ROP treatment proves its worth

September 29, 2008

Intravenous administration of IPLEX, Insmed Inc's rhIGF-I/rhIGFBP-3 complex, is well-tolerated and efficacious in significantly premature infants, according to Phase I study results announced at this year's European Society for Paediatric Endocrinology meeting, held 20?23 September in Istanbul, Turkey.

Intravenous administration of IPLEX, an rhIGF-I/rhIGFBP-3 complex, is well-tolerated and efficacious in significantly premature infants for the treatment of retinopathy of prematurity (ROP), according to Phase I study results announced at this year's European Society for Paediatric Endocrinology meeting, held 20–23 September in Istanbul, Turkey.

IPLEX's combination of recombinant human insulin-like growth factor (rhIGF-I) with its predominant binding protein IGFBP-3 (rhIGFBP-3) is designed to treat ROP by increasing to normal the low serum levels of the protein IGF- I in low-birth-weight premature neonatal subjects.

The open-label study evaluated the effect of the treatment on infants born between 26 weeks + 0 days and 29 weeks + 1 day of gestation (n=5). Birth weight ranged from 810 to 1310 g, and all subjects received an intravenous dose of IPLEX three days after birth. In all subjects, serum levels of IGF-I were raised to within the normal physiological range for non-premature infants. No acute adverse events were noted.

The developers of IPLEX, plans to initiate a Phase II multicentre study before the end of the year. If found to be safe, well-tolerated and clinically effective, IPLEX may offer a more effective ROP treatment option than current methods, which tend to be highly invasive and focus only on arresting disease progression rather than reversing previous damage.