EARLY: First PAH functional class II specific population study emphasizes need to diagnose and treat PAH early

    VIENNA, Austria, Sept. 28 /CNW Telbec/ - At the 2007 European Society of
Cardiology (ESC) congress in Vienna, Actelion Ltd (SWX: ATLN) has presented
full results from a Phase IIIb trial(1) which demonstrated that six months of
treatment with bosentan (Tracleer(R)) in patients with mildly symptomatic WHO
functional class II (FCII) Pulmonary Arterial Hypertension (PAH) significantly
delayed time to clinical worsening and reduced the number of patients
worsening to WHO functional class III/IV.
    The 185-patient EARLY (Endothelin Antagonist tRial in miLdlY symptomatic
PAH patients) study was a randomized, double blind, placebo-controlled trial
and it is the only randomized controlled trial (RCT) to study a dedicated FCII
    Results from EARLY suggest that PAH is a serious and progressive disease,
even in FCII patients who typically present with mild symptoms. The effect of
bosentan on time to clinical worsening, an important measure of disease
progression, was significant, representing a risk reduction of
77% (p =0.0114). Time to clinical worsening was defined by death;
hospitalization for PAH and symptomatic progression of PAH. The relevance of
this finding was supported by a significantly lower incidence of worsening of
functional class (3.4% vs. 13.2%, P = 0.0285) with bosentan compared to
placebo, as well as by improvement in quality-of-life indices.
    Furthermore, when compared to placebo, bosentan was shown to
significantly reduce pulmonary vascular resistance (PVR), representing a
treatment effect of -22.6% (-33.5, -10.0; p(less than) 0.0001), significantly
improve several other important hemodynamic measurements, and showed a strong
trend for an effect on exercise capacity (measured by the 6-minute walk
    The safety and tolerability profile was consistent with previous
placebo-controlled clinical trials in pulmonary arterial hypertension.
    Professor Nazzareno Galiè from the University of Bologna, Italy,
commented: "PAH is a rare but serious disease that progresses rapidly if left
untreated. The results of the EARLY study confirm for the first time that
early diagnosis and treatment of PAH have an impact on a relevant end-point
such as clinical worsening, even for those patients who present with mild
    Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, added:
"The results of the EARLY study reinforce our understanding of PAH as a
progressive and serious disease that needs to be diagnosed and treated in the
early stages. This is the third successive RCT with Tracleer(R) to provide
data that shows a significant effect on delaying time to clinical worsening, a
reflection of disease progression. This data is being used as a basis for
regulatory submissions worldwide. Actelion will continue its clinical research
program to further improve our understanding of PAH disease progression and
    Bosentan is currently licensed in Canada for the treatment of pulmonary
arterial hypertension in patients with WHO functional class III or IV primary
pulmonary hypertension, or pulmonary hypertension secondary to scleroderma or
congenital heart disease or human immunodeficiency virus in patients who did
not respond adequately to conventional therapy. In the summer of 2007,
Actelion has submitted the EARLY data to Health Authorities is presently
submitting for inclusion in the product labeling.

For further information:

For further information: Sylvie Deneault, (450) 680-2156

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