Abstract

A RNA Gene Drug DVC1-0101 Based on Recombinant Sendai Virus Vector to Treat Peripheral Arterial Disease

Yoshikazu Yonemitsu, Professor, Kyushu University Graduate School of Pharmaceutical Sciences

A murine paramyxovirus, Sendai virus, was identified and its reconstitution technology has been developed in Japan (recombinant Sendai virus: rSeV). This technology has been a popular method to induce iPS cells, because of its outstanding strong gene expression and safety due to its cytoplasmic transgene expression without genotoxicity. Based on our extensive basic research, combination of rSeV and fibroblast growth factor-2 (FGF-2) (DVC1-0101) exhibited highly effective to rescue the ischemic organs, including limb ischemia; therefore, we moved to clinical studies for patients with peripheral arterial disease (PAD). Now we are conducting a Phase IIb randomized clinical trial to show the efficacy, and patient recruitment would be completed within the end of March 2020. In parallel, Phase I/IIa studies in Australia and China are now ongoing, and upcoming phase III study would be done together with these countries as the international collaboration. In this symposium, the history and future planning of R&D of DVC1-0101 would be presented.