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INSM - Insmed - Deel 15

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  1. ludwig mack 25 juni 2007 22:24
    Last Trade: 0.76
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  2. [verwijderd] 26 juni 2007 12:43

    Even ter informatie

    childhood epidemic of blindness"( ROP) in South America June 2007

    Bouzas L, Bauer G, Novali L, Dilger A, Galina L, Falbo J, Díaz González L, Manzitti J, Sola A.

    Area de Neonatología y Seguimiento de Alto Riesgo. Hospital de Pediatría Garrahan. Buenos Aires. Argentina. arquerol@fibertel.com.ar.

    INTRODUCTION: Retinopathy of prematurity (ROP) is the first cause of childhood blindness in Argentina and is reaching epidemic proportions. To gain greater insight into the issues involved in this epidemic, we analyzed the characteristics of the infants referred for treatment of very severe ROP to the Dr. Juan P. Garrahan Pediatric Hospital, located in the city of Buenos Aires. METHODS: We performed a retrospective study of patients referred for ROP from 01/01/96 to 12/31/03. Very severe ROP was defined as threshold disease or worse in both eyes, plus disease in zones 1 or 2, or Rush disease. Unusual patients were defined as those with very severe ROP with a gestational age (GA) of > 31 weeks or birth weight (BW) > 1500 g. Patients were divided into two groups according to the distance between the referring center and our hospital: group A consisted of those from nearby areas (</= 70 km) and group B comprised those from areas > 70 km from the hospital. RESULTS: During the study period, the number of cases progressively increased while the proportion of "unusual" patients slightly decreased. The total number of infants referred was 809 and 14 % were unusual patients; 55 % had very severe ROP, 89 % were treated, and 7 % were referred too late and lost the opportunity for treatment. Group B comprised 61 % of the infants referred. Very severe ROP was present in 53 % of patients in group A and in 56 % of those in group B. The mean GA was 29.5 +/- 3.1 weeks in group A and 30.8 +/- 2.6 in group B (p < 0.001); 90.5 % of the patients in group A and 64 % of those in group B required mechanical ventilation (p < 0.001). No predictors for very severe ROP were found in multifactorial analysis. CONCLUSIONS: We report a childhood epidemic of blindness in which the prevalence of very severe ROP increased during the study period and the disease occurred in large, fairly mature newborns. The differences found in relation to the referring center and the lack of correlation between very severe ROP and prematurity or the use of mechanical ventilation suggests substantial disparity in healthcare, which should be taken into account when planning prevention strategies.


  3. [verwijderd] 26 juni 2007 14:22
    Hieruit blijkt dat Insmed verlopig nog geen goedkeuring had gekregen. Wat mij opvalt is dat ze nooit melding hebben gemaakt van de additionele vragen van CHMP. In ieder geval nog een reden waarom Insmed niet verder wilde gaan met IGFD en een goede leerschool voor de nieuwe indicaties.

    26/06/07 Questions and Answers on the withdrawal of the marketing authorisation application for Iplex

    www.emea.europa.eu/humandocs/Humans/E...

    26/06/07 Withdrawal Assessment Report for Iplex

    www.emea.europa.eu/humandocs/PDFs/EPA...
  4. [verwijderd] 26 juni 2007 15:30
    Insmed Inc. Welcomes Studies Linking IGFBP-3 to Prevention of Blindness in Premature Infants
    Key Protein in Company's Drug IPLEX(TM) is Seen Playing Lead Role in Development of Healthy Eyesight
    RICHMOND, Va., Jun 26, 2007 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq:INSM), a biopharmaceutical company focused on the development and approval of drugs for the treatment of metabolic diseases with unmet medical needs, today noted the publication of promising results of research from three universities regarding the potential role of insulin-like growth factor binding protein-3 (IGFBP-3) in the prevention of blindness among premature infants.

    IGFBP-3 is a key component of Insmed's lead drug candidate, IPLEX(TM), which has been approved by the U.S. Food and Drug Administration for the treatment of a severe growth disorder and is currently being studied as a treatment for myotonic muscular dystrophy, HIV-associated adipose redistribution syndrome and retinopathy of prematurity (ROP). IPLEX(TM) is the combination of IGFBP-3 with recombinant human insulin-like growth factor 1 (IGF-I).

    The new study results, published in the June 19 issue of the Proceedings of the National Academy of Sciences, focus on the action of IGFBP-3 in promoting normal tissue growth and preventing ROP. Researchers at the University of Florida reported that mice treated with IGFBP-3 showed closer-to-normal growth of retinal vasculature than mice without IGFBP-3 in similar high-oxygen conditions. Researchers at Harvard Medical School and the University of Goteborg in Sweden reported similar results.

    In addition, Harvard Medical School researchers, in collaboration with researchers at the University of Goteborg, reported results of a clinical study showing IGFBP-3 levels in infants with ROP were lower than those of healthy babies. The researchers said these results suggest that IGFBP-3, acting independently of IGF-I, helps prevent oxygen-induced loss of blood-vessels and helps promote vascular re-growth.

    Insmed Chairman and CEO Geoffrey Allan, Ph.D., commented: "These studies by researchers at three distinguished universities mark an important scientific milestone in Insmed's development of IPLEX(TM) as a treatment for ROP. They suggest that IGFBP-3, once thought only to regulate IGF-I, actually plays a broader role in human development and in the growth or regeneration of human tissues. Not only is this discovery important in the fight against ROP, but it also suggests promising avenues for research into the treatment of other conditions associated with ischemia and vascular damage."

  5. [verwijderd] 26 juni 2007 16:13
    quote:

    crackedtooth schreef:

    [quote=Peermanpaapskop]
    Dat geeft de burger moed (en de koers ook trouwens)
    [/quote]

    is voorla significatn omdat ze nu EINDELIJK doorHebben dat ze externe onderzoeken wel degelijk als een PR publiekelijk kunnen maken
    Ja, zouden ze nu eindelijk eens wakker worden?
  6. ludwig mack 27 juni 2007 17:10
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