"Our research focuses on promoting neural, vascular and metabolic development in premature infants," said Ann Hellstrom, Professor in Pediatric Ophthalmology, Sahlgrenska Academy, Gothenburg, Sweden. "While in this study we are attempting to identify the benefits of IGF-I for ROP, our findings are also likely to be applicable to many aspects of complications of premature birth and could provide benefits for a lifespan."
"This is a crucial step in the clinical development of a preventative treatment against lifelong severe visual impairment or blindness in infants born preterm," said Jan Borg, CEO of Premacure. "Based in part on these results, we intend to initiate a phase II multicenter trial in the ROP indication during the fourth quarter."
"The ability of IPLEX(TM) to raise serum levels of two key proteins involved in the pathogenesis of ROP safely may offer a more effective preventive option in at-risk infants than the highly invasive and destructive treatment options of laser therapy or cryotherapy that are currently utilized to stem disease progression only," said Geoffrey Allan, President and CEO of Insmed. "We are pleased that researchers at such distinguished universities continue to see promise in IPLEX(TM) in ROP and intend to continue evaluating the drug in this indication. Moreover, these results serve as further evidence of the effectiveness of IPLEX(TM) in potentially treating some of the most under-served therapeutic populations, including Myotonic Muscular Dystrophy and Amyotrophic Lateral Sclerosis."
Clinical Study Results
Low levels of IGF-I are known to contribute to the pathogenesis of ROP.
The objectives of this open label, investigator-sponsored clinical study
were to determine whether intravenous administration of rhIGFI/rhIGFBP-3
(IPLEX(TM)) could increase serum levels of these proteins in at-risk
infants to levels seen in normal infan
|SOURCE Insmed Inc.; Premacure AB|
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