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.

Articles

Retina

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.