Tracleer and PPH News Actelion Initiates Phase IIb/III Program With Clazosentan
New Study CONSCIOUS-1 to Determine Dose and Clinical Impact Following Encouraging Phase IIa Study Data
ALLSCHWIL, Switzerland, Dec. 22, 2004 (PRIMEZONE) -- Actelion Ltd (Other OTC:ALIOF) (SWX:ATLN) announced today it has initiated the comprehensive global Phase IIb/III development program for clazosentan, an intravenous endothelin receptor antagonist. This follows the completion of discussions with regulatory authorities in both the US and the European Union on all aspects of the clinical program, including clinical efficacy endpoints. The multi-center, international, double-blind, randomized, placebo-controlled, parallel group, dose-finding study CONSCIOUS-1 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) will analyze the efficacy of 3 dose levels of clazosentan in preventing the occurrence of cerebral vasospasm following SAH, assessed by angiography. As a secondary endpoint, the study will also assess the ability of clazosentan to reduce the occurrence of early morbidity/mortality as well as the effect of clazosentan on clinical outcome, and overall tolerability. First centers in Europe have started to screen patients for enrollment in the study, with centers in North America and Israel to follow in early 2005. Overall, the study is expected to recruit 400 patients in 65 centers worldwide. Study results are expected in the first half of 2006. These results will determine the need, size and duration of a potential Phase III study. Promising Phase IIa data shows prevention of vasospasm following SAH Actelion decided to embark on a large-scale pivotal program for clazosentan given the promising results in an earlier Phase IIa study. In this placebo-controlled study with 34 patients, there were significantly fewer and also less severe cases of vasospasms reported in the clazosentan group compared to placebo. Importantly, there were also fewer patients with new cerebral infarcts in the clazosentan group. Infusions of clazosentan were generally well tolerated, with no effects on blood pressure or other vital signs. The full data of this promising Phase IIa study will become available through publication in a peer-reviewed scientific journal in the first half of 2005. In early February, the data will also be presented at the 2005 Joint Annual Meeting of the AANS/CNS Cerebrovascular Section and The American Society of Interventional & Therapeutic Neuroradiology in New Orleans. Actelion and Axovan Actelion acquired clazosentan through its acquisition of privately held Axovan in the fall of 2003. At this point in time, the company paid CHF 53 million out of a total consideration of CHF 231 million. Upon now initiating Phase IIb/III development, Actelion is now making an additional capital payment to Axovan shareholders of CHF 32.5 million. This capital payment, as well as further milestones due upon achieving additional development steps as well as registering and marketing the drug on a global basis, are expected to be treated as Goodwill and are therefore not P&L effective on payment. About vasospasm following subarachnoid hemorrhage (SAH) Vasospasms following subarachnoid hemorrhage (SAH) occur when the rupture of an aneurysm on the cerebral vessels leads to release of blood into the subarachnoid space of the brain. Intravascular coiling or surgical clipping is usually required to stop the bleeding and prevent further episodes. Vasospasm leading to neurological deficits and death tend to occur in the first 3-12 days following the hemorrhage. Currently, there is no satisfactory prevention or treatment option. Actelion Ltd Actelion Ltd is a biopharmaceutical company with its corporate headquarter 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 as well as 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). For further information please contact:
Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil Investor Contact Roland Haefeli +41 61 487 34 58
+1 650 624 6936 Media Contact Peter Engel +41 61 487 36 28
+1 650 624 6996
http://www.actelion.com
Lung Rx, An Emerging Biotech Now Has the Capabilities of Large Pharma, Without the Costly Infrastructure and Employees Usually Needed
SILVER SPRING, Md., June 15 /PRNewswire/ -- Lung Rx, Inc. has launched an important global trial that will take full advantage of a complete trial management system, and fully integrated data capture and clinical data management. Lung Rx launched this trial faster and at less cost than equivalent trials run on paper - and most importantly without the need to manage the CRO with costly internal resources.
This Phase II/III, double blind, placebo-controlled study will evaluate the new Lung Rx product for pulmonary hypertension. "With Numoda as our CRO, we launched this trial on time, after a very short start-up period," said Ted Staub, Senior Director of Clinical Development for Lung Rx, a subsidiary of United Therapeutics. "Most importantly Numoda enables us to proactively manage the trial with minimal internal resources and we have access to ALL the relevant trial information, live, 24x7. At last I have found an integrated suite that is adaptable to my resources and answers the data management dilemma I had experienced for years. That is something that I did not have when I was with a major pharma with a $300MM clinical research budget."
"Numoda enabled us to afford these capabilities, leverage my own staff, and were flexible enough so that I did not need to outsource the whole trial," said Stephanie Luque, Clinical Trial Manager. She added, "We have received excellent feedback from the investigators and their site staff. We made their lives easier and we made it painless to participate in the trial. Moreover, Numoda has the flexibility to make any mid-course corrections for the trial in a fraction of the time otherwise possible."
Rohini Verma, Project Manager for Europe, said, "Here in Europe, I am as up to date as Ted and Stephanie, on a real time basis, as to how all aspects of the trial are progressing - this provides us with so much more control and access." Ann Boris, Head of Clinical for Numoda added: "Numoda provides a complete trial infrastructure, without the usual investment in time and money. Now smaller pharma and biotechs can have an integrated eSuite of clinical trial tools for data management, trial and site management, safety monitoring, and workflow capabilities. We produce better quality trials, faster, without needing to expand their budgets or add additional resources to manage their CRO partner. At any time of the day or night they know exactly what is being done for their trial, and that it is done right."
About Numoda Corporation
Numoda is a global life sciences products and services company with several important distinctions. Numoda enables all trial participants to interact in real-time with all the trial data, all in one place, from anywhere, throughout the trial - making everyone more productive. The result is improved trial speed, data quality and cost savings in Phase I to Phase IV clinical trials. These key results are produced by our important and unique advancements in data management, proactive project management, and the acquisition, integration and processing of data from all sources. Numoda is the first full-service clinical research organization (CRO) to design, implement, and consolidate ALL clinical trials data and trial information, in real time - and Numoda tools can be used by the client's own team. Numoda delivers speed and efficiency, from protocol development through final study report, while providing sponsors with visibility into each study that is simply not possible elsewhere. These claims have been substantiated in successful global trials over many years.
About Lung Rx, Inc.
Lung Rx has developed a form of treprostinil that can be delivered directly to the lung. Lung Rx is currently in Phase II/III clinical trial to investigate the Efficacy and Safety of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension.
For more information, visit http://www.numoda.com.
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Source: Numoda Corporation
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