Phase III Tracleer -- Bosentan -- Study in Chronic Heart Failure Does Not Meet Primary Efficacy Objective.Business Editors/Health & Medical Writers
ALLSCHWIL, Switzerland and SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--Feb. 6, 2002--
Long-Term Data Confirms Safety Profile Observed in Earlier
Pulmonary Arterial Hypertension Trials
Actelion Ltd (SWX:ATLN) and Genentech, Inc. (NYSE NYSE
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One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. ) today announced the Phase III ENABLE program evaluating endothelin receptor antagonist A endothelin receptor antagonist (ERA) is a drug which blocks endothelin receptors.
Two main kinds of ERAs exist:
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The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. NYHA NYHA New York Heart Association Class IIIb/IV) did not reach statistical significance in the two pre-defined primary endpoints: risk reduction in time to death or hospitalization due to CHF, and improvement in clinical status at nine months of treatment.
Isaac Kobrin, Head of Clinical Development at Actelion, commented: "Though we did not see efficacy in CHF for Tracleer, the ENABLE trial did importantly generate long-term data about safety in patients receiving Tracleer for up to 30 months, confirming the same safety profile as observed in earlier clinical trials. This is an important finding for Tracleer's first approved indication, Pulmonary Arterial Hypertension. We are encouraged by this safety finding in a larger patient population and will further evaluate the use of Tracleer in other indications. Actelion is in the process of preparing new clinical trial programs for Tracleer."
Under an agreement concluded in December 2000, in certain circumstances Genentech has opportunity to become a co-promotion partner for Tracleer. An option was exercisable if the ENABLE study reached statistical significance for the primary endpoints. Based on the ENABLE results, Genentech cannot exercise this option but can explore other opportunities under the current agreement.
The full findings of the ENABLE trial, including subgroup analyses, will be presented at the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen.  The organization has 39 chapters in the U.S. meeting, March 17-21, in Atlanta.
Tracleer is currently available in the United States as a treatment for pulmonary arterial hypertension. The drug was approved for this indication by the U.S. Food and Drug Administration on November 20, 2001, and is currently marketed by Actelion Pharmaceuticals US. The drug is also available in Canada and currently under regulatory review in the European Union, Switzerland and Australia.
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fifteen of the currently approved products of biotechnology are based on or stem from Genentech science. Genentech markets ten products directly in the United States. The company has headquarters in South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. and is traded on the New York Stock Exchange New York Stock Exchange (NYSE)
World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol DNA.
Actelion Ltd is a biopharmaceutical company headquartered in Allschwil/Basel Switzerland and has a substantial US operation based in South San Francisco. Actelion 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 Swiss Stock Exchange (SWX:ATLN).