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     2554  0 Kommentare Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension


    Novartis International AG /
    Novartis study shows QTI571 significantly improved walking distance in patients
    with life-threatening pulmonary arterial hypertension
    . Processed and transmitted by Thomson Reuters ONE.
    The issuer is solely responsible for the content of this announcement.

    * Phase III IMPRES study demonstrates potential benefits of QTI571 in patients
    who remain symptomatic despite treatment with two or more PAH therapies[1]
    * Evidence indicates that QTI571 targets an underlying cause of PAH by
    counteracting uncontrolled growth of arterial smooth muscle cells[2]
    * PAH is a debilitating disease of the heart and lungs affecting up to
    260,000 people worldwide[3] leading to heart failure and death[4], [5]

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    Basel, September 25, 2011 - Novartis announced new data today from the pivotal
    Phase III IMPRES clinical trial showing that the investigational therapy QTI571
    (imatinib) significantly improved exercise capacity in patients with pulmonary
    arterial hypertension (PAH) after 24 weeks compared with placebo[1]. Evidence
    indicates that QTI571 targets an underlying cause of PAH by counteracting
    uncontrolled growth of arterial smooth muscle cells[2].

    The IMPRES study met its primary endpoint by demonstrating a significant
    improvement in the six-minute walk distance (6MWD) test in patients with
    elevated pulmonary vascular resistance (PVR) despite treatment with two or more
    specific PAH vasodilator therapies[1]. The 6MWD is a predictor of survival in
    PAH patients[6], [7], and is commonly used to assess exercise capacity in PAH
    clinical trials[8], [9], [10]. In the study, patients treated with QTI571
    increased their mean 6MWD by 31.8 meters compared with placebo (p=0.002)[1].

    The study´s secondary endpoints showed that QTI571 produced statistically
    significant improvements compared to placebo in pulmonary arterial pressure,
    cardiac output and pulmonary vascular resistance (all p<0.001)[1], but not in
    time to clinical worsening (i.e. death, hospitalization due to PAH, worsening of
    functional class, or >=15% drop in 6MWD) (p=0.563)[1].

    "These results are impressive as they were achieved in patients who were already
    receiving two or more established PAH drugs, " said Marius Hoeper MD, Associate
    Professor, Department of Respiratory Medicine at Hannover Medical School,
    Germany and principal investigator of the IMPRES study. The data were presented
    for the first time at the European Respiratory Society (ERS) Annual Congress in
    Amsterdam, The Netherlands.

    PAH is a debilitating disease of the heart and lungs that is characterized by a
    marked and sustained elevation in pulmonary artery pressure. The disease is

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    Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension Novartis International AG / Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible …

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