Pharmacokinetics, brain delivery, and efficacy in brain tumor-bearing mice of glutathione pegylated liposomal doxorubicin (2B3-101)

PLoS One. 2014 Jan 8;9(1):e82331. doi: 10.1371/journal.pone.0082331. eCollection 2014.

Abstract

Brain cancer is a devastating disease affecting many people worldwide. Effective treatment with chemotherapeutics is limited due to the presence of the blood-brain barrier (BBB) that tightly regulates the diffusion of endogenous molecules but also xenobiotics. Glutathione pegylated liposomal doxorubicin (2B3-101) is being developed as a new treatment option for patients with brain cancer. It is based on already marketed pegylated liposomal doxorubicin (Doxil®/Caelyx®), with an additional glutathione coating that safely enhances drug delivery across the BBB. Uptake of 2B3-101 by human brain capillary endothelial cells in vitro was time-, concentration- and temperature-dependent, while pegylated liposomal doxorubicin mainly remained bound to the cells. In vivo, 2B3-101 and pegylated liposomal doxorubicin had a comparable plasma exposure in mice, yet brain retention 4 days after administration was higher for 2B3-101. 2B3-101 was overall well tolerated by athymic FVB mice with experimental human glioblastoma (luciferase transfected U87MG). In 2 independent experiments a strong inhibition of brain tumor growth was observed for 2B3-101 as measured by bioluminescence intensity. The effect of weekly administration of 5 mg/kg 2B3-101 was more pronounced compared to pegylated liposomal doxorubicin (p<0.05) and saline (p<0.01). Two out of 9 animals receiving 2B3-101 showed a complete tumor regression. Twice-weekly injections of 5 mg/kg 2B3-101 again had a significant effect in inhibiting brain tumor growth (p<0.001) compared to pegylated liposomal doxorubicin and saline, and a complete regression was observed in 1 animal treated with 2B3-101. In addition, twice-weekly dosing of 2B3-101 significantly increased the median survival time by 38.5% (p<0.001) and 16.1% (p<0.05) compared to saline and pegylated liposomal doxorubicin, respectively. Overall, these data demonstrate that glutathione pegylated liposomal doxorubicin enhances the effective delivery of doxorubicin to brain tumors and could become a promising new therapeutic option for the treatment of brain malignancies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Body Weight / drug effects
  • Brain / blood supply
  • Brain / drug effects
  • Brain / pathology*
  • Brain Neoplasms / drug therapy*
  • Brain Neoplasms / pathology
  • Brain Neoplasms / ultrastructure
  • Capillaries / pathology
  • Cell Proliferation / drug effects
  • Doxorubicin / analogs & derivatives*
  • Doxorubicin / blood
  • Doxorubicin / pharmacokinetics
  • Doxorubicin / pharmacology
  • Doxorubicin / therapeutic use
  • Drug Delivery Systems*
  • Endothelial Cells / metabolism
  • Endothelial Cells / pathology
  • Female
  • Glioblastoma / drug therapy
  • Glioblastoma / pathology
  • Glutathione / analogs & derivatives*
  • Glutathione / blood
  • Glutathione / pharmacokinetics
  • Glutathione / pharmacology
  • Glutathione / therapeutic use
  • Humans
  • Mice
  • Mice, Nude
  • Polyethylene Glycols / pharmacokinetics
  • Polyethylene Glycols / pharmacology
  • Polyethylene Glycols / therapeutic use
  • Survival Analysis
  • Time Factors
  • Tissue Distribution / drug effects
  • Treatment Outcome

Substances

  • glutathione pegylated liposomal doxorubicin
  • liposomal doxorubicin
  • Polyethylene Glycols
  • Doxorubicin
  • Glutathione