Efficacy and safety of mecasermin rinfabate.

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.

• Authors: Stephen F Kemp, John L Fowlkes, Kathryn M Thrailkill
• Journal: Expert opinion on biological therapy (Expert Opin Biol Ther) Vol. 6 Issue 5 Pg. 533-8 (May 2006) ISSN: 1744-7682 [Electronic] England
• PMID: 16610982 (Publication Type: Journal Article)

Chemical References

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

Topics

• 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, therapeutic use)
• Insulin-Like Growth Factor I (adverse effects, pharmacokinetics, therapeutic use)
• Recombinant Fusion Proteins (adverse effects, pharmacokinetics, therapeutic use)
• Recombinant Proteins