RICHMOND, Va. and UPPSALA, Sweden, Sept. 23 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq CM: INSM), a developer of follow-on biologics (FOBs) and biopharmaceuticals, and Premacure AB, a biopharmaceutical company dedicated to the development of diagnosis and prevention of complications in neonates due to premature birth, today noted the presentation of clinical study results demonstrating that Insmed's IPLEX(TM) product, a complex of recombinant human insulin-like growth factor (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3), increased serum IGF-I levels into the normal range in significantly premature infants. Premacure is developing IPLEX(TM) as a potential treatment for Retinopathy of Prematurity (ROP) via a Material Transfer Agreement with Insmed.
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These most recent study results were reported today at the European Society for Pediatric Endocrinology 47th annual meeting, Istanbul, Turkey, by Investigators from the Harvard Medical School, Boston MA, and the University of Gothenburg, The Karolinska Institute, Stockholm, Lund University, Sweden, in a poster entitled "Pharmacokinetic study of recombinant human (rh) insulin-like growth factor/rh IGFBP-3 complex administered to very low birth weight infants."
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"The possibility of preventing ROP and other complications of prematurity by replicating the in utero environment after infants are born prematurely and lose the factors normally provided by the maternal environment is very exciting," said Lois Smith, Professor of Ophthalmology, Harvard Medical School, Children's Hospital Boston. "This work showing that it is now possible to raise the serum level of IGF-1 and IGFBP-3 to normal in utero levels in these fragile infants with IGF-1 / IGFBP-3 deficiency is a critical step in the development of interventions that prevent ROP. Since we have shown that low IGF-1 is associated with ROP, this offers the first possible intervention to prevent this blinding disease."
"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(
