Pharmacokinetic evaluation of oblimersen sodium for the treatment of chronic lymphocytic leukemia

Expert Opin Drug Metab Toxicol. 2011 Jun;7(6):765-74. doi: 10.1517/17425255.2011.579105. Epub 2011 Apr 27.

Abstract

Introduction: Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the western hemisphere. Developing new therapies remains a priority as present treatment options do not offer a cure. BCL-2 overexpression in CLL is associated with aggressive disease features and resists chemotherapy. Oblimersen sodium (G3139) is a phosphorothioate oligonucleotide antisense drug targeting the BCL-2 mRNA and is the first antisense to reach advanced clinical testing in oncology. Preclinical evaluation has demonstrated good antineoplastic effect in B-cell cancers; several clinical trials have confirmed its safety and efficacy both alone and in combination with other therapeutics.

Areas covered: This review focuses on the chemistry, pharmacodynamics, pharmacokinetics and clinical evaluation of oblimersen in CLL. PubMed and MEDLINE searches assisted in data collection.

Expert opinion: Bcl-2 is an important target in CLL. Antisense therapy is a novel approach to target oncoproteins; this can be beneficial in the clinical setting. Oblimersen sodium demonstrates the clinical safety of the antisense therapeutic approach and, with chemotherapy, shows survival advantage in a subset of CLL patients. However, future approval of oblimersen sodium in CLL remains uncertain. Nevertheless, BCL-2 remains a critical target in drug development and is an area of high-priority research.

Publication types

  • Review

MeSH terms

  • Antineoplastic Agents / pharmacokinetics*
  • Antineoplastic Agents / therapeutic use
  • B-Lymphocytes / metabolism
  • Clinical Trials as Topic
  • Dose-Response Relationship, Drug
  • Down-Regulation
  • Drug Evaluation*
  • Drug Evaluation, Preclinical
  • Drug and Narcotic Control / legislation & jurisprudence
  • Gene Expression Regulation, Neoplastic
  • Genes, bcl-2
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
  • Proto-Oncogene Proteins c-bcl-2 / genetics
  • RNA, Messenger / genetics
  • Thionucleotides / pharmacokinetics*
  • Thionucleotides / therapeutic use

Substances

  • Antineoplastic Agents
  • Proto-Oncogene Proteins c-bcl-2
  • RNA, Messenger
  • Thionucleotides
  • oblimersen