Development of a liver-targeted siRNA delivery platform with a broad therapeutic window utilizing biodegradable polypeptide-based polymer conjugates

J Control Release. 2014 Jun 10:183:124-37. doi: 10.1016/j.jconrel.2014.03.028. Epub 2014 Mar 21.

Abstract

The greatest challenge standing in the way of effective in vivo siRNA delivery is creating a delivery vehicle that mediates a high degree of efficacy with a broad therapeutic window. Key structure-activity relationships of a poly(amide) polymer conjugate siRNA delivery platform were explored to discover the optimized polymer parameters that yield the highest activity of mRNA knockdown in the liver. At the same time, the poly(amide) backbone of the polymers allowed for the metabolism and clearance of the polymer from the body very quickly, which was established using radiolabeled polymers to demonstrate the time course of biodistribution and excretion from the body. The fast degradation and clearance of the polymers provided for very low toxicity at efficacious doses, and the therapeutic window of this poly(amide)-based siRNA delivery platform was shown to be much broader than a comparable polymer platform. The results of this work illustrate that the poly(amide) platform has a promising future in the development of a siRNA-based drug approved for human use.

Keywords: Biodegradable; Delivery vehicle; Gene delivery; Polypeptide.

MeSH terms

  • Animals
  • Autoradiography
  • Biocompatible Materials / chemical synthesis*
  • Biocompatible Materials / chemistry
  • Biocompatible Materials / pharmacokinetics
  • Biocompatible Materials / toxicity
  • Drug Carriers / chemical synthesis*
  • Drug Carriers / chemistry
  • Drug Carriers / pharmacokinetics
  • Drug Carriers / toxicity
  • Drug Design
  • Drug Stability
  • Female
  • Hep G2 Cells
  • Hepatocytes / metabolism
  • Humans
  • Liver / diagnostic imaging
  • Liver / metabolism*
  • Macaca mulatta
  • Nylons / chemical synthesis*
  • Nylons / chemistry
  • Nylons / pharmacokinetics
  • Nylons / toxicity
  • Peptides / chemical synthesis*
  • Peptides / chemistry
  • Peptides / pharmacokinetics
  • Peptides / toxicity
  • RNA, Small Interfering / administration & dosage*
  • RNA, Small Interfering / genetics
  • RNA, Small Interfering / pharmacokinetics
  • RNA, Small Interfering / toxicity
  • Radionuclide Imaging
  • Rats, Sprague-Dawley
  • Species Specificity
  • Structure-Activity Relationship
  • Tissue Distribution

Substances

  • Biocompatible Materials
  • Drug Carriers
  • Nylons
  • Peptides
  • RNA, Small Interfering