Efficacy and safety of mecasermin rinfabate

Expert Opin Biol Ther. 2006 May;6(5):533-8. doi: 10.1517/14712598.6.5.533.

Abstract

There has been interest in using recombinant human (rh) insulin-like growth factor (IGF)-I (rhIGF-I) to treat short stature, either alone or in combination with its binding protein (insulin-like growth factor binding protein [IGFBP]-3). IGF-I has been shown to increase growth velocity in children with IGF deficiency, either as a result of growth hormone insensitivity syndrome (GHIS) or IGF gene deletion. However, there have been adverse events, particularly hypoglycaemia, reported with administration of unbound rhIGF-I. In addition, the serum half-life of unbound rhIGF-I is shorter when administered to patients with GHIS, who have low serum concentrations of its binding proteins IGFBP-3 and acid-labile subunit (ALS), than when administered to normal volunteers or to the patient with an IGF-I gene deletion (who had normal levels of IGFBP-3). iPlex (mecasermin rinfabate), an equimolar mixture of IGF-I and its binding protein IGFBP-3, was developed to prolong the half-life and to counteract acute adverse events (particularly hypoglycaemia) associated with administration of IGF-I. Although there are no published data on the efficacy of mecasermin rinfabate in treating growth disorders, it does appear that mecasermin rinfabate has a longer half-life in patients with GHIS than unbound IGF-I, and fewer reports of adverse events (including hypoglycaemia) when administered to patients with diabetes.

MeSH terms

  • Burns / drug therapy
  • Clinical Trials as Topic
  • Diabetes Mellitus / drug therapy
  • Drug Combinations
  • Growth Disorders / drug therapy*
  • Humans
  • Insulin-Like Growth Factor Binding Protein 3 / pharmacokinetics
  • Insulin-Like Growth Factor Binding Protein 3 / therapeutic use*
  • Insulin-Like Growth Factor I / adverse effects
  • Insulin-Like Growth Factor I / pharmacokinetics
  • Insulin-Like Growth Factor I / therapeutic use*
  • Recombinant Fusion Proteins / adverse effects
  • Recombinant Fusion Proteins / pharmacokinetics
  • Recombinant Fusion Proteins / therapeutic use*
  • Recombinant Proteins

Substances

  • Drug Combinations
  • Insulin-Like Growth Factor Binding Protein 3
  • Recombinant Fusion Proteins
  • Recombinant Proteins
  • somatoKine
  • Insulin-Like Growth Factor I