Gene therapy for peripheral arterial disease using sendai virus vector: From preclinical studies to the phase I/IIa clinical trial

Yoshikazu Yonemitsu, Takuya Matsumoto, Yoshihiko Maehara

Research output: Chapter in Book/Report/Conference proceedingChapter

3 Citations (Scopus)

Abstract

Great potential for limb salvaging with basic fibroblast growth factor (FGF-2) expressed from a Sendai virus vector with the full-length viral genome (SeV/FGF-2) in the target muscle was demonstrated in animal models of severe limb ischemia. The exogenously expressed FGF-2 induced other endogenous angiogenic factors, including vascular endothelial growth factor and hepatocyte growth factor in a highly concerted fashion, and this was shown to underlie the remarkable limb salvaging. These results led to the initiation of a phase I/IIa clinical trial for peripheral arterial disease (PAD) of humans. To be better prepared for unforeseen adverse events, this clinical trial used the F gene-deleted, nontransmissible, and hence safer (than SeV/FGF-2) version that carried the human FGF-2 gene (ΔFSeV/FGF-2; product code, DVC1-0101). Overall, DVC1-0101 appeared to be safe, giving rise to no serious adverse events in various criteria. Moreover, it exerted a significant therapeutic effect from a number of clinical aspects. DVC1-0101 represents the first case of the potential diverse medical applications of SeV vector. It is now hoped to move on to an advanced phase of clinical trial with a larger number of patients and placebo group to firmly establish the safety and efficacy of DVC1-0101.

Original languageEnglish
Title of host publicationSendai Virus Vector
Subtitle of host publicationAdvantages and Applications
PublisherSpringer Japan
Pages185-199
Number of pages15
ISBN (Electronic)9784431545569
ISBN (Print)4431545557, 9784431545552
DOIs
Publication statusPublished - Sep 1 2013

All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Immunology and Microbiology(all)

Fingerprint Dive into the research topics of 'Gene therapy for peripheral arterial disease using sendai virus vector: From preclinical studies to the phase I/IIa clinical trial'. Together they form a unique fingerprint.

Cite this