CONSCIOUS-2 study with clazosentan does not meet primary endpoint
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ALLSCHWIL/BASEL, SWITZERLAND - 27 September 2010 - Actelion Ltd (SIX: ATLN)
announced today the initial results of CONSCIOUS-2 a clinical study evaluating
the safety and efficacy of clazosentan in reducing vasospasm-related morbidity
and all-cause mortality in clipped patients following aneurysmal subarachnoid
hemorrhage (aSAH).
The primary endpoint showed a non-significant relative risk reduction of 17
percent in favor of clazosentan (p=0.1). The safety profile of clazosentan in
CONSCIOUS-2 was comparable to previous studies with the compound in this
disease.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "These
are, of course, disappointing results. Having embarked upon such a complex
study, both in terms of design and execution, I must commend the exceptional
efforts of all involved delivering a high-quality study."
Jean-Paul Clozel continued: "Actelion will continue to focus on growing its
existing business. With four marketed products, Actelion is generating the
necessary revenues to continue to invest appropriately in clinical studies for
our more than 10 development compounds."
In regards to the ongoing CONSCIOUS-3 study in patients with aSAH that underwent
coiling to secure their aneurysm, Actelion will discuss the appropriate course
of action with the Steering Committee. The company will provide an update on the
clazosentan development program in its upcoming Q3 reporting, scheduled for
Thursday, 21 October 2010.
About CONSCIOUS-2
CONSCIOUS-2 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring
after Subarachnoid hemorrhage) investigated the potential clinical benefits of
clazosentan through the primary endpoint of vasospasm-related morbidity and
all-cause mortality, which includes neurological deterioration, new brain
infarcts, introduction of vasospasm rescue therapy, or death from any cause.
CONSCIOUS-2 was a global study which concluded enrollment with over 1,150
patients with aSAH and aneurysmal surgical clipping, from more than 100 centers.
Patients were randomized 2:1 to receive either 5 mg/h of clazosentan, or
placebo.
###
Notes to the Editor
About Cerebral vasospasm as a consequence of aneurysmal subarachnoid hemorrhage
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening condition
affecting over 85,000 people in the EU, US and Japan every year. This condition
occurs when the rupture of an aneurysm on the cerebral vessels leads to release
of blood into the subarachnoid space of the brain. Endovascular coiling or
microsurgical clipping is usually required to stop the bleeding and prevent
further episodes.
Cerebral vasospasm following SAH causes the intracranial arteries to constrict
thus diminishing blood flow to the brain. It is a significant predictor of poor
outcome and the leading potentially treatable cause of mortality and morbidity
in these patients. Vasospasm is unpredictable in nature and seen in over 67% of
untreated patients with angiography at the time of maximum spasm, around the end
of the first week. It becomes symptomatic in about half of these patients.
Currently, there is no effective treatment for the prevention and treatment of
the severe complications following vasospasm.
About CONSCIOUS-3
CONSCIOUS-3 is a Phase III study evaluating the efficacy and safety of two doses
(5 or 15 mg/h) of clazosentan versus placebo in patients post-aSAH treated by
endovascular coiling. The primary endpoint is identical to that of CONSCIOUS 2.
Until the end of September 2010, the study enrolled close to 600 patients out
of 1500 planned.
About CONSCIOUS-1
CONSCIOUS-1 was a multi-center, international, double-blind, randomized,
placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy
of three dose levels of clazosentan (15, 5 and 1mg/hour) in preventing the
occurrence of cerebral vasospasm following aSAH in patients who underwent either
clipping or coiling to stop the initial bleed, assessed by angiography.
CONSCIOUS-1 showed a strong treatment effect on the primary endpoint.
Clazosentan significantly reduced moderate/severe vasospasm at all tested doses,
with a relative risk reduction compared to placebo of 65% at the highest dose. A
post-hoc analysis showed a trend in favor of reducing morbidity/mortality
related to vasospasm using central assessment.
In the study, treatment with clazosentan was associated with more adverse events
than placebo, mainly related to vasodilatory effects such as hypotension and
fluid retention.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States, the European
Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late
1997, is a leading player in innovative science related to the endothelium - the
single layer of cells separating every blood vessel from the blood stream.
Actelion's over 2,400 employees focus on the discovery, development and
marketing of innovative drugs for significant unmet medical needs. Actelion
shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the
Swiss blue-chip index SMI (Swiss Market Index SMI®).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public AffairsActelion
Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com
[HUG#1446888]
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
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Unternehmensinformation / Kurzprofil:
Datum: 27.09.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 43043
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