NEW MEMBER SIGN UP
  Display Name
 
  Email Address
 
  Password
 
  Password again
 
  Zip
 
Country
 
   

Close Window

Privacy Statement
BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
     
Community Login

What is this?
Biotechnology and Pharmaceutical ChannelMedical Device and Diagnostics ChannelClinical Research ChannelBioSpace Collaborative Employers
 Post Job | Search Resumes | Login

NEWSLETTERS
Free Newsletters
Archive
My eNewsletters

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

COMMUNITY
Login
Become a Member
Discussion Forums
FAQ

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

BIOTECH WORK PORTAL
Career Definitions
Labor Market Reports
Education & Training
Regions

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
BioPharm Insight

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

  News | News By Subject | News by Disease News By Date | Search News
   

Actelion Ltd. (SW:ATLN) Preliminary Results Of CONSCIOUS-1 Shows Significant Reduction Of Cerebral Vasospasm In Patients With Aneurysmal Subarachnoid Hemorrhage; Primary Endpoint Achieved
6/19/2006

ALLSCHWIL, Switzerland, June 19, 2006 (PRIMEZONE) -- Actelion Ltd. (Other OTC:ALIOF) (SWX:ATLN) announced today that preliminary analysis of the dose-finding study CONSCIOUS-1 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) indicates that all three doses of i.v clazosentan tested (15, 5 and 1 mg/hour) have reached statistical significance versus placebo for the primary endpoint, the reduction in the occurrence of moderate or severe cerebral vasospasm, as measured by cerebral angiography at day 9 (plus/minus 2 days) post-aneurysm rupture compared to placebo.

The effect was dose-related and most significantly seen with the dose of 15 mg/hour, a relative risk reduction compared to placebo of 65 percent (p less than 0.0001). In the study, the significant reduction in cerebral vasospasm did not translate into an overall clinical benefit as assessed by the chosen key secondary composite endpoint: occurrence of morbidity/mortality (death, new cerebral infarcts, delayed ischemic neurological deficit, rescue therapy) up to week 6.

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.

Isaac Kobrin, MD and Head of Clinical Development, commented: "The information generated from the preliminary analysis of CONSCIOUS-1 demonstrates significance in terms of clazosentan decreasing cerebral vasospasm in a dose-related fashion."

Isaac Kobrin concluded: "A full data analysis and consultation with clinical experts is essential to better understand the apparent disconnect in this study between the significant reduction in cerebral vasospasm and clinical outcome assessed by the endpoint chosen. This full data analysis will determine the future development path."

About CONSCIOUS-1

CONSCIOUS-1 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) was a multi-centre, international, double-blind, randomized, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy of 3 dose levels of clazosentan (15, 5 and 1mg/hour) in preventing the occurrence of cerebral vasospasm following SAH who underwent either clipping or coiling to stop the initial aneurismal bleed, assessed by angiography. As a secondary endpoint, the study also evaluated the ability of clazosentan to reduce the occurrence of early morbidity/mortality as well as overall safety and tolerability of the drug.

CONSCIOUS-1 recruited 413 patients in 52 centers in 11 countries worldwide and was initiated after promising pre-clinical and clinical data that was published in the Journal of Neurosurgery in July 2005 (a).

Reference

(a) Vajkoczy P, Meyer B, Weidauer S et al. Clazosentan (AXV-034343), a selective endothelin A receptor antagonist, in the prevention of cerebral vasospasm following severe aneurysmal subarachnoid hemorrhage: a randomized, double-blind, placebo-controlled, multicenter, Phase IIa study. Journal of Neurosurgery July 2005. 103, 9-17.

NOTES TO THE EDITOR:

About cerebral vasospasm following SAH

Intravascular coiling or surgical clipping is usually required to secure the aneurysm so as to stop the bleeding and prevent further episodes. The vasospasm following SAH occurs when the acute rupture of an aneurysm of the cerebral vessels releases blood into the subarachnoid space of the brain. This blood progressively breaks down in the brain acutely up-regulating the release of endothelin in the subarachnoid space.

Endothelin, a known mediator of vasospasm in the cerebral vasculature, provides a rationale for the use of clazosentan, an intravenous endothelin receptor antagonist, for the prevention of vasospasm.

About aneurysmal SAH

A cerebral aneurysm refers to a blood vessel within the brain that weakens over time and undergoes widening. This usually occurs at the junctions of the large arteries at the base of the brain. As the blood vessel weakens, it begins to bulge out like a balloon. The larger the balloon becomes, the greater the risk it may burst, resulting in hemorrhage (bleeding) into the subarachnoid space (membranous space surrounding the brain) and the ensuing spasm (uncontrollable tightening) of the brain blood vessels, leading to oxygen shortage in the brain cells.

Over a quarter of people (27%) die within the first week following an aneurysmal subarachnoid hemorrhage without treatment. Rebleeding occurs in 50% of the aneurysms within the first six months, and about half of the patients die after a rebleed and a further 20% become disabled.

Actelion Ltd.

Actelion Ltd. is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), 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 focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).

Conference Call

Actelion will host an Investor Conference Call and discussion/Q&A on Monday, 19 June 2006, at 07.30 CEST / 01.30 a.m. EDT / 06.30 BST

Dial: +41 (0) 91 610 56 00 (Europe) +1 (1) 866 291 41 66 (U.S.) +44 207 107 06 11 (U.K.)

Webcast -- Live and replay on demand

Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand.

To access the webcast live, simply visit the link on our homepage http://www.actelion.com 5-10 minutes before the conference is due to start.

Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay through our homepage. After 4 May 2006, it will be stored under Investors/Past Events.

CONTACT: Actelion Ltd. Roland Haefeli, Investor Contact +41 61 565 64 58 +1 650 624 6936 Peter Engel, Media Contact +41 61 565 66 28 +1 650 624 6996 Alan Archer, Product information: +41 79 289 80 83 Gewerbestrasse 16, CH-4123 Allschwil http://www.actelion.com PR agency Alexa Forbes (Packer Forbes) +44 20 8772 1551 Jon Pike (Packer Forbes) +44 20 8772 1551



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES