. There was no significant difference in amputation rates between the placebo and JVS-100 treated patients. The overall amputation rate for the study was less than 10% and larger studies will be needed to understand the effect of JVS-100 on amputation free survival.
