DVC1-0101 / I’rom Group, Shenzhen Salubris - LARVOL DELTA

Randomized Phase IIb Trial of DVC1-0101 (clinicaltrials.gov) - P2b | N=30 | Active, not recruiting | Sponsor: Kyushu University | Trial completion date: Oct 2022 ➔ Aug 2024

Trial completion date • Cardiovascular • Peripheral Arterial Disease

Randomized Phase IIb Trial of DVC1-0101 (clinicaltrials.gov) - P2b | N=30 | Active, not recruiting | Sponsor: Kyushu University | Trial completion date: Feb 2022 ➔ Oct 2022

Trial completion date • Cardiovascular • Peripheral Arterial Disease

A RNA Gene Drug DVC1-0101 Based on Recombinant Sendai Virus Vector to Treat Severe Intermittent Claudication: Topline Results From Multicenter, Double-blinded, Placebo-controlled Phase IIb Clinical Trial (ASGCT 2022) - No abstract available

Clinical • P2b data

Randomized Phase IIb Trial of DVC1-0101 (clinicaltrials.gov) - P2b; N=30; Active, not recruiting; Sponsor: Kyushu University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cardiovascular • Peripheral Arterial Disease

Randomized Phase IIb Trial of DVC1-0101 (clinicaltrials.gov) - P2b; N=30; Recruiting; Sponsor: Kyushu University; N=60 ➔ 30; Trial completion date: Oct 2017 ➔ Feb 2022; Trial primary completion date: Oct 2016 ➔ Nov 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date

An Update Progress Report of Clinical Safety and Efficacy for Gene Therapy with Sendai Virus Vector Expressing the Human FGF-2 Gene (DVC1-0101) to Treat Peripheral Arterial Disease (ASGCT 2019) - "In conclusion, it must be noted that these results are extracted from a phase I/IIa with no randomization and no-placebo control, and the interim report from double-blinded trial. Thus, the findings are preliminary and must be interpreted with caution; however, the results are suggestive of DVC1-0101 possibly showing safety use in patients with peripheral arterial disease to compare natural course of death and limb salvation. The presented data may be valuable concerning rates in cancer, cardiovascular events, and inflammatory diseases following angiogenesis gene therapy in the absence of any long-term data."

Clinical